Clinical Trials List
Protocol NumberD7310C00001
2020-05-12 - 2023-12-31
Phase III
Recruiting9
A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor
-
Trial Applicant
-
Sponsor
AstraZeneca
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Sheng-Yu Chen 無
- Ling-Wei Wang 無
- 陳盛裕 未分科
- Mu-Hsin Chang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
9 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kwang-Yu Chang 無
- Shang-Yin Wu 無
- 劉奕廷 無
- Sen-Tien Tsai 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
- Chia-Hsun Hsieh 無
- Shu-Hang Ag 無
- Chi-Ting Liau 無
- 廖俊達 無
- Pei-Wei Huang 無
- Tzu-Chen Yen 無
- Cheng-Lung Hsu 無
- Li-Yu Lee 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Objectives
The aim of this study is to assess the efficacy and safety of monalizumab and
cetuximab compared to placebo and cetuximab in participants with R/M SCCHN after
receiving an ICI and platinum-based chemotherapy, regardless of the sequence of these
therapies. Monalizumab is a first-in-class ICI that blocks the inhibitory CD94/NKG2A
receptor resulting in the stimulation of NK cell and CD8+ T cell cytolytic activity.
Additionally, monalizumab enhances human NK-cell ADCC mediated by cetuximab. While
monalizumab monotherapy has shown limited clinical activity, encouraging antitumor results
have been observed following monalizumab and cetuximab combination therapy in patients
with R/M SCCHN who have received prior platinum-based chemotherapy, including patients
who have also received prior therapy with an ICI. This dual targeting could therefore provide
greater antitumor activity than cetuximab alone. The combination of monalizumab and
cetuximab could be a key option to improve clinical outcomes in patients with R/M SCCHN
after receiving an ICI.
Test Drug
Monalizumab
Cetuximab(ErbituxR)
Cetuximab(ErbituxR)
Active Ingredient
Humanized anti-NKG2A mAb
Chimeric anti-EGFR mAb
Chimeric anti-EGFR mAb
Dosage Form
注射液
注射液
注射液
Dosage
50 mg/mL
5 mg/mL
5 mg/mL
Endpoints
Primary
To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of OS
Secondary
To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of PFS, ORR, and DoR
To assess disease-related symptoms, functioning, and HRQoL in participants treated with monalizumab and cetuximab (Arm A) compared to placebo and cetuximab (Arm B) using the EORTC QLQ-C30 and the EORTC QLQ-H&N35 questionnaires
To assess the PK of monalizumab
To investigate the immunogenicity of monalizumab
To characterize the association between clinical outcome and protein expression in the tumor microenvironment in participants treated with monalizumab and cetuximab (Arm A) or placebo and cetuximab (Arm B)
To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of OS
Secondary
To compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of PFS, ORR, and DoR
To assess disease-related symptoms, functioning, and HRQoL in participants treated with monalizumab and cetuximab (Arm A) compared to placebo and cetuximab (Arm B) using the EORTC QLQ-C30 and the EORTC QLQ-H&N35 questionnaires
To assess the PK of monalizumab
To investigate the immunogenicity of monalizumab
To characterize the association between clinical outcome and protein expression in the tumor microenvironment in participants treated with monalizumab and cetuximab (Arm A) or placebo and cetuximab (Arm B)
Inclution Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
1 Participant must be ≥ 18 years of age at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2 Histologically or cytologically confirmed R/M SCCHN of the oral cavity, oropharynx,
hypopharynx, or larynx who have progressed on or after previous systemic cancer therapy
and are not amenable to curative therapy
3 Must have received prior treatment with a systemic PD-(L)1 inhibitor (in any setting)
4 Prior platinum failure as defined by either:
− Disease progression during or after treatment with a platinum-containing regimen for
R/M disease or
− Recurrence/progression within 6 months of the last dose of platinum as part of
multimodal therapy for LA disease
5 Received 1 or 2 prior systemic regimens for R/M SCCHN (see Section 6.3.1 for
additional detail on prior lines of therapy)
6 At least one lesion that qualifies as a RECIST 1.1 TL at baseline (see Appendix F).
Tumor assessment by CT scan or MRI must be performed within 28 days prior to
randomization.
