Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
Recruiting
Phase 2
Phase 3
Interventional Study
Bone Marrow Transplant Complications
Graft Versus Host Disease
Infection Viral
Engraft Failure
Immunologic Suppression
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 75
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 50 (estimated)
- Sponsor
- Hospital Israelita Albert Einstein · Other
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About This Trial
This study aims to evaluate the clinical efficacy of cyclophosphamide in patients receiving a bone marrow graft from a matched unrelated donor in overall survival, progression free survival and cumulative incidence of acute and chronic GvHD. Thirty patients will receive cyclophosphamide while twenty patients will receive antihuman T-lymphocyte immune globulin (ATG).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Men and Women of Any Age
* Indication for an HSCT without matched sibling donor
* Have a matched unrelated donor (HLA 10 x 10 or 9 x 10)
* Hematological malignancy
Exclusion Criteria:
* Acute leukemias not in complete response (that is \> 5% blast in the bone marrow)
* Chemo…
Contacts