Clinical Trials List
Protocol NumberR1979-ONC-22102
Active
2023-07-01 - 2029-02-28
Phase III
Recruiting12
A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination with Lenalidomide Versus Rituximab in Combination with Lenalidomide in Relapsed/Refractory Participants with Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
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Trial Applicant
ICON Clinical Research Pte Ltd
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Sponsor
Regeneron Pharmaceuticals, Inc.
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Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chien-Chin Lin Division of Others -
- Huai-Hsuan Huang Division of General Internal Medicine
- 田豐銘 Division of General Internal Medicine
- - - Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
- - - Division of General Internal Medicine
- HSIN-AN HOU Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
- Wen-Chien Chou Division of General Internal Medicine
- WEI-LI MA Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tzu-Yao Liao Division of Hematology & Oncology
- Chia-Lun Chang Division of Hematology & Oncology
- HsingJin Eugene Liu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Ting Hsu Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
- 顏志傑 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳彥谷 無
- 張景明 無
- Ta-Chih Liu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 葉人華 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
- 陳義丰 Division of Hematology & Oncology
- 賴學緯 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 蔡文銓 Division of Hematology & Oncology
- 張平穎 Division of Hematology & Oncology
- 黃子權 Division of Hematology & Oncology
- 戴明燊 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳玟均 無
- Sheng-Hsuan Chien 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王元欽 Division of Hematology & Oncology
- 高小雯 Division of Hematology & Oncology
- HSUAN JEN SHIH Division of Hematology & Oncology
- Ming-Chung Kao Division of Hematology & Oncology
- Tung-Liang Lin Division of Hematology & Oncology
- 洪玉馨 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 莊哲明 Division of Hematology & Oncology
- Jeng-Shiun Du Division of Hematology & Oncology
- Yi-Chang Liu Division of Hematology & Oncology
- Tsung-Jang Yeh Division of Hematology & Oncology
- Hui-Hua Hsiao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
莊博雅
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)
Objectives
Assess the safety, tolerability, and dose-limiting toxicities (DLTs) of odronextamab in combination with lenalidomide in participants with R/R FL.
Test Drug
injection
Active Ingredient
Odronextamab (REGN1979)
LENALIDOMIDE
LENALIDOMIDE
Dosage Form
27C
130
130
Dosage
NA
Endpoints
• The incidence of DLTs for odronextamab in
combination with lenalidomide during the DLT
observation period
• The incidence and severity of treatmentemergent adverse events (TEAEs) for
odronextamab in combination with lenalidomide
combination with lenalidomide during the DLT
observation period
• The incidence and severity of treatmentemergent adverse events (TEAEs) for
odronextamab in combination with lenalidomide
Inclution Criteria
1. Participants must be confirmed to have FL grade 1-3a or MZL (lymph node, spleen, or extranodal MZL) based on local histology as assessed by the trial administrator. Participants with an extranodal MZL subtype suitable for systemic anti-lymphoma therapy will be included. Tumor tissue must be submitted to the central laboratory for trial inclusion. Pre-inclusion histological evaluation using retained tumor tissue is permitted.
2. Participants must have refractory disease or have relapsed after at least one prior systemic chemoimmunotherapy or immunotherapy (for at least two cycles). The prior systemic therapy should contain at least one anti-CD20 antibody, and participants should meet the treatment indications.
Note: Prior lenalidomide treatment is permitted if the approved full dose was tolerated more than 6 months prior to day 1 of cycle 1.
3. Diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) recordings showing measurable disease on cross-sectional imaging (defined as at least one two-dimensional measurable lymph node lesion > 1.5 cm, or the largest cross-sectional diameter (GTD) of extranodal disease > 1 cm, regardless of the minor axis diameter).
4. Male or female must be 18 years of age or older at the time of consent, or the legal age of consent for adulthood as defined by state-specific regulations (whichever is greater).
