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Can a Pre-Transplant drug keep leukemia from returning?

NCT ID NCT07003737

Disease control Sponsor: First Affiliated Hospital of Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether giving blinatumomab, a drug that helps the immune system destroy leukemia cells, before a stem cell transplant can improve outcomes for adults with high-risk B-cell acute lymphoblastic leukemia (B-ALL). Participants who are in remission and have no detectable disease will be randomly assigned to receive either a short course of blinatumomab before the transplant or proceed directly to transplant. The main goal is to see if the extra treatment extends the time people live without the leukemia coming back.

What this could mean

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

Active substance
blinatumomab, a drug that helps immune cells attack leukemia cells, given as a short course before a stem cell transplant
What this could lead to
If it works, adding blinatumomab before a stem cell transplant could lower the chance of leukemia returning and improve long-term survival for people with high-risk B-ALL.
What could go wrong
This is a randomized trial, but the drug can cause serious side effects like cytokine release syndrome and nervous system problems. The benefit is not guaranteed, and results may not apply to all patients.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

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 to 65 years

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: 1\. Diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) according to the 2022 WHO classification. 2\. Age between 18 and 65 years. 3. Meets the National Comprehensive Cancer Network (NCCN) criteria for high-risk B-ALL, based on clinical or cytogenetic/molecular features: 1. Clinical high-risk features (any of the following): 1. Age \> 35 years 2. Peripheral WBC count \> 30 × 10⁹/L 3. Cytogenetic/molecular high-risk features (any of the following): 2. Cytogenetic and molecular high-risk features (at least one of the following): 1. Hypodiploidy (\<44 chromosomes) 2. TP53 mutation 3. KMT2A rearrangement 4. MLL rearrangement 5. HLF rearrangement 6. ZNF384 rearrangement 7. MEF2D rearrangement 8. MYC rearrangement 9. BCR-ABL1-like (Ph-like) ALL, including: 10. JAK pathway rearrangements (CRLF2r, EPORr, JAK1/2/3r, TYK2r, SH2B3 mutation, IL7R mutation, JAK1/2/3 mutations) 11. ABL-class rearrangements (ABL1, ABL2, PDGFRA, PDGFRB, FGFR1) 12. Other kinase fusions (e.g., NTRK3r, FLT3r, LYNr, PTK2Br) 13. PAX5alt 14. t(9;22)(q34.1;q11.2); BCR-ABL1 with IKZF1 mutation and/or prior chronic myeloid leukemia (CML) 15. Intrachromosomal amplification of chromosome 21 (iAMP21) 16. IKZF1 alteration 17. Complex karyotype (≥5 chromosomal abnormalities) 4. CD19-positive by immunophenotyping. 5. BCR::ABL1-negative. 6. Achieved complete remission (CR) after induction therapy. 7. Measurable residual disease (MRD)-negative by flow cytometry (FCM). 8. Availability of a matched sibling donor, haploidentical related donor, or matched/unmatched unrelated donor. 9\. ECOG performance status score of 0-2. 10. Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault formula). 11. AST and ALT ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN. 12. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography. 13. Expected survival \> 8 weeks. 14. Signed written informed consent, with ability to understand and comply with the study protocol. Exclusion Criteria: 1. Prior exposure to blinatumomab, chimeric antigen receptor (CAR) T-cell therapy, or anti-CD22 immunotoxins. 2. Clinically significant cardiovascular disease, including uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, NYHA class III or IV heart disease, or myocardial infarction within 3 months prior to screening. 3. Other severe comorbidities that may limit participation in the trial (e.g., severe infection, renal failure). 4. Known HIV infection or uncontrolled severe viral hepatitis. 5. Pregnant or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Neoplasm, Residual precursor B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia, B-precursor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

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