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

Completed · Phase 1/Phase 2

Conditions studied: B-Cell Acute Lymphoblastic Leukemia, Adult

In brief

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 facts

Study ID: NCT03160079
Run by: University of California, San Diego
People needed: 16
Starts: 2017-08-04
Expected to finish: 2023-06-23
Last updated by the study team: 2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL) having received at least 1 prior line of therapy
Philadelphia chromosome positive (Ph+), or Breakpoint Cluster Region Protein-Abelson Murine Leukemia Viral Oncogene Homolog 1 (BCR-ABL1) positive B-lineage ALL must have failed at least 1 second or third generation tyrosine kinase inhibitor (TKI) or be intolerant to TKIs
Greater than 50% lymphoblasts on screening bone marrow aspirate or biopsy
Adequate organ function
Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication.
A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy.

You may not qualify if…

Allogeneic hematopoietic cell transplantation within 5 years of study drug administration
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) or Granulocyte Colony-Stimulating Factor (G-CSF) use within 2 weeks of study treatment and throughout the study
Prior checkpoint inhibitor therapy including anti Programmed Death Receptor 1 (anti-PD1), anti-PD-L1, anti-CTLA4 (cytotoxic T-lymphocyte-associated protein 4), anti tumor necrosis factor receptor superfamily, member 9 (anti-CD137), or anti-PD-L2 therapy
Active Central Nervous System (CNS) or testicular involvement by leukemia
History of neurologic disorder
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
Burkitt lymphoma/leukemia
Has a diagnosis of congenital immunodeficiency
Has a known history of active Bacillus Tuberculosis (TB)
Known Human Immunodeficiency Virus (HIV) infection
Active hepatitis B or hepatitis C infection
Has received a live vaccine within 30 days prior to first dose
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
History of autoimmune disease
Known interstitial lung disease
Any evidence of active, non-infectious pneumonitis or has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Patients who have received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 2 weeks earlier.
Patients who are less than 4 weeks from surgery or have insufficient recovery from surgical-related trauma or wound healing.
Known impaired cardiac function

Where it is running

UCSF Fresno Community Cancer Institute — Clovis, California, United States
UC San Diego Moores Cancer Center — La Jolla, California, United States
UC Irvine Health Chao Family Comprehensive Cancer Center — Orange, California, United States
UCSF Comprehensive Cancer Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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