Clinical Trials List
Protocol NumberSGN35-031
2020-12-25 - 2025-07-31
Phase III
Recruiting7
ICD-10C82.50
Diffuse follicle center lymphoma, unspecified site
ICD-10C82.59
Diffuse follicle center lymphoma, extranodal and solid organ sites
ICD-10C83.10
Mantle cell lymphoma, unspecified site
ICD-10C83.19
Mantle cell lymphoma, extranodal and solid organ sites
ICD-10C83.30
Diffuse large B-cell lymphoma, unspecified site
ICD-10C83.39
Diffuse large B-cell lymphoma, extranodal and solid organ sites
ICD-10C83.80
Other non-follicular lymphoma, unspecified site
ICD-10C83.89
Other non-follicular lymphoma, extranodal and solid organ sites
ICD-10C84.90
Mature T/NK-cell lymphomas, unspecified, unspecified site
ICD-10C84.99
Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites
ICD-10C84.A0
Cutaneous T-cell lymphoma, unspecified, unspecified site
ICD-10C84.A9
Cutaneous T-cell lymphoma, unspecified, extranodal and solid organ sites
ICD-10C84.Z0
Other mature T/NK-cell lymphomas, unspecified site
ICD-10C84.Z9
Other mature T/NK-cell lymphomas, extranodal and solid organ sites
ICD-10C85.10
Unspecified B-cell lymphoma, unspecified site
ICD-10C85.19
Unspecified B-cell lymphoma, extranodal and solid organ sites
ICD-10C85.20
Mediastinal (thymic) large B-cell lymphoma, unspecified site
ICD-10C85.29
Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites
ICD-10C85.80
Other specified types of non-Hodgkin lymphoma, unspecified site
ICD-10C85.89
Other specified types of non-Hodgkin lymphoma, extranodal and solid organ sites
ICD-10C85.90
Non-Hodgkin lymphoma, unspecified, unspecified site
ICD-10C85.99
Non-Hodgkin lymphoma, unspecified, extranodal and solid organ sites
ICD-10C86.4
Blastic NK-cell lymphoma
ICD-10C88.4
Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma]
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9202.80
Other lymphomas, unspecified, extranodal solid organ sites
A randomized, double-blind, placebo-controlled, active-comparator, multicenter, phase 3 study of brentuximab vedotin or placebo in combination with lenalidomide and rituximab in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
-
Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
-
Sponsor
Seattle Genetics, Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Che-Hung Lin Division of Hematology & Oncology
- Wei-Ching Lin Division of Hematology & Oncology
- Ching Yun Hsieh Division of Hematology & Oncology
- Tzu-Ting Chen Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Ming-Hung Tsai Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳蓉宣 無
- Chia-Jen Liu 無
- 李函叡 無
- 蔡淳光 無
- 吳嘉紘 無
- Yao-Chung Liu 無
- Jyh-Pyng Gau 無
- 陳玟均 無
- Po-Shen Ko 無
- Sheng-Hsuan Chien 無
- Liang-Tsai Hsiao 無
- Ting-An Lin 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林潔 無
- 高小雯 無
- 蘇羿囷 無
- HSUAN JEN SHIH 無
- Ming-Chung Kao 無
- 陳建誠 無
- Jin-Hou Wu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- - - 無
- CHENG-HONG TSAI 無
- Shang-Ju Wu 無
- 劉高郎 無
- MING YAO 無
- - - 無
- Huai-Hsuan Huang 無
- KUAN-YIN KO 無
- HSIN-AN HOU 無
- 田豐銘 無
- 林明恩 無
- SHAN-CHI YU 無
- Chien-Chin Lin 無
- Chieh-Lung Cheng 無
- WEI-LI MA 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
diffuse large B-cell lymphoma (DLBCL)
Objectives
Primary Objectives
● Evaluate and compare progression-free survival
(PFS) between the 2 treatment arms in the intent-totreat
(ITT) population
● Evaluate and compare PFS between the 2 treatment
arms in the CD30-positive population
Key Secondary Objectives
● Evaluate and compare the objective response rate
(ORR) between the 2 treatment arms in the ITT
population
● Evaluate and compare overall survival (OS) between
the 2 treatment arms in the ITT population
