Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor
NCT ID: NCT01598025
Last Updated: 2018-08-09
Study Results
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View full resultsBasic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2012-05-02
2017-10-16
Brief Summary
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This study is being done to test the safety and the treatment results of a specific kind of transplant. In this transplant, blood from two donors will be used. Each donor will share one half of your HLA type. Blood from both donors will be transplanted at the same time.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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REGIMEN 1
REGIMEN 1: Patients undergo hyperfractionated TBI TID for a total of 11-12 doses on days -10 to -7 and receive thiotepa IV over 4 hours QD on days -6 and -5, fludarabine phosphate IV over 30 minutes QD on days -6 to -2, and anti-thymocyte globulin IV on days -4 to -2.
TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.
total-body irradiation (TBI)
thiotepa
fludarabine phosphate
anti-thymocyte globulin
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
laboratory biomarker analysis
Regimen 2
To be given to patients non-malignant, life-threatening diseases and patients with hematologic malignancies, with extensive prior therapy and comorbidities who are unable to receive TBI, consists of Melphalan 70mg/m2 IV x 2 days, thiotepa 5mg/kg IV x 2 days (or 10mg/kg x 1 day), and fludarabine 25 mg/m2 IV x 5 days.
TRANSPLANTATION: Patients undergo CD34-selected allogeneic PBSCT on day 0.
thiotepa
fludarabine phosphate
melphalan
anti-thymocyte globulin
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
laboratory biomarker analysis
Interventions
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total-body irradiation (TBI)
thiotepa
fludarabine phosphate
melphalan
anti-thymocyte globulin
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
AML in 1st remission - for patients whose AML does not have 'good risk' cytogenetic features (i.e. t 8;21, t15;17, inv 16).
* Secondary AML in 1st remission
* AML in 1st relapse or \> 2nd remission
* ALL/LL in 1st remission clinical or molecular features indicating a high risk for relapse; or ALL \> 2nd remission
* CML failing to respond to or not tolerating Imatinib, dasatinib, or nilotinib in first chronic phase of disease; or CML in accelerated phase or second chronic phase.
* Non-Hodgkins lymphoma with chemoresponsive disease in any of the following categories: a) intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants.
* any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant. Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or transfusion dependence, RAEB-1 and RAEB-2 and Acute myelogenous leukemia (AML) evolved from MDS, who are not eligible for transplantation under protocol IRB 08-008.
* Chronic myelomonocytic leukemia: CMML-1 and CMML-2.
* Other rare lethal disorders of Hematopoiesis and Lymphopoiesis for which a T-cell depleted transplant is indicated (e.g. hemophagocytic lymphohistiocytosis; refractory aplastic anemia or conjugated cytopenias; non-SCID lethal genetic immunodeficiencies such as Wiskott Aldrich Syndrome, CD40 ligand deficiency, ALPS).
* Patients may be of either gender and of any racial or ethnic background.
* Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status \> 70%.
* Patients must have adequate organ function measured by:
Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50% and must improve with exercise.
* Hepatic: \< 3x ULN ALT and \< 2.0x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
* Renal: serum creatinine \<1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 40 ml/min (measured or calculated/estimated)
* Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
* Each patient must be willing to participate as a research subject and must sign an informed consent form.
* Each donor must meet criteria outlined by institutional policies
* Donor must have adequate peripheral venous catheter access for leukapheresis or must agree to placement of a central catheter.
Exclusion Criteria
* Uncontrolled viral, bacterial or fungal infection
* Patient seropositive for HIV-I/II; HTLV -I/II
* Presence of leukemia in the CNS.
* Evidence of active infection (including urinary tract infection, or upper respiratory tract infection), viral hepatitis exposure (on screening), unless only HBS Ab+ and HBV DNA negative, or serologic evidence of exposure or infection with HIV-I/II or HTLV-I/II
* If donors do not meet institutional guidelines, exclusion will be considered.
19 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Richard O'Reilly, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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12-053
Identifier Type: -
Identifier Source: org_study_id
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