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Can a drug and donor cells stop leukemia from returning after transplant?

NCT ID NCT01541280

Prevention Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether giving azacitidine, a chemotherapy drug, together with donor lymphocyte infusions after a stem cell transplant can prevent relapse in people with high-risk acute myeloid leukemia or myelodysplastic syndrome. About 30 patients will receive the combination for up to a year after their transplant. The trial tracks how many patients stay relapse-free at two years, along with overall survival and side effects.

What this could mean

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

Active substance
azacitidine combined with donor lymphocyte infusions
What this could lead to
If it works, this approach could offer a way to keep high-risk leukemia and MDS from coming back after a stem cell transplant.
What could go wrong
The trial is small and early-stage, so results may not hold up in larger studies. The treatment can cause immune reactions against healthy tissue and serious infections.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Start date

Nov 2011

Finished

Jul 2015

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 70 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: * Patients with high risk acute myeloid leukemia undergoing allogeneic transplantation with either a familial or an unrelated donor. High risk AML is defined as : * AML in CR1 with unfavorable cytogenetics defined by complex caryotype, autosomal monosomy combined or not with other cytogenetics abnormalities inv(3)/t(3,3), t(6;9), t(6;11), t(11;19), del(5q), del(7q). * AML in CR2 or greater remission prior allogeneic transplantation * AML in PR or relapse prior allogeneic transplantation * Or Patients with high risk myelodysplastic syndrome undergoing allogeneic transplantation with either a familial or an unrelated donor. High risk MDS is defined as : * MDS with intermediate-2 group and higher risk group according to IPSS criteria * Age 18 - 70 years. * Availability of an HLA identical family donor or unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch. * Conditioning regimen to allogeneic transplantation may be either myeloablative or reduced. * Be able to understand and sign informed consent. * Affiliation number to National Health Care System * Men and women of childbearing potential must use effective contraception during and up to 3 months after treatment. Exclusion Criteria: * The presence of any one exclusion criteria renders the patient ineligible: * Patient in full relapse post-transplant (\>20% blasts in the bone marrow) following allogeneic transplant * Documented leukemic infiltration of CNS/cerebrospinal fluid. * Karnofsky performance score below 60%. * Acute and chronic heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease. following allogeneic transplant * Severe liver failure (bilirubin \>30 μmoles/L, SGPT \> 4 X upper limit of normal). * Hepatic malignancy in advanced stage. * Severe neurological or psychiatric disorders * Acute GVHD grade II-III. Patient with grade I GVHD may be included (see annex 1 for GHVD grade definition). * Active uncontrolled infection. * Denied informed consent. * Treatment with other investigational drugs following allogeneic transplantation. * No effective contraception * Lactating females * Pregnant woman

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

Acute myeloid leukemia Myelodysplastic syndrome

Contacts and locations

Locations

  • University Hospital of Nantes

    Nantes, 44000, France

More trials for these conditions

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