● Evaluate and compare OS between the 2 treatment
arms in the CD30-positive population
Other Secondary Objectives
● Evaluate and compare the complete response (CR)
rate between the 2 treatment arms
● Evaluate and compare duration of response between
the 2 treatment arms
● Evaluate the safety and tolerability of the 2 treatment
arms
Exploratory Objectives Corresponding Exploratory Endpoints
● To characterize the relationship of CD30 expression
with clinical responses to brentuximab vedotin,
lenalidomide, and rituximab
Test Drug
Brentuximab Vedotin, Lenalidomide,Rituximab
Active Ingredient
Brentuximab Vedotin
Dosage Form
Powder for concentrate for solution for infusion
Dosage
50mg
Endpoints
Efficacy Assessments
Subjects will be assigned a response status based on imaging and lymphoma assessments. Disease response will
be assessed by a BICR and the investigator according to the Lugano Classification Revised Staging System for
nodal non-Hodgkin and Hodgkin lymphomas. Radiographic disease evaluations, including contrast-enhanced
CT scans of neck, chest, abdomen and pelvis, will be assessed at baseline, then every 6 weeks from
randomization until Week 48 (±7 days), then every 12 weeks (±7 days) thereafter. A PET scan is required at
baseline and every 6 weeks until Week 48 (±7 days), then every 12 weeks (±7 days) thereafter. Once the PET is
negative per the investigator, no further PET scans are required. A diagnostic quality CT-PET scan should also
be performed at the time of suspected clinical progression.
Pharmacokinetic and Immunogenicity Assessments
Blood samples will be obtained for PK and immunogenicity evaluation at protocol-defined time points. PK
parameters to be estimated include concentration at the end of infusion for brentuximab vedotin (Ceoi) and
trough concentration (Ctrough). Immunogenicity will be evaluated with measurements of ADA in serum.
Biomarker Assessments
Tumor samples will be collected for biomarker assessment including, but not limited to CD30 expression by
IHC, prognostic molecular phenotypes, and gene expression profiling. Blood will be collected for
chemokines/cytokines of interest.
Safety Assessments
Safety assessments will include the surveillance and recording of adverse events (AEs), physical examination
findings, and laboratory tests.
Other Assessments
Patient-Reported Outcomes and Health Economics: Health outcomes assessments will include health-related
quality of life and healthcare utilization, which will be described in the statistical analysis plan (SAP).
Subjects will be assigned a response status based on imaging and lymphoma assessments. Disease response will
be assessed by a BICR and the investigator according to the Lugano Classification Revised Staging System for
nodal non-Hodgkin and Hodgkin lymphomas. Radiographic disease evaluations, including contrast-enhanced
CT scans of neck, chest, abdomen and pelvis, will be assessed at baseline, then every 6 weeks from
randomization until Week 48 (±7 days), then every 12 weeks (±7 days) thereafter. A PET scan is required at
baseline and every 6 weeks until Week 48 (±7 days), then every 12 weeks (±7 days) thereafter. Once the PET is
negative per the investigator, no further PET scans are required. A diagnostic quality CT-PET scan should also
be performed at the time of suspected clinical progression.
Pharmacokinetic and Immunogenicity Assessments
Blood samples will be obtained for PK and immunogenicity evaluation at protocol-defined time points. PK
parameters to be estimated include concentration at the end of infusion for brentuximab vedotin (Ceoi) and
trough concentration (Ctrough). Immunogenicity will be evaluated with measurements of ADA in serum.