7 Provide fresh or recently acquired tumor tissue (≤ 3 months prior to screening) for the
purpose of biomarker testing. Tumor tissue collected when previous treatments were still
ongoing is not acceptable.
− Tumor tissue beyond the 3-month window and up to 6 months old may be considered
with Sponsor consultation provided that no intervening systemic regimen was
ongoing.
8 For participants with OPC only: known HPV status prior to randomization (see
Section 6.3.1)
9 WHO/ECOG PS of 0 or 1 at enrollment
10 Adequate organ function, defined as:
(a) Hemoglobin ≥ 9.0 g/dL
(b) Absolute neutrophil count ≥ 1500/mm3
(c) Platelets ≥ 75,000/mm3
(d) Total bilirubin ≤ 1.5 × institutional ULN. This will not apply to participants with
confirmed Gilbert’s syndrome, who will be allowed in consultation with their
physician.
(e) Aspartate aminotransferase and ALT ≤ 2.5 × institutional ULN; for participants with
hepatic metastases, ALT and AST ≤ 5 × ULN
(f) Measured CrCL ≥ 30 mL/min or calculated CrCL ≥ 30 mL/min as determined by
Cockcroft-Gault (using actual body weight)
o Males:
CrCL(mL/min) = Weight (kg) × (140 - age)
72 × serum creatinine (mg/dL)
o Females:
CrCL (mL/min) = Weight (kg) × (140 - age) × 0.85
72 × serum creatinine (mg/dL)
11 Minimum life expectancy of 12 weeks
Weight
12 Body weight > 30 kg
Sex
13 Male and/or female
Reproduction
14 Negative pregnancy test (“highly effective” urine or serum test) for female participants of
childbearing potential.
15 Female participants must be one year post-menopausal, surgically sterile, or using an
acceptable method of contraception (see Appendix G) for the duration of the study (from
the time they sign consent) and for 4 months after the last dose of study intervention to
prevent pregnancy.
16 Male participants must be surgically sterile or using an acceptable method of
contraception (see Appendix G) for the duration of the study (from the time they sign
consent) and for 4 months after the last dose of study intervention to prevent pregnancy in
a female partner. Male participants must not donate or bank sperm during the same time
period.
Informed Consent
17 Capable of giving signed informed consent as described in Appendix A which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol
18 Provision of signed and dated, written ICF prior to any mandatory study specific
procedures, sampling, and analyses
19 Provision of signed and dated written informed consent for genetic sample and analysis
(optional)
20 Provision of signed and dated written Optional Genetic Research Information informed
consent prior to collection of samples for optional genetic research that supports Genomic
Initiative
Age
1 Participant must be ≥ 18 years of age at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2 Histologically or cytologically confirmed R/M SCCHN of the oral cavity, oropharynx,
hypopharynx, or larynx who have progressed on or after previous systemic cancer therapy
and are not amenable to curative therapy
3 Must have received prior treatment with a systemic PD-(L)1 inhibitor (in any setting)
4 Prior platinum failure as defined by either:
− Disease progression during or after treatment with a platinum-containing regimen for
R/M disease or
− Recurrence/progression within 6 months of the last dose of platinum as part of
multimodal therapy for LA disease
5 Received 1 or 2 prior systemic regimens for R/M SCCHN (see Section 6.3.1 for
additional detail on prior lines of therapy)
6 At least one lesion that qualifies as a RECIST 1.1 TL at baseline (see Appendix F).
Tumor assessment by CT scan or MRI must be performed within 28 days prior to
randomization.
7 Provide fresh or recently acquired tumor tissue (≤ 3 months prior to screening) for the
purpose of biomarker testing. Tumor tissue collected when previous treatments were still
ongoing is not acceptable.
− Tumor tissue beyond the 3-month window and up to 6 months old may be considered
with Sponsor consultation provided that no intervening systemic regimen was
ongoing.
8 For participants with OPC only: known HPV status prior to randomization (see
Section 6.3.1)
9 WHO/ECOG PS of 0 or 1 at enrollment
10 Adequate organ function, defined as:
(a) Hemoglobin ≥ 9.0 g/dL
(b) Absolute neutrophil count ≥ 1500/mm3
(c) Platelets ≥ 75,000/mm3
(d) Total bilirubin ≤ 1.5 × institutional ULN. This will not apply to participants with
confirmed Gilbert’s syndrome, who will be allowed in consultation with their
physician.
