Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2010-04-30
2012-06-30
Brief Summary
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Detailed Description
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\- To assess the rate of engraftment with combined haploidentical-cord blood transplantation in patients with pre-existing donor specific anti-HLA antibodies and in those with active disease
Secondary Objectives
* To determine the long term fate of the haplo transplant and the cord blood transplant in this setting.
* To describe the incidence and severity of acute and chronic GVHD.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conditioning Regimen I
Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)
Melphalan
Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine
Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG)
ATG is given every other day for 4 days.
Conditioning Regimen II
Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).
Fludarabine
Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG)
ATG is given every other day for 4 days.
Busulfan
Busulfan is given daily for 4 days.
Total Body Irradiation (TBI)
TBI is given twice on the last day.
Interventions
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Melphalan
Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
Fludarabine
Fludarabine is given through the vein daily for 5 days.
Antithymocyte Globulin (ATG)
ATG is given every other day for 4 days.
Busulfan
Busulfan is given daily for 4 days.
Total Body Irradiation (TBI)
TBI is given twice on the last day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute leukemia in first remission at high-risk for recurrence
* Chronic myelogenous leukemia in accelerated phase or blast-crisis
* Chronic myelogenous leukemia in chronic phase
* Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
* Chronic lymphocytic leukemia, relapsed or with poor prognostic features
* Multiple myeloma
* Myelodysplastic syndrome
* Chronic myeloproliferative disease
* Hemoglobinopathies
* Aplastic anemia
Exclusion Criteria
* Life expectancy is severely limited by concomitant illness
* Patients with severely decreased LVEF or impaired pulmonary function tests
* Estimated Creatinine Clearance \<50 ml/min
* Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal
* Evidence of chronic active hepatitis or cirrhosis
* HIV-positive
* Patient is pregnant
* Patient or guardian not able to sign informed consent
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Andrew Artz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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10-020-B
Identifier Type: -
Identifier Source: org_study_id
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