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Study of Reduced Cyclophosphamide Dose After Haploidentical Stem Cell Transplantation in Patients with Blood Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial evaluates the effectiveness of reduced dosing of cyclophosphamide (a medication) after haploidentical hematopoietic stem cell transplantation (a procedure where blood-forming stem cells from a partially matched donor are transferred to a patient) for treating hematological malignancies (blood cancers). The purpose of the study is to determine if lowering the dose of post-transplant cyclophosphamide from the standard 100 mg/kg to 70 mg/kg will be equally effective while potentially reducing side effects.

The study involves patients who have blood cancers and require a stem cell transplant from a family member who is a partial match (haploidentical donor). All participants will receive a thiotepa-based conditioning regimen (preparatory treatment) before the transplant. After the transplant, patients will be randomly assigned to receive either the standard or reduced dose of cyclophosphamide, which helps prevent rejection of the donor cells and reduces the risk of graft-versus-host disease (a condition where donor cells attack the recipient's body).

Participants will be monitored for two years after transplantation to assess survival, cancer relapse, treatment side effects, and quality of life. The researchers will evaluate whether the reduced dose of cyclophosphamide provides similar benefits to the standard dose while potentially causing fewer complications.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Randomization

    After providing written informed consent, you will be enrolled in the REDUCy study for patients with hematological malignancies (blood cancers) who need a haploidentical hematopoietic stem cell transplantation (a transplant using stem cells from a partially matched family donor).

    You will be randomly assigned to receive either the standard dose of post-transplant cyclophosphamide (100 mg/kg) or the reduced dose (70 mg/kg). Cyclophosphamide is a medication that helps prevent rejection of the transplant.

  2. Step 2

    Baseline Assessments

    Before the transplant procedure, your medical team will conduct baseline assessments including quality of life questionnaires (FACT-BMT and EQ-5D-5L) to compare with future measurements.

  3. Step 3

    Conditioning Regimen

    You will receive a thiotepa-based conditioning regimen. This is a combination of medications that prepare your body for the stem cell transplant by clearing space in your bone marrow for the new cells.

  4. Step 4

    Transplantation

    You will receive peripheral blood stem cells (PBSC) from your haploidentical donor (a family member who is a partial match).

    This procedure is similar to receiving a blood transfusion and is typically not painful.

  5. Step 5

    Post-Transplant Cyclophosphamide

    After the transplantation, you will receive cyclophosphamide according to your assigned group:

    - Standard dose group: You will receive a total of 100 mg/kg of cyclophosphamide

    - Reduced dose group: You will receive a total of 70 mg/kg of cyclophosphamide

    This medication helps prevent graft-versus-host disease (GVHD), a condition where the donated cells attack your body's tissues.

  6. Step 6

    Recovery and Monitoring

    Your medical team will monitor your recovery, particularly looking at neutrophil recovery (when your white blood cell count returns to safer levels) and platelet recovery (when your platelet count returns to safer levels).

    They will also monitor for any signs of infection (bacterial, viral, or fungal) or organ damage.

  7. Step 7

    Follow-up Assessments

    You will have regular follow-up assessments for two years after your transplant, including:

    - Quality of life assessments at 1, 3, 6, 12, and 24 months using questionnaires

    - Monitoring for acute GVHD (occurs within the first 180 days after transplant)

    - Monitoring for chronic GVHD (can occur up to 2 years after transplant)

    - Checking for signs of relapse or progression of your original blood cancer

    - Assessment of any side effects from the cyclophosphamide treatment

  8. Step 8

    Final Study Assessment

    At the two-year mark after your transplant, the research team will conduct a final assessment to evaluate the GREFS (GVHD-free, relapse-free, event-free survival).

    This is a combined measure that looks at whether you have survived without experiencing severe GVHD, cancer relapse, or serious side effects from the cyclophosphamide.

Who can join the trial?

6 criteria

  • Age 18 years or older
  • Have a confirmed hematological malignancy (blood cancer) that requires a stem cell transplant
  • Have a haploidentical donor (partially matched family member) who is willing to donate peripheral blood stem cells (PBSC)
  • Be scheduled to receive a treatment plan that includes a drug called thiotepa before the transplant
  • Be able to provide written informed consent
  • Be affiliated with a French social security system (excluding "Aide Médicale d'État")

Who cannot join the trial?

12 criteria

  • Not being at least an adult (18 years or older)
  • Not having a hematological malignancy (blood cancer such as leukemia, lymphoma, or multiple myeloma)
  • Not being a candidate for haploidentical HSCT (a type of stem cell transplant from a partially matched family donor)
  • Not being treated at one of the 16 French centers participating in the study
  • Inability to provide informed consent
  • Pregnancy or breastfeeding
  • Having a medical condition that makes participation unsafe
  • Having received previous stem cell transplantation that failed
  • Having active, uncontrolled infection
  • Having severe organ dysfunction that would prevent safe transplantation
  • Currently participating in another clinical trial that could interfere with this study
  • Not being able to follow study procedures or attend follow-up appointments
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Investigated drugs

Post-transplant cyclophosphamide (PTCy) is a medication used after a hematopoietic stem cell transplantation (bone marrow transplant) to help prevent complications. It works by suppressing the immune system to reduce the risk of graft-versus-host disease, a condition where the donated cells attack the recipient's body. In this study, researchers are testing whether a reduced dose of this medication can be as effective as the standard dose while potentially causing fewer side effects.

What is already known about the treatment

Cyclophosphamide – An intravenously administered chemotherapy medication commonly used after haploidentical hematopoietic stem cell transplantation (HSCT) to prevent graft-versus-host disease. It belongs to the alkylating agent class of drugs and works by damaging the DNA of rapidly dividing cells, particularly affecting immune cells that could attack the recipient's tissues. In transplant settings, cyclophosphamide helps eliminate potentially harmful donor T cells while sparing stem cells, thus preventing rejection while allowing successful engraftment. The standard post-transplant dose is typically 100 mg/kg, though this clinical trial is investigating whether a reduced dose of 70 mg/kg might be equally effective while potentially reducing side effects.

Investigated diseases

  • Hematological Malignancies

    A diverse group of cancers that affect the blood, bone marrow, and lymphatic system. These disorders originate from abnormal blood cells or their precursors, disrupting normal blood cell production and function. The progression varies by specific type but generally involves uncontrolled proliferation of abnormal blood cells that crowd out healthy cells. As the disease advances, patients may experience decreased production of normal blood cells, leading to anemia, increased bleeding risk, and compromised immune function. Hematological malignancies include leukemias, lymphomas, multiple myeloma, and myelodysplastic syndromes.

  • Graft-versus-Host Disease (GVHD)

    A complication that occurs after hematopoietic stem cell transplantation when donor immune cells (the graft) recognize the recipient's tissues (the host) as foreign and attack them. Acute GVHD typically develops within 100 days of transplantation and primarily affects the skin, liver, and gastrointestinal tract. Chronic GVHD usually occurs after 100 days post-transplant and can affect numerous organs including the skin, mouth, eyes, liver, lungs, and joints. The severity of GVHD ranges from mild to severe, with symptoms corresponding to the affected organs and tissues.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519986-23-00Estimated enrolment180 patientsSponsorAssistance Publique Hopitaux De Paris

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