Status:
TERMINATED
Donor Stem Cell Transplant Followed By Donor White Blood Cell Infusions in Treating Young Patients With Hematologic Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. Wh...
Detailed Description
OBJECTIVES: * Determine the feasibility of allogeneic hematopoietic stem cell transplantation using a reduced-intensity conditioning regimen, in terms of whole blood engraftment rate at 100 days post...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of one of the following hematopoietic malignancies:
- Acute lymphoblastic leukemia or myeloid leukemia with \< 30% blasts in the bone marrow
- Juvenile myelomonocytic leukemia
- Chronic myelogenous leukemia in chronic or accelerated phase
- Relapsed non-Hodgkin's or Hodgkin's lymphoma in at least partial remission
- Considered at high risk (\> 30%) of toxic death with standard hematopoietic stem cell transplantation (HSCT), as indicated by at least one of the following:
- Creatinine \> 1.5 times normal OR creatinine clearance \< 70 mL/min OR tubular damage that is not corrected by cessation of chemotherapy
- DLCO \< 60% of predicted OR history of prior intubation due to lung disease (intubation for surgery excluded)
- Shortening fraction \< 30%
- History of disseminated fungal infection during chemotherapy OR currently receiving antifungal agents OR history of ≥ 2 septic episodes (confirmed by cultures) that required ICU support
- Patients with improving fungal or other infections eligible
- Improving infection is defined as confirmed negative cultures on 2 separate occasions, at least 1 week apart, and/or stable or improving imaging studies (e.g., CT scan) of the infected site
- Two imaging studies taken at least 2 weeks apart must show stable or improved disease
- History of stroke or abnormal MRI/MRA OR leukoencephalopathy OR seizures that are not fully controlled with anticonvulsants (\> 2 episodes of seizures in the preceding year or 1 episode of status epilepticus in a patient who is receiving anticonvulsant therapy)
- History of prior significant bleeding (e.g., pulmonary, CNS, or gastrointestinal) OR history of a clotting disorder as manifested by prior significant thromboses (e.g., superior vena cava, inferior vena cava, or femoral vein)
- Failed conventional therapies and not eligible for myeloablative protocols
- May have failed prior conventional HSCT
- No active CNS leukemia
- Unrelated or related donor available, meeting the following criteria:
- Matched for at least 7/8 loci by high-resolution typing
- One mismatch at A, B, or C loci allowed
- Fully matched at DRB1 locus
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- No active/progressing viral, bacterial, protozoal, or fungal infection
- Transaminases ≤ 5 times normal (except in the presence of autoimmune liver disease)
- Shortening fraction ≥ 25%
- DLCO ≥ 40% OR pulse oximetry ≥ 85% on room air
- Glomerular filtration rate ≥ 40 mL/min
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior prolonged intensive chemotherapy (\> 3 years of therapy or ≥ 3 different chemotherapeutic protocols) allowed
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00301860
Start Date
January 1 2003
End Date
November 1 2007
Last Update
July 15 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115