5. East Coast Cancer Clinical Research Cooperative (ECOG) performance status of 0 to 2.
6. Adequate hematological function, measured by:
• Platelet count ≥ 75 x 10⁹/L. Participants must not have received a platelet transfusion within 7 days prior to the first dose allocation to meet this eligibility requirement.
• Absolute neutrophil count (ANC) ≥ 1.0 x 10⁹/L. Participants must not receive granulocyte colony-stimulating factor (G-CSF) within 2 days prior to the first dose allocation to meet this eligibility requirement.
• Heme concentration ≥ 9 g/dL
Note: Participants with cell counts below the above limits may be considered for inclusion if the trial administrator believes the cause is bone marrow infiltration or splenic blockage due to pre-existing disease.
Note: Participants with bone marrow infiltration or splenic blockage should meet the following hematological parameters:
• Platelet count ≥ 25 x 10⁹/L. Participants must not receive platelet transfusion therapy within 3 days prior to the first dose of odronextamab to meet the platelet eligibility requirement.
• Heme ≥ 7.0 g/dL
• ANC ≥ 0.5 x 10⁹/L Participants must not have received G-CSF within 2 days prior to the first dose of odronextamab to meet ANC eligibility requirements.
7. Adequate organ function is indicated by the following data:
• Echocardiography or multi-channel ventricular function imaging (MUGA) showing a cardiac ejection fraction > 40%
• Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) (≤ 3 × ULN if attributable to hepatic lymphoma infiltration)
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN if attributable to hepatic lymphoma infiltration)
• Alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN if attributable to hepatic lymphoma infiltration)
Note: AST > 3 × ULN and/or [other abnormalities] will be excluded regardless of the presence of hepatic lymphoma infiltration. Participants with ALT > 3 × ULN and total bilirubin > 1.5 × ULN.
Participants with known Gilbert's syndrome and a total bilirubin level > 4 × ULN will be excluded.
• Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 60 mL/min.
Note: Participants with a creatinine clearance measurement (based on 24-hour urine collection or other reliable methods) ≥ 60 mL/min may be considered for inclusion.
8. Understand the purpose and risks of the trial and provide a signed and dated participant consent form, as well as an authorization for the use of protected health information (in accordance with national and local participant privacy regulations).
9. Be willing and able to cooperate with in-clinic follow-ups, trial-related procedures, and complete patient log entries.
10. Be able to understand and complete trial-related questionnaires.
11. Be able and willing to receive appropriate treatment and/or prophylactic treatment for thromboembolic events, based on the clinical judgment of the trial administrator.
12. All trial participants must:
a. Understand the potential teratogenic risks of lenalidomide.
b. Agree to refrain from donating blood during treatment with the investigational drug and for 28 days after discontinuation of lenalidomide.
c. Agree not to share the investigational drug with others.
d. Agree to receive counseling regarding pregnancy precautions and the risks of fetal exposure to lenalidomide.
2. Participants must have refractory disease or have relapsed after at least one prior systemic chemoimmunotherapy or immunotherapy (for at least two cycles). The prior systemic therapy should contain at least one anti-CD20 antibody, and participants should meet the treatment indications.
Note: Prior lenalidomide treatment is permitted if the approved full dose was tolerated more than 6 months prior to day 1 of cycle 1.
3. Diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) recordings showing measurable disease on cross-sectional imaging (defined as at least one two-dimensional measurable lymph node lesion > 1.5 cm, or the largest cross-sectional diameter (GTD) of extranodal disease > 1 cm, regardless of the minor axis diameter).
4. Male or female must be 18 years of age or older at the time of consent, or the legal age of consent for adulthood as defined by state-specific regulations (whichever is greater).
5. East Coast Cancer Clinical Research Cooperative (ECOG) performance status of 0 to 2.
6. Adequate hematological function, measured by:
• Platelet count ≥ 75 x 10⁹/L. Participants must not have received a platelet transfusion within 7 days prior to the first dose allocation to meet this eligibility requirement.
