Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04541017
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-09-05
Brief Title:
Testing the Addition of an Anti-cancer Drug Hu5F9-G4 Magrolimab to the Usual Chemotherapy Treatment Mogamulizumab in T-Cell a Type of Immune Cell Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1b2 Study of Hu5F9-G4 Magrolimab in Combination With Mogamulizumab in RelapsedRefractory Treated T-Cell Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IbII trial identifies the best dose and possible benefits andor side effects of magrolimab when given in combination with mogamulizumab in treating patients with stage IB-IV mycosis fungoides or Sezary syndrome types of T-cell lymphoma that has come back relapsed or does not respond to treatment refractory Magrolimab and mogamulizumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread Treatment with magrolimab in combination with mogamulizumab may stabilize cancer for longer period than the usual treatment in patients with relapsedrefractory T-cell lymphoma who have been previously treated
Detailed Description:
PRIMARY OBJECTIVES
I To characterize the safety and toxicity profile and to determine a safe recommended phase 2 dose RP2D of Hu5F9-G4 magrolimab when given in combination with mogamulizumab Phase I II To compare the proportion of patients who achieve a partial or complete response lasting at least 6 months ORR6 of the combination of Hu5F9-G4 magrolimab and mogamulizumab versus mogamulizumab alone Phase II
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity Phase I
II To compare the efficacy of the combination of Hu5F9-G4 magrolimab and mogamulizumab versus mogamulizumab alone with respect to the following endpoints Phase II
IIa Overall response rate ORR overall response rate lasting at least 4 months ORR4 overall response rate lasting at least 12 months ORR12
IIb Duration of response DOR IIc Progression-free survival PFS IId Time to next treatment TTNT
EXPLORATORY OBJECTIVES
I To identify potential biomarkers that correlate with response to mogamulizumab and Hu5F9-G4 magrolimab including Phase I and II
Ia Expression of CCR4 Ib Somatic mutations and germline polymorphisms Ic Phenotyping of lymphoma and immune microenvironment Id Functional assay of phagocytosis
OUTLINE This is a phase Ib dose de-escalation study of magrolimab followed by a phase II study Patients in the phase Ib study receive treatment as in Arm I Patients in the phase II study are randomized to Arm I or Arm II
ARM I Patients receive magrolimab intravenously IV over 2-3 hours weekly during cycles 1-2 then every 2 weeks Q2W during cycles 3-12 Patients also receive mogamulizumab IV over at least 60 minutes weekly during cycle 1 then Q2W during cycles 2-12 Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients undergo positron emission tomography PETcomputed tomography CT or diagnostic CT blood sample collection and may undergo a skin punch biopsy during screening and on study
ARM II Patients receive mogamulizumab IV over at least 60 minutes weekly during cycle 1 then Q2W during cycles 2-12 Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients who have received at least 2 full treatment cycles and have progressive disease PD or have received at least 6 full treatment cycles and have stable disease SD may crossover to Arm I Patients undergo PETCT or diagnostic CT blood sample collection and may undergo a skin punch biopsy during screening and on study
After completion of study treatment patients are followed up every 3 months for 2 years
I To characterize the safety and toxicity profile and to determine a safe recommended phase 2 dose RP2D of Hu5F9-G4 magrolimab when given in combination with mogamulizumab Phase I II To compare the proportion of patients who achieve a partial or complete response lasting at least 6 months ORR6 of the combination of Hu5F9-G4 magrolimab and mogamulizumab versus mogamulizumab alone Phase II
SECONDARY OBJECTIVES
I To observe and record anti-tumor activity Phase I
II To compare the efficacy of the combination of Hu5F9-G4 magrolimab and mogamulizumab versus mogamulizumab alone with respect to the following endpoints Phase II
IIa Overall response rate ORR overall response rate lasting at least 4 months ORR4 overall response rate lasting at least 12 months ORR12
IIb Duration of response DOR IIc Progression-free survival PFS IId Time to next treatment TTNT
EXPLORATORY OBJECTIVES
I To identify potential biomarkers that correlate with response to mogamulizumab and Hu5F9-G4 magrolimab including Phase I and II
Ia Expression of CCR4 Ib Somatic mutations and germline polymorphisms Ic Phenotyping of lymphoma and immune microenvironment Id Functional assay of phagocytosis
OUTLINE This is a phase Ib dose de-escalation study of magrolimab followed by a phase II study Patients in the phase Ib study receive treatment as in Arm I Patients in the phase II study are randomized to Arm I or Arm II
ARM I Patients receive magrolimab intravenously IV over 2-3 hours weekly during cycles 1-2 then every 2 weeks Q2W during cycles 3-12 Patients also receive mogamulizumab IV over at least 60 minutes weekly during cycle 1 then Q2W during cycles 2-12 Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients undergo positron emission tomography PETcomputed tomography CT or diagnostic CT blood sample collection and may undergo a skin punch biopsy during screening and on study
ARM II Patients receive mogamulizumab IV over at least 60 minutes weekly during cycle 1 then Q2W during cycles 2-12 Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity Patients who have received at least 2 full treatment cycles and have progressive disease PD or have received at least 6 full treatment cycles and have stable disease SD may crossover to Arm I Patients undergo PETCT or diagnostic CT blood sample collection and may undergo a skin punch biopsy during screening and on study
After completion of study treatment patients are followed up every 3 months for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA186717 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186717 |
| NCI-2020-06710 | REGISTRY | None | None |
| PHII-203 | None | None | None |
| 10384 | OTHER | None | None |
| 10384 | OTHER | None | None |