Status:
TERMINATED
Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 69 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It may also stop the patient's ...
Detailed Description
OBJECTIVES: Primary * To estimate the probability of survival at 1 year in patients with advanced hematological malignancies or other diseases treated with non-myeloablative unrelated donor umbilica...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of advanced hematologic malignancy or other disease not curable by conventional chemotherapy, including any of the following:
- Acute myeloid leukemia in complete remission (CR)\* (as defined by hematologic recovery, \< 5% blasts in the bone marrow by morphology, and a cellularity of \> 15%), meeting one of the following criteria:
- In first complete remission (CR1) AND has high-risk disease as evidenced by any of the following:
- Preceding myelodysplastic syndromes (MDS)
- High-risk cytogenetics (e.g., monosomy 5 or 7, or as defined by referring institution treatment protocol)
- Required \> 2 courses of therapy to obtain CR
- Erythroblastic or megakaryocytic leukemia
- In second CR (CR2) or beyond
- Acute lymphoblastic leukemia in CR\* (as defined by hematologic recovery, \< 5% blasts in the bone marrow by morphology, and a cellularity of \> 15%), meeting one of the following criteria:
- In CR1 AND has high-risk disease as evidenced by any of the following:
- t(9;22), t(1;19), t(4;11), or other MLL rearrangements
- Hyplodiploid
- Required \> 1 course of therapy to obtain CR
- Beyond CR2
- Chronic myelogenous leukemia (CML)
- All types are allowed (except refractory blast crisis CML)
- Patients in chronic phase CML must have failed or been intolerant to prior imatinib mesylate (Gleevec) or other tyrosine kinase inhibitors
- MDS
- Any subtype allowed (including refractory anemia \[RA\])
- Severe pancytopenia or complex cytogenetics
- Blasts must be \< 5% (if blasts are ≥ 5%, pre-transplant induction therapy is required to reduce blast count to \< 5%)
- Large cell lymphoma, Hodgkin lymphoma, or multiple myeloma, meeting one of the following criteria:
- Chemotherapy-sensitive disease that has failed prior therapy
- Patients with large cell lymphoma or Hodgkin lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky)
- Ineligible for an autologous stem cell transplant
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, or follicular lymphoma that has progressed after ≥ 2 prior therapies
- Patients with bulky disease should be considered for debulking chemotherapy prior to transplant
- Patients with refractory disease are eligible provided disease is non-bulky AND an estimated tumor doubling time is ≥ 1 month
- Lymphoplasmacytic lymphoma, mantle cell lymphoma, or prolymphocytic leukemia
- Chemotherapy-sensitive disease that was previously treated with initial therapy
- Patients with mantle cell lymphoma must not have progressive disease during salvage therapy (stable disease allowed provided it is non-bulky)
- Mycosis fungoides and Sezary syndrome
- Bone marrow failure syndromes, except for Fanconi anemia
- Myeloproliferative syndromes NOTE: \*Patients for whom adequate marrow/biopsy specimens can not be obtained to determine remission status by morphologic assessment must have fulfilled criteria of remission (\< 5% blasts by flow cytometry and recovery of peripheral blood counts with no circulating blasts)
- Ineligible for autologous stem cell transplant due to any of the following:
- Prior autologous stem cell transplant
- Inadequate autologous stem cell harvest
- Inability to withstand a myeloablative preparative regimen
- Clinically aggressive/high-risk disease
- No evidence of progressive disease by imaging modalities or biopsy (persistent PET scan activity allowed provided there are no CT scan changes indicating progression)
- Acute leukemia that is refractory, persistent, or relapsed (defined as \> 5% blasts in normocellular bone marrow) allowed provided patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy
- Patients with stable disease are eligible provided the largest residual nodal mass is approximately \< 5 cm (largest residual mass must represent a 50% reduction and be approximately \< 7.5 cm for patients who have responded to prior therapy)
- No active CNS malignancy
- Umbilical cord blood (UCB) donor available
- UCB graft matched at 4/6 HLA-A, -B, and -DRB1 antigens with the recipient
- May include 0-2 antigen mismatches at the A, B, or DRB1 loci
- Unit selection based on cryopreserved nucleated cell dose and HLA-A, -B, and -DRB1 using intermediate resolution A, B antigen and DRB1 allele typing
- If 2 UCB units are required to reach the target cell dose, each unit must be a 3/6 HLA-A, -B, and -DRB1 antigen match to each other, as well as a 4/6 antigen match to the recipient
- No 5-6/6 HLA-A, -B, and -DRB1 matched sibling donor available
- PATIENT CHARACTERISTICS:
- Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100%
- Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance \> 40 mL/min (pediatrics)
- Adult patients with a creatinine \> 1.2 mg/dL or a history of renal dysfunction must have an estimated creatinine clearance of \> 40 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- LVEF ≥ 35%
- DLCO \> 30% predicted
- No requirement for O\_2
- No decompensated congestive heart failure
- No uncontrolled arrhythmia
- None of the following liver diseases or conditions:
- Fulminant liver failure
- Cirrhosis with evidence of portal hypertension or bridging fibrosis
- Alcoholic hepatitis
- Esophageal varices
- History of bleeding esophageal varices, hepatic encephalopathy, or correctable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time
- Ascites related to portal hypertension
- Bacterial or fungal abscess
- Biliary obstruction
- Chronic viral hepatitis with total serum bilirubin \> 3 mg/dL
- Symptomatic biliary disease
- Recent mold infection (e.g., Aspergillus) allowed provided patient received ≥ 30 days of appropriate treatment AND infection is controlled and cleared by Infectious Disease
- No evidence of HIV infection or known HIV-positive serology
- No uncontrolled viral or bacterial infection
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 months since prior myeloablative stem cell transplantation
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00719849
Start Date
November 1 2005
End Date
December 1 2009
Last Update
June 14 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109