• Absolute neutrophil count (ANC) ≥ 1.0 x 10⁹/L. Participants must not receive granulocyte colony-stimulating factor (G-CSF) within 2 days prior to the first dose allocation to meet this eligibility requirement.
• Heme concentration ≥ 9 g/dL
Note: Participants with cell counts below the above limits may be considered for inclusion if the trial administrator believes the cause is bone marrow infiltration or splenic blockage due to pre-existing disease.
Note: Participants with bone marrow infiltration or splenic blockage should meet the following hematological parameters:
• Platelet count ≥ 25 x 10⁹/L. Participants must not receive platelet transfusion therapy within 3 days prior to the first dose of odronextamab to meet the platelet eligibility requirement.
• Heme ≥ 7.0 g/dL
• ANC ≥ 0.5 x 10⁹/L Participants must not have received G-CSF within 2 days prior to the first dose of odronextamab to meet ANC eligibility requirements.
7. Adequate organ function is indicated by the following data:
• Echocardiography or multi-channel ventricular function imaging (MUGA) showing a cardiac ejection fraction > 40%
• Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) (≤ 3 × ULN if attributable to hepatic lymphoma infiltration)
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 × ULN (≤ 5 × ULN if attributable to hepatic lymphoma infiltration)
• Alkaline phosphatase (ALP) ≤ 2.5 × ULN (≤ 5 × ULN if attributable to hepatic lymphoma infiltration)
Note: AST > 3 × ULN and/or [other abnormalities] will be excluded regardless of the presence of hepatic lymphoma infiltration. Participants with ALT > 3 × ULN and total bilirubin > 1.5 × ULN.
Participants with known Gilbert's syndrome and a total bilirubin level > 4 × ULN will be excluded.
• Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 60 mL/min.
Note: Participants with a creatinine clearance measurement (based on 24-hour urine collection or other reliable methods) ≥ 60 mL/min may be considered for inclusion.
8. Understand the purpose and risks of the trial and provide a signed and dated participant consent form, as well as an authorization for the use of protected health information (in accordance with national and local participant privacy regulations).
9. Be willing and able to cooperate with in-clinic follow-ups, trial-related procedures, and complete patient log entries.
10. Be able to understand and complete trial-related questionnaires.
11. Be able and willing to receive appropriate treatment and/or prophylactic treatment for thromboembolic events, based on the clinical judgment of the trial administrator.
12. All trial participants must:
a. Understand the potential teratogenic risks of lenalidomide.
b. Agree to refrain from donating blood during treatment with the investigational drug and for 28 days after discontinuation of lenalidomide.
c. Agree not to share the investigational drug with others.
d. Agree to receive counseling regarding pregnancy precautions and the risks of fetal exposure to lenalidomide.
Exclusion Criteria
1. Primary central nervous system (CNS) lymphoma, or known involvement by non-primary CNS NHL (current or previous history of CNS involvement).
Note: When suspected lymphoma involvement of the CNS is present, evaluation with CNS imaging (CT or MRI) and lumbar puncture must be performed as appropriate.
2. The participant has histological evidence of transformation to high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
3. A history of or current relevant CNS pathological findings, such as:
• Epilepsy, seizures, hemiparesis, aphasia, stroke, severe brain injury, cerebellar disease, organic brain syndrome, psychosis, or
• Evidence of inflammatory lesions and/or vasculitis on brain MRI
4. Non-NHL malignancies, unless the participant has received appropriate and definitive treatment and has been cancer-free for at least 3 years, excluding localized prostate cancer, cervical carcinoma in situ, breast carcinoma in situ, or non-melanoma skin cancer that has been treated with hormone therapy or localized radiation therapy (i.e., pellet therapy) and has received definitive treatment.