Biomarker Assessments
Tumor samples will be collected for biomarker assessment including, but not limited to CD30 expression by
IHC, prognostic molecular phenotypes, and gene expression profiling. Blood will be collected for
chemokines/cytokines of interest.
Safety Assessments
Safety assessments will include the surveillance and recording of adverse events (AEs), physical examination
findings, and laboratory tests.
Other Assessments
Patient-Reported Outcomes and Health Economics: Health outcomes assessments will include health-related
quality of life and healthcare utilization, which will be described in the statistical analysis plan (SAP).
Inclution Criteria
1. Subjects with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R
DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically
determined by the most recent local pathology assessment for the purposes of study
eligibility and stratification. The following subtypes of DLBCL are eligible for
enrollment:
a. Not otherwise specified (NOS)
b. Intravascular large B-cell
lymphoma
c. DLBCL associated with chronic
inflammation
d. EBV-positive NOS
e. ALK-positive
f. T-cell-/histiocyte-rich large B-cell
lymphoma
g. Primary mediastinal large B-cell
lymphoma
h. High-grade B-cell lymphoma with
translocations of MYC and BCL2
and/or BCL6 (double-/triple-hit
lymphoma)
i. High-grade NOS B-cell
lymphomas
j. Primary cutaneous DLBCL (leg
type)
k. DLBCL arising from transformed
indolent lymphomas/leukemias
2. Subjects must have R/R disease following ≥2 lines of prior systemic therapy.
3. Subjects must be HSCT or CAR-T ineligible according to the investigator and must meet
at least one of the following criteria:
a. One or more co-morbidities, including cardiac, pulmonary, renal or hepatic
dysfunction that in the opinion of the Investigator make the subject medically unfit to
receive HSCT or CAR-T therapy.
b. Active disease following induction and salvage chemotherapy
c. Inadequate stem cell mobilization (for HSCT)
d. Relapse following prior HSCT or CAR-T
e. Unable to receive CAR-T therapy due to financial, geographic, or insurance issues.
4. Subjects will need to have formalin-fixed paraffin-embedded tumor tissue (obtained
≤4 weeks before Day 1) submitted to the central pathology lab for the determination of
CD30 expression, which will be centrally determined by visual assessment for any
detectable level of CD30 on tumor cells by IHC (using the anti-CD30 BerH2 antibody).
A subject with an archive sample that has had local CD30 testing, and whose recent
biopsy does not contain viable tumor, may be stratified based on the local result. If a
recent biopsy is not available (obtained ≤4 weeks before Day 1) and a biopsy is not
medically feasible or appropriate, contact the medical monitor. If, in the determination of
the investigator, it is not feasible for the subject to undergo central pathology evaluation
prior to randomization, and after discussion with the Medical Monitor, the subject may be
stratified based on CD30 expression from the local pathology lab. Subjects who are
stratified based on local pathology lab results must have archived tumor tissue sent in for
central CD30 evaluation within 2 weeks of enrollment.
5. Age 18 and older.
6. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
7. Subjects must have fluorodeoxyglucose (FDG)-avid disease by positron emission
tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed
tomography (CT), as assessed by the site radiologist within 28 days of Day 1.
8. The following baseline laboratory data within 28 days of Day 1:
a. Absolute neutrophil count (ANC) ≥1000/μL.
b. Platelet count ≥50,000/μL at least 7 days after last chemotherapy with no platelet
transfusion in the 7 days prior to testing.
c. Hemoglobin ≥8.0 g/dL and have not received a transfusion in the 7 days prior to
testing
d. Serum bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for subjects with
Gilbert’s disease or documented hepatic involvement with lymphoma.
e. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 using the
Modification of Diet in Renal Disease (MDRD) study equation.
o eGFR (mL/min/1.73 m2) = 175 x (serum creatinine [Scr])-1.154 x (Age)-0.203 x
(0.742 if female) x (1.212 if African American)
f. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN
or 5.0 x ULN for subjects with documented hepatic involvement with lymphoma.