(e) Aspartate aminotransferase and ALT ≤ 2.5 × institutional ULN; for participants with
hepatic metastases, ALT and AST ≤ 5 × ULN
(f) Measured CrCL ≥ 30 mL/min or calculated CrCL ≥ 30 mL/min as determined by
Cockcroft-Gault (using actual body weight)
o Males:
CrCL(mL/min) = Weight (kg) × (140 - age)
72 × serum creatinine (mg/dL)
o Females:
CrCL (mL/min) = Weight (kg) × (140 - age) × 0.85
72 × serum creatinine (mg/dL)
11 Minimum life expectancy of 12 weeks
Weight
12 Body weight > 30 kg
Sex
13 Male and/or female
Reproduction
14 Negative pregnancy test (“highly effective” urine or serum test) for female participants of
childbearing potential.
15 Female participants must be one year post-menopausal, surgically sterile, or using an
acceptable method of contraception (see Appendix G) for the duration of the study (from
the time they sign consent) and for 4 months after the last dose of study intervention to
prevent pregnancy.
16 Male participants must be surgically sterile or using an acceptable method of
contraception (see Appendix G) for the duration of the study (from the time they sign
consent) and for 4 months after the last dose of study intervention to prevent pregnancy in
a female partner. Male participants must not donate or bank sperm during the same time
period.
Informed Consent
17 Capable of giving signed informed consent as described in Appendix A which includes
compliance with the requirements and restrictions listed in the ICF and in this protocol
18 Provision of signed and dated, written ICF prior to any mandatory study specific
procedures, sampling, and analyses
19 Provision of signed and dated written informed consent for genetic sample and analysis
(optional)
20 Provision of signed and dated written Optional Genetic Research Information informed
consent prior to collection of samples for optional genetic research that supports Genomic
Initiative
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1 Histologically or cytologically confirmed head and neck cancer of any other primary
anatomic location in the head and neck not specified in the inclusion criteria including
participants with squamous cell carcinoma of unknown primary or non-squamous
histologies (eg, nasopharynx or salivary gland)
2 Prior cetuximab therapy (unless it was administered in curative LA setting with
radiotherapy and no disease progression for at least 6 months following the last cetuximab
dose)
3 Any unresolved toxicity NCI CTCAE ≥ Grade 2 from previous anticancer therapy with
the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criteria.
− Participants with irreversible toxicity not reasonably expected to be exacerbated by
treatment with monalizumab and cetuximab may be included only after consultation
with the Medical Monitor.
4 Has carcinomatous meningitis and/or untreated central nervous system metastases
identified either on the baseline brain imaging (see Appendix F) obtained during the
screening period or identified prior to signing the ICF. Participants with a history of brain
metastases or with suspected brain metastases at screening must have an MRI (preferred)
or CT each preferably with iv contrast of the brain prior to study entry. Participants whose
brain metastases have been treated may participate provided they show radiographic
stability (defined as 2 brain images, both of which are obtained after treatment to the
brain metastases. These imaging scans should both be obtained at least 4 weeks apart and
show no evidence of intracranial progression). In addition, any neurologic symptoms that
developed either as a result of the brain metastases or their treatment must have resolved
or be stable either, without the use of steroids, or are stable on a steroid dose of
≤ 10 mg/day of prednisone or its equivalent and anticonvulsants for at least 14 days prior
to the start of treatment. Brain metastases will not be recorded as RECIST 1.1 TL at
baseline.
5 Major surgical procedure (as defined by the investigator) within 28 days prior to the first
dose of study intervention. Note: Local surgery of isolated lesions for palliative intent is
acceptable.