5. Any other major active illness or medical condition that may interfere with the performance of the trial or put the participant at significant risk, including but not limited to major cardiovascular disease (e.g., New York Heart Association Class III or IV heart disease, past 6...). 6. A history of myocardial infarction, unstable arrhythmia, or unstable angina within the past month, or a history of major lung disease (e.g., obstructive pulmonary disease and symptomatic bronchospasm), gastrointestinal, liver, kidney, endocrine, blood, autoimmune, psychiatric, or neurological disorders.
7. Known malabsorption syndrome, or existing gastrointestinal conditions that may impair lenalidomide absorption (e.g., gastric bypass, gastric banding, or other gastric procedures that may alter absorption); lenalidomide cannot be administered via a nasogastric tube following gastrectomy.
8. Participants are at high risk of thromboembolic events and are unwilling to receive prophylactic treatment for venous thromboembolism (VTE).
9. 8. Prior Treatment:
a. Received any anti-lymphoma therapy within 28 days or 5 drug half-lives prior to the start of allocation treatment, whichever is shorter.
b. Received any experimental therapy within 28 days prior to the start of allocation treatment.
c. Underwent major surgery recently (within 4 weeks prior to the start of allocation treatment), except for lymph node biopsies.
d. Received standard radiation therapy within 14 days prior to the first dose of allocation treatment.
Note: Painless radiation therapy is permitted for symptomatic lymph nodes/lesions (if the irradiated lesion or lymph node was not included as a target for tumor evaluation).
e. Used lenalidomide or any CD20xCD3 bispecific antibody within the past 6 months.
f. Received continuous systemic corticosteroid therapy exceeding 10 mg prednisone daily or an anti-inflammatory equivalent within 72 hours prior to the start of allocation treatment.
g. Previous organ transplant recipient
9. Allergic reaction/allergy:
a. History of severe allergic reaction to a compound that is similar in composition to the investigational drug or excipient in a chemical or biological product.
b. Known allergy to both allopurinol and rasburicase.
10. Infection:
a. Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic, or other) at the time of trial enrollment or within 2 weeks thereafter, which requires continued treatment and/or may cause diffuse illness or severe infection during immunosuppression. Evidence of recovery or good control of the infection should be available at the start of the investigational therapy.
b. Active severe special infectious pneumonia (COVID-19) infection
c. Poorly controlled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
d. Cytomegalovirus (CMV) infection, with detectable concentrations based on peripheral blood polymerase chain reaction (PCR) analysis. If a participant exhibits a measurable CMV concentration at screening, they will need to receive appropriate antiviral therapy and will be reconsidered for eligibility only if PCR analysis shows at least two undetectable CMV concentrations (at least 7 days apart).
Note: Participants with well-controlled HIV infection are eligible for inclusion (spontaneous or stable antiretroviral therapy reaching undetectable viral loads, and CD4 count exceeding 350 cells/μL).
Note: If a participant is hepatitis B surface antigen positive or hepatitis B core antibody positive, they should be evaluated by a specialist and deemed to have well-controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) below the minimum detectable concentration, and receiving antiretroviral therapy for hepatitis B) before being approved for participation in the trial.
Note: Participants with positive HCV antibodies and controlled infection (undetectable HCV ribonucleic acid (RNA) by PCR, which may be spontaneous or a response to a previously successful anti-HCV therapy course) are eligible for inclusion.
11. Receive an active vaccine within 28 days prior to starting treatment allocation.
12. Participants required to reside in the facility due to orders issued by judicial or administrative authorities.
13. Members of the clinical trial center's trial team and/or their immediate family members, unless prior approval is obtained from the trial commissioner.
14. Pregnant or breastfeeding women.
Note: Before commencing the trial treatment, women of childbearing age must have two negative pregnancy tests confirmed by the trial physician. She must agree to continue pregnancy testing during the trial and must also test positive after the trial treatment concludes. This requirement applies even if the participant completely abstains from heterosexual intercourse.
