Status:
TERMINATED
Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
12-45 years
Phase:
PHASE1
PHASE2
Brief Summary
Rationale: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system f...
Detailed Description
Objectives: Primary * Determine the safety, in terms of infusional toxicity, of myeloablative unrelated donor double-unit umbilical cord blood (UCB) transplantation via intra-bone marrow injection (...
Eligibility Criteria
Inclusion
- Acute myeloid leukemia (AML): high risk CR1
- Acute lymphocytic leukemia (ALL): high risk CR1 \[t(9;22), t (1:19), t(4;11) or other MLL rearrangements\] or \> 1 cycle to obtain CR; CR2+. All patients must be in CR as defined by hematological recovery, AND \<5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
- Chronic myelogenous leukemia (CML) excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.
- Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics.
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma that have progressed after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm).
- Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+.
- Large cell NHL \> CR2/\> PR2. Patients in CR2/PR2 with initial short remission (\<6 months) are eligible.
- Lymphoblastic lymphoma.
- Multiple myeloma beyond PR2.
- Karnofsky performance status (PS) 90-100% (adults)
- Lansky PS 50-100% (children)
- Acceptable organ function
Exclusion
- Active infection at time of transplantation
- History of HIV infection
- Pregnant or breast feeding.
- Chemotherapy refractory large cell and high grade NHL (ie progressive disease after \> 2 salvage regimens)
- Extensive prior therapy including \> 12 months alkylator therapy or \> 6 months alkylator therapy with extensive radiation.
- Diffuse myelofibrosis of BM (bone marrow) (any severity) regardless of primary diagnosis (focal fibrosis acceptable provided it involves \< 20% of BM volume).
- History of pelvic irradiation.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00295880
Start Date
June 1 2005
End Date
August 1 2008
Last Update
December 28 2017
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