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Softer chemo before stem cell transplant aims to save more blood cancer patients

NCT ID NCT00841724

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Researchers test a gentler conditioning regimen before allogeneic stem cell transplantation in adults with blood cancers. The goal is to see if this reduced-toxicity approach lowers the risk of death within the first year after transplant. Participants receive fludarabine, busulfan, and thymoglobuline before receiving donor stem cells. The trial also tracks complications and overall survival.

What this could mean

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

Active substance
A gentler chemotherapy and antibody combination (fludarabine, busulfan, and thymoglobuline) given before donor stem cell transplant
What this could lead to
If it works, this gentler preparation could make donor stem cell transplants safer and more tolerable for adults with blood cancers, potentially extending the option to those who cannot handle standard high-dose treatment.
What could go wrong
This is a Phase 2 trial with 82 participants, so results may not hold in larger studies. The regimen still carries risks of infection, graft-versus-host disease, and the transplant may fail to cure the cancer.

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

82 people

The number who actually took part.

Start date

Jan 2009

Finished

Jan 2012

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: * Patients affiliated to a social security reimbursement system * Adults (men or women) aged between 18 and 65 years * Negative test for pregnancy * ECOG 0-1 or Karnofsky Index ≥ 70% * Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted) * Life expectancy \> 6 months * Signed informed consent * Diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation Exclusion Criteria: * Pregnant woman or not willing to take effective contraception * Classical contra-indications to the allogeneic stem cell transplantation procedure * Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics * Patients aged \< 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen * An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection * History of uncontrolled psychiatric condition * Patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

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

Hematological malignancies

Contacts and locations

Locations

  • CHU de Bordeaux

    Pessac, 33604, France

  • CHU de Nantes

    Nantes, 44093, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

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