Female participants must agree to avoid breastfeeding during the trial treatment and for at least 28 days after discontinuing lenalidomide, or for at least 6 months after discontinuing rituximab (whichever is longer).
15. Women of childbearing potential who are unwilling to use highly effective contraception for at least 6 months before the first dose/start of the first treatment, during the trial, and for 12 months after the last dose of odronextamab or 12 months after the last dose of rituximab (whichever is longer) (WOCBP)*. Women must commit to abstaining from heterosexual intercourse or using two reliable methods of contraception (excluding the use of estrogen-containing oral contraceptives) for 4 weeks before starting lenalidomide treatment, during treatment, during intermittent periods, and for 4 weeks after stopping lenalidomide treatment. Highly effective contraceptive methods include:
a. Stable use of progestin-only hormonal contraceptives (oral, injectable, implantable) that work by inhibiting ovulation and are used two or more menstrual cycles prior to the screening.
b. Intrauterine devices (IUDs); Intrauterine hormone-releasing systems (IUS)
c. Bilateral tubal occlusion/ligation
d. Vasectomy/partner vasectomy† (provided the male partner undergoing the vasectomy is the participant's only sexual partner and the partner has been medically assessed as having had a successful vasectomy).
e. Abstinence ‡,§ WOCBP requires pregnancy testing and contraception. Postmenopausal or permanently sterilized women do not require pregnancy testing and contraception.
Postmenopausal status is defined as the absence of menstruation for 12 months without other medical cause. High follicle-stimulating hormone (FSH) levels within the postmenopausal range can be used to confirm postmenopausal status in women not using hormonal contraception or hormone replacement therapy. However, a single FSH test is insufficient to determine the occurrence of postmenopausal status unless there has been no menstruation for at least 12 months. The following definitions are based on the Clinical Trials Facilitation Panel guidelines.
*A woman of fertility is defined as a woman who has started menstruation and has not yet reached menopause, unless she has undergone permanent sterilization. Methods of permanent sterilization include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
†Partners or trial participants who have undergone vasectomy must have undergone a medical evaluation regarding the success of the procedure.
‡Abstinence can only be considered a highly effective method if it involves abstinence from heterosexual intercourse for the entire period defined as having investigational drug-related risks. The reliability of abstinence must be assessed in light of the length of the clinical trial period and the participant's preferred lifestyle.
§Periodic abstinence (natural family planning, sympathobasic temperature method, post-ovulation method), withdrawal (coitus interruptus), spermicide-only methods, and lactational amenorrhea are not acceptable methods of contraception. Male and female condoms should not be used simultaneously.
Male participants who are unwilling to use condoms as contraception with all fertile female partners using highly effective methods of contraception before the start of the initial dose/first treatment, during the trial, and for at least 6 months after receiving the last dose of odronextamab.
Male participants receiving lenalidomide:
• Must abstain completely from sex during the trial, the intermittent period, and for at least 28 days after discontinuing lenalidomide, or agree to use condoms during sexual intercourse with WOCBP, even if he has successfully undergone vasectomy.
• Must agree not to donate semen during the treatment with the investigational drug and for 28 days after discontinuing lenalidomide.
Sperm and egg donation is prohibited during the trial and for 6 months (whichever is longer) after receiving the last dose of odronextamab or other investigational drug (according to the applicable and approved package insert).
This condition was removed in Revision 2, 2016.
Note: When suspected lymphoma involvement of the CNS is present, evaluation with CNS imaging (CT or MRI) and lumbar puncture must be performed as appropriate.
2. The participant has histological evidence of transformation to high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
3. A history of or current relevant CNS pathological findings, such as:
• Epilepsy, seizures, hemiparesis, aphasia, stroke, severe brain injury, cerebellar disease, organic brain syndrome, psychosis, or
• Evidence of inflammatory lesions and/or vasculitis on brain MRI
4. Non-NHL malignancies, unless the participant has received appropriate and definitive treatment and has been cancer-free for at least 3 years, excluding localized prostate cancer, cervical carcinoma in situ, breast carcinoma in situ, or non-melanoma skin cancer that has been treated with hormone therapy or localized radiation therapy (i.e., pellet therapy) and has received definitive treatment.
