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Younger donors may improve stem cell transplant success for leukemia patients

NCT ID NCT04547049

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares stem cell transplants from two types of donors for people with leukemia or myelodysplastic syndromes (MDS): younger non-family members (age 40 or under) and older first-degree relatives (over 50). The goal is to see which donor leads to better overall survival. The trial involves 232 participants and uses a standard chemotherapy and transplant procedure. It is currently active but no longer recruiting new participants.

What this could mean

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

Active substance
stem cell transplant (haploidentical hematopoietic stem cell transplantation)
What this could lead to
If successful, this could show that using stem cells from younger, non-family donors leads to better survival and fewer complications than using older family donors.
What could go wrong
This is a Phase 3 trial, but results may not apply to all patients. Stem cell transplants carry serious risks like infection, graft-versus-host disease, and organ damage.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 232 people

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

Started

Sep 2020

Expected to finish

Apr 2026

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

13 to 78 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.

Patient Inclusion Criteria: * Patient age 13-78 years * Absence of a suitable HLA identical related or unrelated hematopoietic stem cell donor * Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50 * Presence of both HLA haploidentical young non-first-degree (age ≤ 40) and older first-degree (age \>50) donors Eligible diagnoses: AML（excluding APL） with at least one of the following: * median- or high- risk according to the WHO prognostic stratification system * failure to achieve CR after 2 cycles of induction chemotherapy * AML arising from MDS or a myeloproliferative disorder, or secondary AML * patients in CR2 or beyond Mixed-phenotype acute leukemia (MPAL) in morphological remission Acute lymphoblastic leukemia (T or B) in morphological remission MDS with at least one of the following: * IPSS score of INT-2 or greater * IPSS score of INT-1 with life-threatening cytopenias, including those generally requiring greater than weekly transfusions * A first allo-HCT * Adequate end-organ function * ECOG performance status \< 2 * No other contraindications for HSCT * Signature of the informed consent Patient Exclusion Criteria * Availability of suitable HLA identical related or unrelated hematopoietic stem cell donors * Availability of suitable partially HLA-mismatched (haploidentical), first-degree related donor aged between 18 and 50 * Not the first allo-HCT * Presence of uncontrolled bacterial, viral, or fungal infection * Patients with severe heart, lung, liver and kidney insufficiency * HIV-positive patients * Women of childbearing potential who are pregnant (β-HCG+) or breast feeding * Patients with a psychiatric history * ECOG performance status ≥ 2 * Patients with malignancies other than the primary disease * Refusal to sign the informed consent Donor Inclusion Criteria: * The donor and recipient must be HLA haploidentical * Meets institutional selection criteria and medically fit to donate * Lack of recipient anti-donor HLA antibody Donor Exclusion Criteria: * The donor and recipient are HLA identical * Has not donated blood products to recipient

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia leukemia mixed phenotype acute leukemia myelodysplastic syndrome

As listed by the trial registrant

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

Leukemia MDS

Contacts and locations

Locations

  • The Affiliated People's Hospital of Ningbo University

    Ningbo, China

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, China

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, China

  • Xiangya Hospital Central South University

    Changsha, China

  • Xinqiao Hospital, State Key Laboratory of Trauma and Chemical Poisoning, Army Medical University

    Chongqing, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, China

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Other studies related to the condition(s) this trial covers.