Lowering the total dose of cyclophosphamide after haploidentical stem cell transplant for blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, open-label, randomized trial compares reducing the post-transplant cyclophosphamide dose from 100 mg/kg to 70 mg/kg in patients receiving haploidentical hematopoietic stem cell transplantation for hematologic malignancies. The primary endpoint is GREFS at 2 years, a composite measure of survival without severe GVHD, disease relapse/progression, or cyclophosphamide-related adverse events. Participants are adults with a hematologic malignancy, a haploidentical donor, and a thiotepa-based conditioning regimen. Cyclophosphamide is given at either 35 mg/kg/day or 50 mg/kg/day as part of the regimen.

Why it matters

Who can join: the full rules

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

Where it's running

• Saint Antoine Hospital - Hematology Department
  Paris, France Recruiting

Study contacts

• Principal investigator: Mohamad MOHTY, PU-PH — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Mohamad MOHTY, PU-PH
• Email: mohamad.mohty@inserm.fr
• Phone: 00 33 1.49.28.26.20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.