Softer chemo before stem cell transplant aims to cure blood cancers in frail children

NCT ID NCT01572181

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 test a reduced-toxicity conditioning regimen before allogeneic stem cell transplant in children and young adults with blood cancers. The regimen combines fludarabine, full-dose busulfan, and anti-thymocyte globulin. The trial measures transplant-related mortality at one year and tracks engraftment and survival. Participants are aged 1 to 25 who cannot tolerate standard myeloablative conditioning.

What this could mean

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

Active substance
A conditioning regimen of fludarabine, busulfan, and anti-thymocyte globulin given before stem cell transplant
What this could lead to
If successful, this regimen could offer a safer path to curative stem cell transplant for children with blood cancers who are too frail for standard conditioning.
What could go wrong
This is a Phase 2 trial with 50 participants, so results may not apply broadly. The regimen still carries risks of transplant-related complications, and it may not control the cancer as well as standard treatment.

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

50 people

The number who actually took part.

Started

Apr 2012

Finished

Oct 2017

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

12 months to 25 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 * Children and adolescents aged over 12 months and under 25 years * Availability of an HLA identical family donor or an HLA-matched unrelated donor (10/10 or 9/10 if the mismatch level is at HLACw for an unrelated donor) or availability of an HLA matched cord blood (5/6 or 6/6) * Informed consent signed by patients (18-25 years) and patient's legal representative, parent(s) or guardian (cf p13) * Diagnosis of a hematologic malignancy which is a candidate for allo-HSCT, but not eligible for standard or conventional myeloablative conditioning regimens because of high risk for toxicity. * Are considered as criteria of non-eligibility for standard or conventional myeloablative conditioning: * a history of autologous or allogeneic stem cell transplantation * comorbidities or medical history predictive of a prohibitive rate of TRM and toxicity with the use of standard high dose chemotherapy and / or radiotherapy. Exclusion Criteria: * Patient has been administered any other systemic chemotherapeutic drug (including Gemtuzumab) within 21 days prior to trial enrollment and start of the conditioning regimen. Hydroxyurea is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed leptomeningeal disease, that has been in remission for at least 3 months prior to enrollment on this study. * Active infection. Protocol PI will be final arbiter if there is uncertainty regarding whether a previous infection is resolved. * Children and adolescents who are not older than 12 months and under 25 years * A donor who is HLA mismatched at the level of more than one locus. * Poor performance status (Lansky \< 50%) * Life expectancy is severely limited by concomitant illness and expected to be \<12 weeks. * Left ventricular ejection fraction \< 30%. Uncontrolled arrhythmias or symptomatic cardiac disease. * Symptomatic pulmonary disease. FEV1, FVC and DLCO \<30% of expected corrected for hemoglobin. * Creatinine clearance less than 30 mL/m per 1.73 m2 or requiring dialysis * Evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy. * Effusion or ascites \>1L prior to drainage. * HIV-positive. * Female pregnancy * Absence of effective contraception among boys and girls of childbearing potential (that contraception should be continued until 6 months after stopping treatment) * Breastfeeding * Patient's legal representative, parent(s) or guardian not able to sign informed consent. * children's refusal * Hypersensitivity to rabbit proteins, to the active substance or to any of the excipients of experimental products

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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

  • University Hopsital

    Paris, France

  • University Hopsital

    Rouen, France

  • University Hospital

    Besançon, France

  • University Hospital

    Bordeaux, France

  • University Hospital

    Clermont-Ferrand, France

  • University Hospital

    Grenoble, France

  • University Hospital

    Lille, France

  • University Hospital

    Lyon, France

  • University Hospital

    Marseille, France

  • University Hospital

    Montpellier, France

  • University Hospital

    Nancy, France

  • University Hospital

    Nantes, France

  • University Hospital

    Paris, France

  • University Hospital

    Rennes, France

  • University Hospital

    Strasbourg, France

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