Anti-ICOS Monoclonal Antibody MEDI-570 in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Follicular Variant or Angioimmunoblastic T-cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 46
Summary
- Conditions
- Recurrent Grade 1 Follicular Lymphoma
- Advanced Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Recurrent Angioimmunoblastic T-Cell Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3a Follicular Lymphoma
- Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
- Recurrent Mycosis Fungoides
- Refractory Grade 3a Follicular Lymphoma
- Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
- Refractory Angioimmunoblastic T-Cell Lymphoma
- Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Refractory Grade 1 Follicular Lymphoma
- Stage IV Mycosis Fungoides AJCC v7
- Stage IB Mycosis Fungoides AJCC v7
- Stage III Mycosis Fungoides AJCC v7
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage II Mycosis Fungoides AJCC v7
- Refractory Grade 2 Follicular Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the safety, maximum tolerated dose and recommended phase II dose (RP2D) of anti-ICOS monoclonal antibody MEDI-570 (MEDI-570) in patients with refractory/relapsed peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL...
PRIMARY OBJECTIVE: I. To determine the safety, maximum tolerated dose and recommended phase II dose (RP2D) of anti-ICOS monoclonal antibody MEDI-570 (MEDI-570) in patients with refractory/relapsed peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), follicular lymphoma, mycosis fungoides (MF) and cutaneous T-cell lymphomas (CTCL). SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetic profile of MEDI-570. II. To evaluate the overall response rate (ORR) and progression free survival (PFS) of MEDI-570 at all dose levels and in a 10-patient expansion cohort at the maximum tolerated dose (MTD). III. To determine short and long term effects of MEDI-570 at all dose levels on the immune system and on T-cell lymphocyte subsets. IV. To determine the relationship between ICOS expression on tumor cells and response to MEDI-570. EXPLORATORY OBJECTIVE: I. To evaluate biomarkers of response and resistance to MEDI-570 in the study population. OUTLINE: This is a dose-escalation study. Patients receive anti-ICOS monoclonal antibody MEDI-570 intravenously (IV) over 1-4 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 6 weeks for 12 weeks.
Tracking Information
- NCT #
- NCT02520791
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Julio C Chavez University Health Network Princess Margaret Cancer Center LAO
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