6 History of allogeneic organ transplantation
7 History of allergic reactions or hypersensitivity attributed to compounds of similar
chemical or biologic composition to cetuximab and monalizumab or any of their
excipients
8 History of active primary immunodeficiency
9 Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the
exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or
Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid
arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
− Participants with vitiligo or alopecia
− Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement
− Any chronic skin condition that does not require systemic therapy
− Participants without active disease in the last 5 years may be included but only after
consultation with the Medical Monitor
− Participants with celiac disease controlled by diet alone
10 Active infection including tuberculosis (clinical evaluation that includes clinical history,
physical examination and radiographic findings, and tuberculosis testing in line with local
practice), hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C
(HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies). Participants
with a past or resolved HBV infection (defined as the presence of hepatitis B core
antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for HCV
antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
11 Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection,
symptomatic congestive heart failure, uncontrolled hypertension, unstable angina
pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations
that would limit compliance with study requirement, substantially increase risk of
incurring AEs or compromise the ability of the participant to give written informed
consent
12 History of another primary malignancy except for:
− Malignancy treated with curative intent and with no known active disease ≥ 5 years
before the first dose of study treatment and of low potential risk for recurrence
− Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease
− Adequately treated carcinoma in situ without evidence of disease
− Participants with a history of prostate cancer (tumor/node/metastasis stage) of
Stage ≤ T2cN0M0 without biochemical recurrence or progression and who in the
opinion of the investigator are not deemed to require active intervention
13 Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 500 ms
calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
Prior/Concomitant Therapy
14 Any concurrent anticancer treatment. Concurrent use of hormonal therapy for
non-cancer-related conditions (eg, hormone replacement therapy) is allowed.
15 Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine
therapy, targeted therapy, biologic therapy, tumor embolization, mAbs, or investigational
agents) or radiotherapy with curative intent (to more than 30% of the bone marrow or
with a wide field of radiation) ≤ 28 days prior to the first dose of study intervention. If
sufficient wash-out time has not occurred due to the schedule or PK properties of an
anticancer agent, a longer wash-out period will be required, as agreed by the Sponsor and
the investigator.
16 Current or prior use of immunosuppressive medication within 14 days before the first
dose of study intervention. The following are exceptions to this criterion (see also
Table 6):
− Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular
injection)
− Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone
or its equivalent
− Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
17 Receipt of live attenuated vaccine within 30 days prior to the first dose of study
intervention.
Note: Participants, if enrolled, should not receive live vaccine whilst receiving study
intervention and up to 30 days after the last dose of study intervention.
Prior/Concurrent Clinical Study Experience
18 Participation in another clinical study with an investigational product administered in the
last 28 days prior to randomization or concurrent enrollment in another clinical study,
unless it is an observational (non-interventional) clinical study or during the follow-up
period of an interventional study
19 Prior treatment with monalizumab
Other Exclusions
20 Involvement in the planning and/or conduct of the study (applies to both Sponsor staff
and/or staff at the study site).
21 Judgment by the investigator that the participant should not participate in the study if the
participant is unlikely to comply with study procedures, restrictions and requirements.
22 Previous study intervention assignment in the present study.
23 For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
24 Genetics research study (optional):
Exclusion criteria for participation in the optional (DNA) genetics research component of
the study include:
− Previous allogeneic bone marrow transplant
− Transfusion of non-leukocyte-depleted blood or blood components within 120 days
of genetic sample collection
Medical Conditions
1 Histologically or cytologically confirmed head and neck cancer of any other primary
anatomic location in the head and neck not specified in the inclusion criteria including
participants with squamous cell carcinoma of unknown primary or non-squamous
histologies (eg, nasopharynx or salivary gland)
2 Prior cetuximab therapy (unless it was administered in curative LA setting with
radiotherapy and no disease progression for at least 6 months following the last cetuximab
dose)
3 Any unresolved toxicity NCI CTCAE ≥ Grade 2 from previous anticancer therapy with
the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion
criteria.
− Participants with irreversible toxicity not reasonably expected to be exacerbated by
treatment with monalizumab and cetuximab may be included only after consultation
with the Medical Monitor.
