Gentler transplant prep aims to cure tough blood cancers
NCT ID NCT00863148
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for ALL are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Breath test aims to classify leukaemia in hours, not days
- Can a Four-Drug prep make curative transplant safer for older AML patients?
- Can a Chemo-Transplant combo rescue patients whose leukemia resists standard treatment?
- Can a liposomal chemo combo improve outcomes before stem cell transplant?
- Can a new drug regimen beat the standard for stem cell transplant complications?
- Can a targeted pill keep leukemia from returning after transplant?