5. Any other major active illness or medical condition that may interfere with the performance of the trial or put the participant at significant risk, including but not limited to major cardiovascular disease (e.g., New York Heart Association Class III or IV heart disease, past 6...). 6. A history of myocardial infarction, unstable arrhythmia, or unstable angina within the past month, or a history of major lung disease (e.g., obstructive pulmonary disease and symptomatic bronchospasm), gastrointestinal, liver, kidney, endocrine, blood, autoimmune, psychiatric, or neurological disorders.
7. Known malabsorption syndrome, or existing gastrointestinal conditions that may impair lenalidomide absorption (e.g., gastric bypass, gastric banding, or other gastric procedures that may alter absorption); lenalidomide cannot be administered via a nasogastric tube following gastrectomy.
8. Participants are at high risk of thromboembolic events and are unwilling to receive prophylactic treatment for venous thromboembolism (VTE).
9. 8. Prior Treatment:
a. Received any anti-lymphoma therapy within 28 days or 5 drug half-lives prior to the start of allocation treatment, whichever is shorter.
b. Received any experimental therapy within 28 days prior to the start of allocation treatment.
c. Underwent major surgery recently (within 4 weeks prior to the start of allocation treatment), except for lymph node biopsies.
d. Received standard radiation therapy within 14 days prior to the first dose of allocation treatment.
Note: Painless radiation therapy is permitted for symptomatic lymph nodes/lesions (if the irradiated lesion or lymph node was not included as a target for tumor evaluation).
e. Used lenalidomide or any CD20xCD3 bispecific antibody within the past 6 months.
f. Received continuous systemic corticosteroid therapy exceeding 10 mg prednisone daily or an anti-inflammatory equivalent within 72 hours prior to the start of allocation treatment.
g. Previous organ transplant recipient
9. Allergic reaction/allergy:
a. History of severe allergic reaction to a compound that is similar in composition to the investigational drug or excipient in a chemical or biological product.
b. Known allergy to both allopurinol and rasburicase.
10. Infection:
a. Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic, or other) at the time of trial enrollment or within 2 weeks thereafter, which requires continued treatment and/or may cause diffuse illness or severe infection during immunosuppression. Evidence of recovery or good control of the infection should be available at the start of the investigational therapy.
b. Active severe special infectious pneumonia (COVID-19) infection
c. Poorly controlled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
d. Cytomegalovirus (CMV) infection, with detectable concentrations based on peripheral blood polymerase chain reaction (PCR) analysis. If a participant exhibits a measurable CMV concentration at screening, they will need to receive appropriate antiviral therapy and will be reconsidered for eligibility only if PCR analysis shows at least two undetectable CMV concentrations (at least 7 days apart).
Note: Participants with well-controlled HIV infection are eligible for inclusion (spontaneous or stable antiretroviral therapy reaching undetectable viral loads, and CD4 count exceeding 350 cells/μL).
Note: If a participant is hepatitis B surface antigen positive or hepatitis B core antibody positive, they should be evaluated by a specialist and deemed to have well-controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) below the minimum detectable concentration, and receiving antiretroviral therapy for hepatitis B) before being approved for participation in the trial.
Note: Participants with positive HCV antibodies and controlled infection (undetectable HCV ribonucleic acid (RNA) by PCR, which may be spontaneous or a response to a previously successful anti-HCV therapy course) are eligible for inclusion.
11. Receive an active vaccine within 28 days prior to starting treatment allocation.
12. Participants required to reside in the facility due to orders issued by judicial or administrative authorities.
13. Members of the clinical trial center's trial team and/or their immediate family members, unless prior approval is obtained from the trial commissioner.
