Using cyclophosphamide for bone marrow transplants from unrelated donors
Use of Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies, a Prospective Randomized Controlled Trial
PHASE2; PHASE3 · Hospital Israelita Albert Einstein · NCT03818334
This study is testing if using cyclophosphamide can help people who get bone marrow transplants from unrelated donors live longer and have fewer complications.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Year to 75 Years |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein (other) |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT03818334 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of cyclophosphamide in improving survival rates and reducing complications in patients receiving bone marrow transplants from matched unrelated donors. A total of fifty participants will be enrolled, with thirty receiving cyclophosphamide and twenty receiving antihuman T-lymphocyte immune globulin (ATG). The primary focus is on overall survival, progression-free survival, and the incidence of acute and chronic graft-versus-host disease (GvHD). The study aims to provide insights into the best post-transplant care for patients with hematological malignancies.
Who should consider this trial
Good fit: Ideal candidates include men and women of any age with hematological malignancies who require a stem cell transplant from a matched unrelated donor.
Not a fit: Patients with acute leukemias not in complete response or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce complications for patients undergoing bone marrow transplants.
How similar studies have performed: Previous studies have shown promise with cyclophosphamide in similar transplant settings, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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) * Chemorefractory lymphoproliferative disease * Active uncontrolled infection * HCT-CI \> 3 * Severe organic disfunction (heart ejection fraction \< 45%, glomerular filtration rate \< 50 mL.hour, pulmonary DLCO \< 50%) * Previous allogeneic bone marrow transplantation * Contraindication to cyclophosphamide or ATG
Where this trial is running
São Paulo, São Paulo
- Hospita Israelita Albert Eintein — São Paulo, São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Andreza A Feitosa Ribeiro, PhD — Hospital Israelita Albert Einstein
- Study coordinator: Andreza A Feitosa Ribeiro
- Email: andreza.ribeiro@einstein.br
- Phone: +5511992512523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Marrow Transplant Complications, Graft Versus Host Disease, Infection Viral, Engraft Failure, Immunologic Suppression, Bone Marrow Transplantation, Hematological Malignancies, Post-Cy