Combined Haploidentical-Cord Blood Transplantation for Adults and Children
NCT ID: NCT00943800
Last Updated: 2021-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2006-10-09
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Good Risks patients
For patients transplanted in remission.
Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
Fludarabine is given through the vein daily for 5 days. Melphalan is given through the vein daily for 2 days. ATG is given every day in the vein for four days.
Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
High Risk Patients eligible for radiation
Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
Fludarabine is given through the vein daily for 5 days. Thiotepa is given through the vein daily for 2 days. ATG is given through the vein every other day for 4 days. TBI is given twice a day for 3 days.
High Risk Patients not eligible for radiation
Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Fludarabine, Busulfan, and ATG
Fludarabine is given through the vein daily for 5 days. Busulfan is given through the vein daily for 4 days. ATG is given through the vein every other day for 4 days.
Interventions
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Fludarabine-Melphalan & Rabbit antithymocyte globulin (r-ATG)
Fludarabine is given through the vein daily for 5 days. Melphalan is given through the vein daily for 2 days. ATG is given every day in the vein for four days.
Stem Cell Transplant
Infusion of haploidentical donor, umbilical cord blood
Stem Cells Collections
Haploidentical cells will be T-cell depleted using the Miltenyi Clinimax device.
Fludarabine, Thiotepa, Antithymocyte globulin (ATG), and Total Body Irradiation (TBI)
Fludarabine is given through the vein daily for 5 days. Thiotepa is given through the vein daily for 2 days. ATG is given through the vein every other day for 4 days. TBI is given twice a day for 3 days.
Fludarabine, Busulfan, and ATG
Fludarabine is given through the vein daily for 5 days. Busulfan is given through the vein daily for 4 days. ATG is given through the vein every other day for 4 days.
Eligibility Criteria
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Inclusion Criteria
1. Relapsed or refractory acute leukemia (myeloid or lymphoid)
2. Acute leukemia in first remission at high-risk for recurrence
3. Chronic myelogenous leukemia in accelerated phase or blast-crisis
4. Chronic myelogenous leukemia in chronic phase
5. Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
6. Chronic lymphocytic leukemia, relapsed or with poor prognostic features
7. Multiple myeloma
8. Myelodysplastic syndrome
9. Chronic myeloproliferative disease
10. Hemoglobinopathies
11. Aplastic anemia
Exclusion Criteria
2. Life expectancy is severely limited by concomitant illness
3. Patients with severely decreased LVEF or impaired pulmonary function tests(PFT's)
4. Estimated Creatinine Clearance \<50 ml/min
5. Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal
6. Evidence of chronic active hepatitis or cirrhosis
7. HIV-positive
8. Patient is pregnant
9. Patient or guardian not able to sign informed consent
1 Year
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Hongtao Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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The University of Chicago
Chicago, Illinois, United States
Countries
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References
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Liu H, Rich ES, Godley L, Odenike O, Joseph L, Marino S, Kline J, Nguyen V, Cunningham J, Larson RA, del Cerro P, Schroeder L, Pape L, Stock W, Wickrema A, Artz AS, van Besien K. Reduced-intensity conditioning with combined haploidentical and cord blood transplantation results in rapid engraftment, low GVHD, and durable remissions. Blood. 2011 Dec 8;118(24):6438-45. doi: 10.1182/blood-2011-08-372508. Epub 2011 Oct 5.
van Besien K, Hari P, Zhang MJ, Liu HT, Stock W, Godley L, Odenike O, Larson R, Bishop M, Wickrema A, Gergis U, Mayer S, Shore T, Tsai S, Rhodes J, Cushing MM, Korman S, Artz A. Reduced intensity haplo plus single cord transplant compared to double cord transplant: improved engraftment and graft-versus-host disease-free, relapse-free survival. Haematologica. 2016 May;101(5):634-43. doi: 10.3324/haematol.2015.138594. Epub 2016 Feb 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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14736B
Identifier Type: -
Identifier Source: org_study_id
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