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New combo therapy shows promise for relapsed leukemia

NCT ID NCT03160079

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a combination of two drugs—blinatumomab and pembrolizumab—in 16 adults with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who had high levels of cancer cells in their bone marrow. The goal was to see if adding pembrolizumab to blinatumomab could improve the rate of complete remission (no detectable cancer). The study is complete, but results are not yet reported.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blinatumomab and pembrolizumab
What this could lead to
If successful, this combination could improve remission rates for adults with hard-to-treat B-cell acute lymphoblastic leukemia.
What could go wrong
This is an early-phase, small trial (16 participants) with no control group, so results may not be conclusive. The drugs can cause serious side effects like infections or immune reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

16 people

The number who actually took part.

Started

Aug 2017

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UC Irvine Health Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143, United States

  • UCSF Fresno Community Cancer Institute

    Clovis, California, 93611, United States

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