Status:
TERMINATED
Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation be...
Detailed Description
PRIMARY OBJECTIVES: I. Examine the 1 year disease free survival (DFS) rate of patients with maternal donors or sibling donors who share the maternal haplotype (maternal group) and compare them to pat...
Eligibility Criteria
Inclusion
- Any patient with a hematologic or oncologic diagnosis without morphological evidence of disease in which allogeneic HSCT is thought to be beneficial.
- Patients must have a related donor who is a two or more allele mismatch at the HLA-A; B; C; DR loci.
- Patients must have adequate organ function:
- LVEF (Left ventricular ejection fraction) of \>50%
- Diffusion Capacity for Carbon Monoxide (DLCO) \>50% of predicted corrected for hemoglobin
- Adequate liver function as defined by a serum bilirubin \<1.8, Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5X upper limit of normal
- Creatinine clearance of \> 60 ml/min
- Performance status \> 80% (TJU Karnofsky)
- Hematopoietic Comorbidity Index (HCT-CI) Score \< 5 Points
- Patients must be willing to use contraception if they have childbearing potential
- Able to give informed consent, or if decisionally impaired, have a legal next of kin or guardian that can give informed consent
Exclusion
- Performance status \< 80 % (TJU Karnofsky)
- HCT-CI Score \> 5 Points
- Combination of Performance status of \< 80% (TJU Karnofsky) and an HCT-CI of 4 points or more.
- HIV positive
- Active involvement of the central nervous system with malignancy
- Psychiatric disorder that would preclude patients from signing an informed consent
- Pregnancy
- Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder
- Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have an ATG level of \> 2 ugm/ml
- Patients who cannot receive cyclophosphamide
- Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Key Trial Info
Start Date :
May 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01871441
Start Date
May 17 2013
End Date
October 20 2016
Last Update
May 16 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107