Status:
COMPLETED
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Hematopoietic/Lymphoid Cancer
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant help...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (DFS) at 12 months at our institution....
Eligibility Criteria
Inclusion
- Diagnosis of a hematological malignancy requiring an allogeneic stem cell transplant consistent with the standard of care
- Remission of any acute hematologic malignancy or adequate disease control for chronic malignancies.
- Ages 18-69 years old.
- Available familial haploidentical (4 to 6 out of 8 HLA loci-matched) donor
Exclusion
- Significant organ dysfunction defined as: LV EF \< 50% (evaluated by echocardiogram or MRI), DLCO or FEV1 \< 65% predicted, AST/ALT \> 2.5 x ULN, Bilirubin \> 1.5 x ULN, Serum creatinine \> 2mg/dL, dialysis, or prior renal transplant
- HIV positive (Recipients who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV-I/II) are not excluded from participation)
- Positive pregnancy test for women of childbearing age.
- Major anticipated illness or organ failure incompatible with survival form transplant.
- Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.
Key Trial Info
Start Date :
February 25 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02248597
Start Date
February 25 2015
End Date
January 18 2023
Last Update
October 11 2023
Active Locations (1)
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1
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157