9. Subjects of childbearing potential, as defined in Section 4.3, under the following
conditions.
a. Must avoid pregnancy for at least 4 weeks before beginning lenalidomide therapy,
during therapy, during dose interruptions, and for at least 12 months after completing
therapy. Subjects must commit either to abstain continuously from heterosexual
sexual intercourse or to use 2 methods of reliable birth control (see Appendix C),
beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy,
during dose interruptions, and continuing for 12 months following discontinuation of
lenalidomide therapy. Two negative serum β-HCG pregnancy tests must be obtained
prior to initiating therapy. The first test should be performed within 10 to 14 days and
the second test performed within 48 hours prior to receiving lenalidomide therapy.
Afterwards, a serum β-HCG pregnancy test must be administered weekly during the
first month, then monthly thereafter in females with regular menstrual cycles or every
2 weeks in subjects with irregular menstrual cycles.
b. Must agree not to try to become pregnant during the study and for at least 12 months
after the final dose of study drug.
c. Must agree not to breastfeed or donate ova, starting at time of informed consent and
continuing through 12 months after the final dose of study drug.
11. The following requirements for subjects who are human immunodeficiency virus
(HIV)-positive:
● CD4+ T-cell counts ≥350 cells/mm3 within 28 days of Day 1
● No acquired immune deficiency syndrome-defining opportunistic infection within the
past 12 months
● On established highly active antiretroviral therapy for at least 4 weeks with an HIV
viral load less than 400 copies/mL within 28 days of Day 1 (see Section 5.6.2 for
subjects receiving strong CYP3A inhibitors).
12. Subjects must be registered into the mandatory lenalidomide REMS®/risk minimization
programs and be willing to comply with its requirements. Per standard lenalidomide
REMS/risk minimization programs requirements, all physicians who prescribe
lenalidomide for research subjects enrolled into this trial, must be registered in, and must
comply with, all requirements of the lenalidomide REMS/risk minimization programs.
13. The subject must provide written informed consent.
DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically
determined by the most recent local pathology assessment for the purposes of study
eligibility and stratification. The following subtypes of DLBCL are eligible for
enrollment:
a. Not otherwise specified (NOS)
b. Intravascular large B-cell
lymphoma
c. DLBCL associated with chronic
inflammation
d. EBV-positive NOS
e. ALK-positive
f. T-cell-/histiocyte-rich large B-cell
lymphoma
g. Primary mediastinal large B-cell
lymphoma
h. High-grade B-cell lymphoma with
translocations of MYC and BCL2
and/or BCL6 (double-/triple-hit
lymphoma)
i. High-grade NOS B-cell
lymphomas
j. Primary cutaneous DLBCL (leg
type)
k. DLBCL arising from transformed
indolent lymphomas/leukemias
2. Subjects must have R/R disease following ≥2 lines of prior systemic therapy.
3. Subjects must be HSCT or CAR-T ineligible according to the investigator and must meet
at least one of the following criteria:
a. One or more co-morbidities, including cardiac, pulmonary, renal or hepatic
dysfunction that in the opinion of the Investigator make the subject medically unfit to
receive HSCT or CAR-T therapy.
b. Active disease following induction and salvage chemotherapy
c. Inadequate stem cell mobilization (for HSCT)
d. Relapse following prior HSCT or CAR-T
e. Unable to receive CAR-T therapy due to financial, geographic, or insurance issues.
4. Subjects will need to have formalin-fixed paraffin-embedded tumor tissue (obtained
≤4 weeks before Day 1) submitted to the central pathology lab for the determination of
CD30 expression, which will be centrally determined by visual assessment for any
detectable level of CD30 on tumor cells by IHC (using the anti-CD30 BerH2 antibody).
