Status:
COMPLETED
Reduced Intensity Haploidentical Transplant for Hematological Malignancies
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Many patients with hematological malignancies (leukemia, lymphoma, multiple myeloma) cannot undergo hematopoietic stem cell transplantation (HSCT) because they do not have a well matched donor. HSCT f...
Detailed Description
Haploidentical hematopoietic stem cell transplant is a life saving therapy for patients who are without well matched donors. This type of therapy has been associated with poor outcomes in the past due...
Eligibility Criteria
Inclusion
- Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied.
- Patients must have a related donor who is a two or more allele mismatch at the HLA-A;B; C; DR loci.
- Patients who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol.
- Patients must adequate organ function:
- LVEF of \>45%
- DLCO \>45% of predicted corrected for hemoglobin
- Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal
- Serum creatinine \< 2.0 mg/dl or creatinine clearance of \> 40 ml/min
- Performance status \> 70% (Karnofsky)
- Patients must be willing to use contraception if they have childbearing potential
- Able to give informed consent
Exclusion
- Performance status of \< 70% (Karnofsky)
- 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 or complications there from.
- Patients who have received alemtuzumab within 8 weeks of transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin and have ATG levels of \> 2 µgm/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 :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01162096
Start Date
September 1 2006
End Date
April 1 2012
Last Update
April 30 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107