Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL

Phase 2

Completed

• Conditions: Diffuse Large B Cell Lymphoma; Hodgkin Lymphoma; Peripheral T-Cell Lymphoma
• Interventions: Drug: Pembrolizumab

• Registration Number: NCT02362997
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation therapy after autologous stem cell transplant (ASCT), in patients with relapsed or refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or peripheral T-cell lymphoma (PTCL) in 1st remission.

Detailed Description

Pembrolizumab is an antibody drug that blocks a molecule called PD-1. PD-1 is a receptor molecule on the surface of immune cells that can be used to turn off the immune response. Some cancers use this as a way to turn off the immune response against them. Blocking PD-1 with pembrolizumabmay restore an effective immune attack against the lymphoma cells.

On this study, patients who undergo ASCT for R/R cHL, DLBCL or PTCL in 1st remission will receive pembrolizumab at a dose of 200mg intravenously every 3 weeks for up to 8 cycles, beginning within a few weeks of ASCT.

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-13
• Study Start: 2015-04
• Primary Completion: 2021-10-26
• Results First Submitted: 2022-09-26
• Results First Submitted QC: 2022-11-10
• Results First Posted: 2022-12-08
• Study Completion: 2023-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peripheral T cell lymphoma	Pembrolizumab	Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Diffuse large B cell lymphoma	Pembrolizumab	Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
Classical Hodgkin lymphoma	Pembrolizumab	Pembrolizumab 200mg IV every 3 weeks up to 8 cycles

Primary Outcome Measures

Name	Time	Method
Progression-free Survival After ASCT	18 Months	Proportion of patients alive and disease-free 18 months from autologous stem cell transplantation (ASCT). Progression criteria are per Lugano 2014 criteria. All patients receiving any amount of protocol treatment. Patients who have progressed or lost to follow-up prior to 18 months are counted as failures; only patients followed and progression-free for at least 18 months are counted as successes.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	18 Months	Survival probability of patients alive 18 months from ASCT, time-to-event
Relapse	18 Months	Number of patients who relapse within 18 months from autologous stem cell transplantation.
Safety and Tolerability Assessed by CTCAE v4 Grade 2 and Above Toxicity Related to Study Treatment	6 months	Number of patients who experienced at least a grade 2 toxicity with "definite," "probable," or "possible" attribute to study treatment, according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Progression-free Survival	18 months	Progression-free survival probability of patients who are alive and without progression 18 months from ASCT, time-to-event
Response Rate to Pembrolizumab	18 months	In patients with measurable disease after ASCT, rate of objective response after treatment. Response was assessed using the Lugano 2014 criteria.

Trial Locations

Locations (6)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States