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Gentler transplant prep aims to cure tough blood cancers

NCT ID NCT00863148

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

Researchers test a reduced-intensity conditioning regimen before allogeneic stem cell transplant in adults with high-risk AML, MDS, or ALL who cannot tolerate standard intensive treatment. The regimen combines clofarabine, busulfan, and thymoglobulin. The trial measures relapse rate at one year and monitors safety.

What this could mean

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

Active substance
clofarabine combined with busulfan and thymoglobulin as a reduced-intensity conditioning regimen before donor stem cell transplant
What this could lead to
If successful, this regimen could offer a curative stem cell transplant option to adults with high-risk blood cancers who are too frail for standard intensive conditioning.
What could go wrong
This is a small, early-phase trial without a comparison group, so any benefit is uncertain. The regimen still carries risks of toxicity, infection, and graft-versus-host disease.

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

Oct 2009

Finished

Jun 2013

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: * Age 18 to 65 * For patients younger than 50 years, cons-indication for the use of a standard myeloablative conditioning (history of hematopoietic stem cell transplantation autologous or allogeneic, or the presence of co-morbidities or medical history making prohibitive in terms toxicity using chemotherapy and / or high dose radiotherapy as judged by the referring physician) - MDS, ALL or AML at high risk, WHO THE biphenotypic-Score \<2 * Any primary diagnosis of high-risk MDS/AML or ALL eligible for a treatment by reduced intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (allo-SCT) * Suitable donor available (related or matched unrelated) * Cardiac: LV Ejection Fraction ≥ 50% by MUGA or Echocardiogram. * Pulmonary: FEV1 and FVC ≥ 50% predicted, and DLCO (corrected for hemoglobin) ≥ 50% of predicted * Adequate renal and hepatic function * Performance status: Karnofsky ≥ 70% * Informed consent signed by patient prior to enrolment Exclusion Criteria: * Age \<18 * Age \>65 * Known hypersensitivity to clofarabine or excipients- Other hematologic malignancies than ALL, AML and MDS * Patients with prior standard allogeneic HSCT with grade \> 2 aGvHD * Prior standard allogeneic transplantation if \< 2 months * Contra-indication to one of the drug of the RIC regimen . * Patient with \> 3 treatment lines prior to inclusion * Pregnant or lactating females * Patient HIV+, Hep B+, Hep C+- Uncontrolled systemic infection * Performance Status Score ECOG \> 2- Known central nervous system involvement with AML or ALL- Uncontrolled active infection of any kind or bleeding * Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen. * For patients younger than 50 years, possibly indicating a standard myeloablative conditioning

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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

  • CHRU Hautepierre

    Strasbourg, 67098, France

  • CHU Haut-Lévêque

    Pessac, 33604, France

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • Hôpital Saint Louis

    Paris, 75475, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Nantes University hospital

    Nantes, 44093, France

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