Status:
RECRUITING
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib
Lead Sponsor:
Henry Ford Health System
Conditions:
Hematological Malignancy
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , ...
Eligibility Criteria
Inclusion
- 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified
- Candidate for stem cell transplant in a malignant hematological condition
- Karnofsky Performance Scale 0-1
- Available donor able to undergo a Peripheral blood stem cells collection
- Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults.
- Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula)
- Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin.
- Left ventricle ejection fraction \> 40%.
- Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.
Exclusion
- Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation
- HIV positive; active hepatitis B or C
- Patients with active uncontrolled infections.
- Liver cirrhosis
- Uncontrolled central nervous system involvement by tumor cells
- Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Inability to comply with medical therapy or follow-up
Key Trial Info
Start Date :
March 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03850366
Start Date
March 8 2016
End Date
January 1 2027
Last Update
February 11 2025
Active Locations (1)
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1
Henry Ford hospital
Detroit, Michigan, United States, 48202