Status:
COMPLETED
Haploidentical Stem Cell Transplantation for Patients With Hematologic Malignancies
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Leukemia, Acute Lymphocytic (ALL)
Leukemia, Myeloid, Acute(AML)
Eligibility:
All Genders
2-21 years
Phase:
PHASE3
Brief Summary
Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling...
Detailed Description
Secondary outcome evaluations for this clinical study include the following: * To estimate overall survival, disease free survival and event free survival for these patients * To estimate the inciden...
Eligibility Criteria
Inclusion
- Lacking a HLA-identical sibling or unrelated donor matched at 6 HLA loci formally requested within an approximate 90 day period from search initiation and who has a mismatched family member donor available
- At least 2 and less than or equal to 21 years of age
- Must have one of the following diagnosis:
- Acute lymphoid leukemia (ALL) in second, third, or subsequent remission.
- ALL in first remission but high risk for relapse.
- Acute myeloid leukemia (AML) in relapse or remission.
- Secondary AML / MDS
- Chronic myeloid leukemia (CML)
- Juvenile myelomonocytic leukemia (JMML).
- Myelodysplastic syndrome (MDS).
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Non-Hodgkin lymphoma in second or subsequent CR
- Patients with a shortening fraction ≥ 25%
- Patients with a creatinine clearance ≥ 40cc/min/1.73m\^2
- Patients with FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air
- Patients with direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L
- Patients with a Karnofsky or Lansky (age dependent) performance score of ≥ 70
- Mismatched family member donor is available, HIV negative and ≥ 18 years of age
Exclusion
- Patients who have received a previous hematopoietic stem cell allograft
- Patients with a known allergy to rabbit or murine products
- Patients with isolated CNS, testicular or other isolated extramedullary site of relapse
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00186823
Start Date
March 1 2002
End Date
January 1 2009
Last Update
January 29 2009
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105