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About
This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL).
Full description
This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's lymphoma (NHL). Each study arm will be conducted in a predefined disease subset. All study arms are open label and allocation to each study arm will not be randomized.
As this master platform protocol has multiple study arms, subjects can be screened for several study arms at once. Likewise, a subject who ends participation in one study arm may be rescreened for participation in another (separate) study arm.
The primary objective of the study is to evaluate the safety of targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL). This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment.
Enrollment
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Volunteers
Inclusion criteria
Inclusion Criteria For All Arms:
Inclusion Criteria for Arm 1:
Ineligibility for high-dose therapy with stem cell rescue and/or CAR T-cell therapy will be determined by the investigator.
Inclusion Criteria for Arm 2:
Ineligibility for high-dose therapy with stem cell rescue and/or CAR T-cell therapy will be determined by the investigator.
Inclusion Criteria for Arm 3:
Ineligibility for high-dose therapy with stem cell rescue and/or CAR T-cell therapy will be determined by the investigator.
Inclusion Criteria for Arm 4:
Ineligibility for high-dose therapy with stem cell rescue and/or CAR T-cell therapy will be determined by the investigator.
Exclusion criteria
Exclusion Criteria For All Arms:
Exclusion Criteria for Arm 1:
Exclusion Criteria for Arm 2:
Exclusion Criteria for Arm 3:
Exclusion Criteria for Arm 4:
Primary purpose
Allocation
Interventional model
Masking
30 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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