Status:
TERMINATED
Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
Up to 45 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell and donor natural killer cell transplant helps stop the growth of cancer and abnormal cells and help...
Detailed Description
OBJECTIVES: Primary * Determine the effect of haploidentical donor CD34+ purified peripheral blood stem cells and donor natural killer (NK) cells on the risk of developing grades III-IV acute graft-...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following life-threatening hematological malignancies:
- Acute lymphoblastic leukemia meeting 1 of the following criteria:
- Advanced beyond first remission
- In first remission with high-risk prognostic features, including any of the following:
- Philadelphia chromosome-positive disease
- Chromosome 11q23 abnormality
- Hypodiploid
- Failed to achieve first remission within 1 month after induction
- Acute myeloid leukemia (AML) meeting 1 of the following criteria:
- Advanced beyond first remission
- First remission with high-risk prognostic features, including any of the following:
- Chromosome 11q23 abnormality
- Chromosome del 7q
- Secondary AML
- Failed to achieve first remission within 1 month after induction
- Myelodysplastic syndromes with International Prognostic Score \> 1
- Chronic myelogenous leukemia in accelerated or blastic phase
- No active CNS disease
- No suitable HLA-matched related or unrelated donor available
- Haploidentical family member available as donor of partially HLA-matched peripheral blood stem cells
- Least degree of mismatch to HLA-A, B, C, DRB1, and DQB1
- No mismatch for a single HLA-A, B, C, DRB1, or DQB1 antigen
- Donor killer cell immunoglobulin-like receptor ligand group expression preferably different than patient
- PATIENT CHARACTERISTICS:
- LVEF ≥ 45%
- DLCO ≥ 60% of predicted
- AST and ALT ≤ 2 times upper limit of normal (ULN) (unless due to malignancy)
- Bilirubin ≤ 2 times ULN (unless due to malignancy)
- No life expectancy \< 6 months due to coexisting disease other than the malignancy
- No active infection (e.g., polymerase chain reaction \[PCR\] evidence for cytomegalovirus, human herpes virus 6, or invasive fungal infection)
- No prior infections without evidence of resolution by PCR or imaging studies within the past 2 months
- No hypersensitivity to murine antibodies
- No known HIV positivity
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No prior marrow transplantation with total body irradiation \> 400 cGy
- No concurrent therapies for seizure disorder
- No growth factors for 21 days after transplantation
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00450983
Start Date
December 1 2006
End Date
July 1 2010
Last Update
May 24 2017
Active Locations (2)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
2
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024