Blinatumomab & Pembrolizumab for Adults With Relapsed/Refractory B-cell ALL With High Marrow Lymphoblasts

Part of paid clinical trials in Clovis, California.

Sponsor
University of California, San Diego
Study ID
NCT03160079
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • B-Cell Acute Lymphoblastic Leukemia, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • blinatumomab — DRUG
    Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle length 42 days
  • pembrolizumab — DRUG
    Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg) Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)

Study Details

This is a Phase I/II study of blinatumomab in combination with pembrolizumab in adult patients with relapsed or refractory B-lineage ALL (B-ALL). The primary objective of this study is to determine if the addition of pembrolizumab to blinatumomab improves the Complete Response Rate (CR) and Complete Remission with Partial Hematologic Recovery (CRh) relative to blinatumomab alone in adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia with high bone marrow lymphoblast percentage (\>50% lymphoblasts).

Key Dates

Start date
Aug 4, 2017
Status verified
Oct 2025
Primary completion
Dec 21, 2021
Completion
Jun 23, 2023

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Blinatumomab + Pembrolizumab
    Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day) Cycle length 42 days Other Names: Blincyto Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg) Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg) Other Names: * Keytruda * MK-3475

Primary Outcome Measure

Best Overall Response Rate (ORR) [ Time Frame: 28 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCSF Fresno Community Cancer InstituteClovisCalifornia93611-
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
UC Irvine Health Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
UCSF Comprehensive Cancer CenterSan FranciscoCalifornia94143-

Related coverage on Hipa.ai

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By research site
UCSF Fresno Community Cancer Institute· Clovis, CAUC San Diego Moores Cancer Center· La Jolla, CAUC Irvine Health Chao Family Comprehensive Cancer Center· Orange, CAUCSF Comprehensive Cancer Center· San Francisco, CA

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