Status:
UNKNOWN
Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation
Lead Sponsor:
Sheba Medical Center
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Investigators hypothesize that combination of ATLG with PTCy in matched or mismatched unrelated hematopoietic stem cell transplantation will reduce acute and chronic GVHD incidence. Furthermore it wil...
Eligibility Criteria
Inclusion
- Patients with MDS/AML
- 18 years or older and willing and able to comply with the protocol requirements.
- LVEF ≥ 40%. 2-D transthoracic echocardiogram (ECHO) is the preferred method of evaluation. Multigated Acquisition Scan (MUGA) is acceptable if ECHO is not available.
- Patients undergoing 8-10/10 HLA matched unrelated and unmanipulated PBSC transplantation
- Patients conditioned with reduced intensity or reduced toxicity conditioning of fludarabine with reduced dose (2 days) or myeloabalative doses (4 days) of busulfan or with treosulfan.
- Patients must sign written informed consent.
- Adequate birth control in fertile patients.
Exclusion
- Patients undergoing other type of transplantation or with other type of basic disease other than AML or MDS.
- Patients with respiratory failure (DLCO \< 30%).
- Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention.
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
- Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
- Creatinine \> 2.0 mg/dl
- ECOG-Performance status \> 2
- Uncontrolled infection
- Pregnancy or lactation
- CNS disease involvement
- Pleural effusion or ascites \> 1 liter.
Key Trial Info
Start Date :
September 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03357159
Start Date
September 6 2018
End Date
December 1 2024
Last Update
November 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chaim Sheba Medical Center
Ramat Gan, Israel, 57261