NCT03818334 Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies
| NCT ID | NCT03818334 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Hospital Israelita Albert Einstein |
| Condition | Bone Marrow Transplant Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2018-11-06 |
| Primary Completion | 2021-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2018-11-06 with a primary completion date of 2021-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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) * 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
Contact & Investigator
Andreza A Feitosa Ribeiro, PhD
PRINCIPAL INVESTIGATOR
Hospital Israelita Albert Einstein
Frequently Asked Questions
Who can join the NCT03818334 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 75 Years, studying Bone Marrow Transplant Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03818334 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03818334 currently recruiting?
Yes, NCT03818334 is actively recruiting participants. Contact the research team at andreza.ribeiro@einstein.br for enrollment information.
Where is the NCT03818334 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT03818334 clinical trial?
NCT03818334 is sponsored by Hospital Israelita Albert Einstein. The principal investigator is Andreza A Feitosa Ribeiro, PhD at Hospital Israelita Albert Einstein. The trial plans to enroll 50 participants.