A subject with an archive sample that has had local CD30 testing, and whose recent
biopsy does not contain viable tumor, may be stratified based on the local result. If a
recent biopsy is not available (obtained ≤4 weeks before Day 1) and a biopsy is not
medically feasible or appropriate, contact the medical monitor. If, in the determination of
the investigator, it is not feasible for the subject to undergo central pathology evaluation
prior to randomization, and after discussion with the Medical Monitor, the subject may be
stratified based on CD30 expression from the local pathology lab. Subjects who are
stratified based on local pathology lab results must have archived tumor tissue sent in for
central CD30 evaluation within 2 weeks of enrollment.
5. Age 18 and older.
6. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
7. Subjects must have fluorodeoxyglucose (FDG)-avid disease by positron emission
tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed
tomography (CT), as assessed by the site radiologist within 28 days of Day 1.
8. The following baseline laboratory data within 28 days of Day 1:
a. Absolute neutrophil count (ANC) ≥1000/μL.
b. Platelet count ≥50,000/μL at least 7 days after last chemotherapy with no platelet
transfusion in the 7 days prior to testing.
c. Hemoglobin ≥8.0 g/dL and have not received a transfusion in the 7 days prior to
testing
d. Serum bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for subjects with
Gilbert’s disease or documented hepatic involvement with lymphoma.
e. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 using the
Modification of Diet in Renal Disease (MDRD) study equation.
o eGFR (mL/min/1.73 m2) = 175 x (serum creatinine [Scr])-1.154 x (Age)-0.203 x
(0.742 if female) x (1.212 if African American)
f. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN
or 5.0 x ULN for subjects with documented hepatic involvement with lymphoma.
9. Subjects of childbearing potential, as defined in Section 4.3, under the following
conditions.
a. Must avoid pregnancy for at least 4 weeks before beginning lenalidomide therapy,
during therapy, during dose interruptions, and for at least 12 months after completing
therapy. Subjects must commit either to abstain continuously from heterosexual
sexual intercourse or to use 2 methods of reliable birth control (see Appendix C),
beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy,
during dose interruptions, and continuing for 12 months following discontinuation of
lenalidomide therapy. Two negative serum β-HCG pregnancy tests must be obtained
prior to initiating therapy. The first test should be performed within 10 to 14 days and
the second test performed within 48 hours prior to receiving lenalidomide therapy.
Afterwards, a serum β-HCG pregnancy test must be administered weekly during the
first month, then monthly thereafter in females with regular menstrual cycles or every
2 weeks in subjects with irregular menstrual cycles.
b. Must agree not to try to become pregnant during the study and for at least 12 months
after the final dose of study drug.
c. Must agree not to breastfeed or donate ova, starting at time of informed consent and
continuing through 12 months after the final dose of study drug.
11. The following requirements for subjects who are human immunodeficiency virus
(HIV)-positive:
● CD4+ T-cell counts ≥350 cells/mm3 within 28 days of Day 1
● No acquired immune deficiency syndrome-defining opportunistic infection within the
past 12 months
● On established highly active antiretroviral therapy for at least 4 weeks with an HIV
viral load less than 400 copies/mL within 28 days of Day 1 (see Section 5.6.2 for
subjects receiving strong CYP3A inhibitors).
12. Subjects must be registered into the mandatory lenalidomide REMS®/risk minimization
programs and be willing to comply with its requirements. Per standard lenalidomide
REMS/risk minimization programs requirements, all physicians who prescribe
lenalidomide for research subjects enrolled into this trial, must be registered in, and must
comply with, all requirements of the lenalidomide REMS/risk minimization programs.
13. The subject must provide written informed consent.
Exclusion Criteria
1. History of another malignancy within 2 years before the first dose of study drug or any
evidence of residual disease from a previously diagnosed malignancy. Exceptions are
malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as
carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer,
ductal carcinoma in situ, or Stage I uterine cancer.
