Status:
COMPLETED
A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a parti...
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 either a one, two or three out of six antigen mismatch at the HLA-A;B;DR loci.
- Patients without a well-matched unrelated donor or those who have a disease status that precludes a wait for an identified unrelated donor.
- Patients must adequate organ function:
- LVEF of \>45%
- FVC or FEV1 \>45% of predicted
- 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 \> 60% (Karnofsky)
- Patients must be willing to use contraception if they have childbearing potential
- Able to give informed consent
Exclusion
- An eligible HLA-identical sibling donor.
- Performance status \< 60% (Karnosfsky)
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00429143
Start Date
January 1 2006
End Date
June 1 2010
Last Update
May 4 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107