CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 12 enrolled
Drug / intervention
Pembrolizumabdrug
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02981914
NCT02981914Early Ph 1Completed

Pilot Study of Pembrolizumab Treatment for Disease Relapse After Allogeneic Stem Cell Transplantation

University of Chicago·interventional·Posted Dec 5, 2016·Updated Apr 22, 2024

In Brief

A Early Phase 1 clinical trial evaluating Pembrolizumab for Classical Hodgkin Lymphoma and 3 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This pilot study has been designed to investigate the safety of pembrolizumab treatment for disease relapse following allogeneic stem cell transplant (alloSCT). Pembrolizumab will be administered at a fixed dose of 200 mg IV every 3 weeks. Approximately 12-26 patients with relapsed MDS, AML, or mature B cell (B-NHL, cHL) malignancies that have relapsed following alloSCT will be enrolled on this trial. Pembrolizumab treatment will be administered for up to 24 months, provided that neither disease progression, nor development of a dose-limiting toxicity (DLT), has occurred. Adverse events will be monitored every three weeks throughout the trial and graded in severity according to the guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. This trial will be conducted in accordance with Good Clinical Practices.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 5, 2016
Enrollment StartMar 7, 2017
Primary CompletionOct 9, 2020
Study CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.6 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab will be administered at a fixed dose of 200 mg IV every 3 weeks for a max of 24 months, so long as there is no disease progression.