2. History of progressive multifocal leukoencephalopathy (PML).
3. Active cerebral/meningeal disease related to the underlying malignancy. Subjects with a
history of cerebral/meningeal disease related to the underlying malignancy are allowed if
prior CNS disease has been effectively treated and without progression for at least 3
months.
4. Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or
fungal infection within 2 weeks prior to the first dose of study drug. Routine
antimicrobial prophylaxis is permitted.
5. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with
immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless
underlying disease has progressed on treatment.
6. Subjects who are breastfeeding.
7. Known hypersensitivity to any study drug or excipient contained in the drug formulation
of the study drugs.
8. Known to be positive for hepatitis B by surface antigen expression. Known to be positive
for hepatitis C infection (positive by polymerase chain reaction [PCR] or on antiviral
therapy for hepatitis C within the last 6 months). Subjects who have been treated for
hepatitis C infection are permitted if they have documented sustained virologic response
of 12 weeks.
9. Subjects with previous allogeneic HSCT if they meet either of the following criteria:
● <100 days from HSCT
● Active acute or chronic graft-versus-host disease (GVHD) or receiving
immunosuppressive therapy as treatment for or prophylaxis against GVHD.
10. Previous treatment with brentuximab vedotin or lenalidomide.
11. Current therapy with immunosuppressive medications (including steroids), other
systemic anti-neoplastic, or investigational agents.
a. Prednisone (or equivalent) ≤10 mg/day may be used for non-lymphomatous purposes.
12. Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, pulmonary embolism, or cardiac symptoms
consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior
to the first dose of study drugs.
13. Congestive heart failure, Class III or IV, by the NYHA criteria (see Appendix D).
14. Grade 2 or higher peripheral sensory or motor neuropathy at baseline.
15. Other serious underlying medical condition that, in the opinion of the investigator, would impair the subject’s ability to receive or tolerate the planned treatment, and complete study assessments.
evidence of residual disease from a previously diagnosed malignancy. Exceptions are
malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as
carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer,
ductal carcinoma in situ, or Stage I uterine cancer.
2. History of progressive multifocal leukoencephalopathy (PML).
3. Active cerebral/meningeal disease related to the underlying malignancy. Subjects with a
history of cerebral/meningeal disease related to the underlying malignancy are allowed if
prior CNS disease has been effectively treated and without progression for at least 3
months.
4. Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or
fungal infection within 2 weeks prior to the first dose of study drug. Routine
antimicrobial prophylaxis is permitted.
5. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with
immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless
underlying disease has progressed on treatment.
6. Subjects who are breastfeeding.
7. Known hypersensitivity to any study drug or excipient contained in the drug formulation
of the study drugs.
8. Known to be positive for hepatitis B by surface antigen expression. Known to be positive
for hepatitis C infection (positive by polymerase chain reaction [PCR] or on antiviral
therapy for hepatitis C within the last 6 months). Subjects who have been treated for
hepatitis C infection are permitted if they have documented sustained virologic response
of 12 weeks.
9. Subjects with previous allogeneic HSCT if they meet either of the following criteria:
● <100 days from HSCT
● Active acute or chronic graft-versus-host disease (GVHD) or receiving
immunosuppressive therapy as treatment for or prophylaxis against GVHD.
10. Previous treatment with brentuximab vedotin or lenalidomide.
11. Current therapy with immunosuppressive medications (including steroids), other
systemic anti-neoplastic, or investigational agents.
a. Prednisone (or equivalent) ≤10 mg/day may be used for non-lymphomatous purposes.
12. Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, pulmonary embolism, or cardiac symptoms
consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior
to the first dose of study drugs.
13. Congestive heart failure, Class III or IV, by the NYHA criteria (see Appendix D).
14. Grade 2 or higher peripheral sensory or motor neuropathy at baseline.
15. Other serious underlying medical condition that, in the opinion of the investigator, would impair the subject’s ability to receive or tolerate the planned treatment, and complete study assessments.
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
400 participants
