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Can a Chemo-Transplant combo rescue patients whose leukemia resists standard treatment?

NCT ID NCT01188174

Cure Sponsor: Nantes University Hospital 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

This trial tests a treatment strategy for adults with acute myeloid leukemia (AML) that did not respond to standard induction chemotherapy. Participants receive clofarabine and intermediate-dose Ara-C chemotherapy, followed by a reduced-intensity allogeneic stem cell transplant using donor cells. The goal is to see whether this sequential approach improves survival at two years after transplant. The trial enrolls adults aged 18 to 55 who have a suitable matched donor.

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 intermediate-dose cytarabine (Ara-C) chemotherapy, followed by a reduced-intensity allogeneic stem cell transplant
What this could lead to
If it works, this approach could offer a path to long-term remission for adults whose AML did not respond to standard induction chemotherapy, a group with few good options.
What could go wrong
The trial is small and early-stage, so results may not hold up in larger studies. The treatment combines intensive chemotherapy with a donor stem cell transplant, which carries serious risks including infections, 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 2

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

Participants

26 people

The number who actually took part.

Start date

Jul 2010

Finished

Dec 2014

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 55 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: * Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leukemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease) * Age: 18-55 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. * Have adequate renal and hepatic functions as indicated by the following laboratory values: * Serum creatinine ≤1.0 mg/dL; if serum creatinine \>1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be \>60 mL/min/1.73 m² as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) * Serum bilirubin ≤1.5 mg/dL × upper limit of normal (ULN) * Aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 × ULN * Alkaline phosphatase ≤2.5 × ULN Exclusion Criteria: * Documented chloroma * Patients having AML M3 * Documented leukemic infiltration of CNS/cerebrospinal fluid * Karnofsky performance score below \< 60% * Acute or chronic heart failure * HIV infection, chronic viral hepatitis * Severe neurological or psychiatric disorders * Any circumstances that preclude the use of the drugs used within the protocol * Prior allogeneic or autologous stem cell transplantation * \> 3 courses of prior chemotherapy * Denied informed consent * Pregnancy or denied of effective contraceptive method

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

AML

Contacts and locations

Locations

  • CHRU de Strasbourg

    Strasbourg, France

  • CHRU lille

    Lille, France

  • CHU Caen

    Caen, France

  • CHU Toulouse

    Toulouse, France

  • CHU de Bordeaux

    Bordeaux, France

  • Hôpital Edouard Herriot

    Lyon, France

  • Institut Paoli Calmette

    Marseille, France

  • Nantes University hospital

    Nantes, 44200, France

  • Paris saint Louis

    Paris, France

More trials for these conditions

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