Post Transplant Cyclophosphamide in Matched Unrelated Donor Stem Cell Transplantation for Hematological Malignancies

Launched by HOSPITAL ISRAELITA ALBERT EINSTEIN · Jan 24, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called cyclophosphamide in patients who are receiving a bone marrow transplant from a matched unrelated donor to treat blood cancers, such as leukemia or lymphoma. The main goal is to see if cyclophosphamide can help improve survival rates and reduce the risk of complications like graft-versus-host disease (a condition where the donated cells attack the patient’s body) and infections. In this trial, 30 participants will receive cyclophosphamide, while 20 will receive a different treatment called antihuman T-lymphocyte immune globulin (ATG).

To be eligible for this trial, participants can be men or women of any age who need a stem cell transplant and have a matched unrelated donor. However, they cannot have active leukemia that is not in complete remission, severe organ dysfunction, or certain other medical conditions. Participants in this trial can expect close monitoring and care throughout the process, and they will contribute to important research that could improve future treatments for patients undergoing similar transplants.

Gender

ALL

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