Could less chemo be better after stem cell transplants?
NCT ID NCT07193420
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether a lower dose of the chemotherapy drug cyclophosphamide can reduce side effects after a half-matched stem cell transplant for blood cancers. The standard dose often causes complications, so researchers want to see if a lower dose works just as well. The study will follow 180 adults for two years to compare survival, relapse rates, and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cyclophosphamide (a chemotherapy drug)
- What this could lead to
- If successful, a lower dose of cyclophosphamide could reduce side effects and improve survival without severe complications after stem cell transplants.
- What could go wrong
- This is an early-stage trial with only 180 participants, so results may not apply to everyone. Lowering the dose might also reduce its effectiveness in preventing 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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 years * Confirmed hematological malignancy with an indication for allogeneic HSCT * Presence of a haploidentical donor willing to donate PBSC * Patient planned to receive a thiotepa-based conditioning regimen * Provision of written informed consent Affiliation to a social security system (excluding "Aide Médicale d'État") Exclusion Criteria: * Karnofsky performance status \< 70% * Life expectancy \< 1 month, as determined by the attending physician * Acute or chronic heart failure, defined as left ventricular ejection fraction \< 40% * Pulmonary dysfunction with diffusion capacity \< 50% of predicted values * Renal impairment with estimated glomerular filtration rate (eGFR) \< 45 mL/min (calculated using the CKD-EPI formula) * Decompensated hemolytic anemia * Fanconi anemia and other DNA breakage repair disorders * Acute urothelial toxicity due to cytotoxic chemotherapy or radiotherapy * Obstruction of urinary outflow * Concomitant use with yellow fever vaccine and with live virus and bacterial vaccines * Combination with products containing Hypericum perforatum * Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein (P-gp) or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and/or life-threatening events, e.g., bosentan, dabigatran etexilate and aliskiren * Active non-controlled infectious disease * Positive HIV status * Pregnancy, breast-feeding, or refusal to use effective contraception for the duration of the study and 6 months after the last treatment dose * Individuals under legal protection measures or unable to provide consent (e.g., severe neurological or psychiatric disorders, or deprivation of liberty by judicial or administrative decision) * Hypersensitivity to the active substance or any of the excipients * Concurrent participation in another investigational therapeutic study * Inability to comply with study procedures as assessed by the investigator based on objective criteria, including but not limited to: * Significant language barrier in the absence of adequate translation support * Social or geographic situation preventing follow-up and adherence to visit schedule * Ongoing substance abuse likely to interfere with protocol compliance * Documented cognitive or functional impairment not otherwise covered under legal protection
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Saint Antoine Hospital - Hematology Department
Paris, 75012, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can we predict lung damage from CAR t-cell therapy?
- Switching stomach drugs after transplant may tame a deadly immune attack
- Can a biologic calm the lungs after stem cell transplant?
- Can a new drug combo reset the immune system to beat relapsed leukemia?