14. Pregnant or breastfeeding women.
Note: Before commencing the trial treatment, women of childbearing age must have two negative pregnancy tests confirmed by the trial physician. She must agree to continue pregnancy testing during the trial and must also test positive after the trial treatment concludes. This requirement applies even if the participant completely abstains from heterosexual intercourse.
Female participants must agree to avoid breastfeeding during the trial treatment and for at least 28 days after discontinuing lenalidomide, or for at least 6 months after discontinuing rituximab (whichever is longer).
15. Women of childbearing potential who are unwilling to use highly effective contraception for at least 6 months before the first dose/start of the first treatment, during the trial, and for 12 months after the last dose of odronextamab or 12 months after the last dose of rituximab (whichever is longer) (WOCBP)*. Women must commit to abstaining from heterosexual intercourse or using two reliable methods of contraception (excluding the use of estrogen-containing oral contraceptives) for 4 weeks before starting lenalidomide treatment, during treatment, during intermittent periods, and for 4 weeks after stopping lenalidomide treatment. Highly effective contraceptive methods include:
a. Stable use of progestin-only hormonal contraceptives (oral, injectable, implantable) that work by inhibiting ovulation and are used two or more menstrual cycles prior to the screening.
b. Intrauterine devices (IUDs); Intrauterine hormone-releasing systems (IUS)
c. Bilateral tubal occlusion/ligation
d. Vasectomy/partner vasectomy† (provided the male partner undergoing the vasectomy is the participant's only sexual partner and the partner has been medically assessed as having had a successful vasectomy).
e. Abstinence ‡,§ WOCBP requires pregnancy testing and contraception. Postmenopausal or permanently sterilized women do not require pregnancy testing and contraception.
Postmenopausal status is defined as the absence of menstruation for 12 months without other medical cause. High follicle-stimulating hormone (FSH) levels within the postmenopausal range can be used to confirm postmenopausal status in women not using hormonal contraception or hormone replacement therapy. However, a single FSH test is insufficient to determine the occurrence of postmenopausal status unless there has been no menstruation for at least 12 months. The following definitions are based on the Clinical Trials Facilitation Panel guidelines.
*A woman of fertility is defined as a woman who has started menstruation and has not yet reached menopause, unless she has undergone permanent sterilization. Methods of permanent sterilization include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
†Partners or trial participants who have undergone vasectomy must have undergone a medical evaluation regarding the success of the procedure.
‡Abstinence can only be considered a highly effective method if it involves abstinence from heterosexual intercourse for the entire period defined as having investigational drug-related risks. The reliability of abstinence must be assessed in light of the length of the clinical trial period and the participant's preferred lifestyle.
§Periodic abstinence (natural family planning, sympathobasic temperature method, post-ovulation method), withdrawal (coitus interruptus), spermicide-only methods, and lactational amenorrhea are not acceptable methods of contraception. Male and female condoms should not be used simultaneously.
Male participants who are unwilling to use condoms as contraception with all fertile female partners using highly effective methods of contraception before the start of the initial dose/first treatment, during the trial, and for at least 6 months after receiving the last dose of odronextamab.
Male participants receiving lenalidomide:
• Must abstain completely from sex during the trial, the intermittent period, and for at least 28 days after discontinuing lenalidomide, or agree to use condoms during sexual intercourse with WOCBP, even if he has successfully undergone vasectomy.
• Must agree not to donate semen during the treatment with the investigational drug and for 28 days after discontinuing lenalidomide.
Sperm and egg donation is prohibited during the trial and for 6 months (whichever is longer) after receiving the last dose of odronextamab or other investigational drug (according to the applicable and approved package insert).
This condition was removed in Revision 2, 2016.
The Estimated Number of Participants
-
Taiwan
60 participants
-
Global
470 participants