4 Has carcinomatous meningitis and/or untreated central nervous system metastases
identified either on the baseline brain imaging (see Appendix F) obtained during the
screening period or identified prior to signing the ICF. Participants with a history of brain
metastases or with suspected brain metastases at screening must have an MRI (preferred)
or CT each preferably with iv contrast of the brain prior to study entry. Participants whose
brain metastases have been treated may participate provided they show radiographic
stability (defined as 2 brain images, both of which are obtained after treatment to the
brain metastases. These imaging scans should both be obtained at least 4 weeks apart and
show no evidence of intracranial progression). In addition, any neurologic symptoms that
developed either as a result of the brain metastases or their treatment must have resolved
or be stable either, without the use of steroids, or are stable on a steroid dose of
≤ 10 mg/day of prednisone or its equivalent and anticonvulsants for at least 14 days prior
to the start of treatment. Brain metastases will not be recorded as RECIST 1.1 TL at
baseline.
5 Major surgical procedure (as defined by the investigator) within 28 days prior to the first
dose of study intervention. Note: Local surgery of isolated lesions for palliative intent is
acceptable.
6 History of allogeneic organ transplantation
7 History of allergic reactions or hypersensitivity attributed to compounds of similar
chemical or biologic composition to cetuximab and monalizumab or any of their
excipients
8 History of active primary immunodeficiency
9 Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the
exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or
Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid
arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
− Participants with vitiligo or alopecia
− Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement
− Any chronic skin condition that does not require systemic therapy
− Participants without active disease in the last 5 years may be included but only after
consultation with the Medical Monitor
− Participants with celiac disease controlled by diet alone
10 Active infection including tuberculosis (clinical evaluation that includes clinical history,
physical examination and radiographic findings, and tuberculosis testing in line with local
practice), hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C
(HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies). Participants
with a past or resolved HBV infection (defined as the presence of hepatitis B core
antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for HCV
antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
11 Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection,
symptomatic congestive heart failure, uncontrolled hypertension, unstable angina
pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic
gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations
that would limit compliance with study requirement, substantially increase risk of
incurring AEs or compromise the ability of the participant to give written informed
consent
12 History of another primary malignancy except for:
− Malignancy treated with curative intent and with no known active disease ≥ 5 years
before the first dose of study treatment and of low potential risk for recurrence
− Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease
− Adequately treated carcinoma in situ without evidence of disease
− Participants with a history of prostate cancer (tumor/node/metastasis stage) of
Stage ≤ T2cN0M0 without biochemical recurrence or progression and who in the
opinion of the investigator are not deemed to require active intervention
13 Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 500 ms
calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
Prior/Concomitant Therapy
14 Any concurrent anticancer treatment. Concurrent use of hormonal therapy for
non-cancer-related conditions (eg, hormone replacement therapy) is allowed.
15 Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine
therapy, targeted therapy, biologic therapy, tumor embolization, mAbs, or investigational
agents) or radiotherapy with curative intent (to more than 30% of the bone marrow or
with a wide field of radiation) ≤ 28 days prior to the first dose of study intervention. If
sufficient wash-out time has not occurred due to the schedule or PK properties of an
anticancer agent, a longer wash-out period will be required, as agreed by the Sponsor and
the investigator.
16 Current or prior use of immunosuppressive medication within 14 days before the first
dose of study intervention. The following are exceptions to this criterion (see also
Table 6):
− Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular
injection)
− Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone
or its equivalent
− Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
17 Receipt of live attenuated vaccine within 30 days prior to the first dose of study
intervention.
Note: Participants, if enrolled, should not receive live vaccine whilst receiving study
intervention and up to 30 days after the last dose of study intervention.
Prior/Concurrent Clinical Study Experience
18 Participation in another clinical study with an investigational product administered in the
last 28 days prior to randomization or concurrent enrollment in another clinical study,
unless it is an observational (non-interventional) clinical study or during the follow-up
period of an interventional study
19 Prior treatment with monalizumab
Other Exclusions
20 Involvement in the planning and/or conduct of the study (applies to both Sponsor staff
and/or staff at the study site).
21 Judgment by the investigator that the participant should not participate in the study if the
participant is unlikely to comply with study procedures, restrictions and requirements.
22 Previous study intervention assignment in the present study.
23 For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
24 Genetics research study (optional):
Exclusion criteria for participation in the optional (DNA) genetics research component of
the study include:
− Previous allogeneic bone marrow transplant
− Transfusion of non-leukocyte-depleted blood or blood components within 120 days
of genetic sample collection
The Estimated Number of Participants
-
Taiwan
39 participants
-
Global
600 participants
