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Allo HSCT Using RIC for Hematological Diseases

Descriptive Information
Brief Title † Allo HSCT Using RIC for Hematological Diseases
Official Title † Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) for the Treatment of Hematological Diseases [MT2015-32]
Brief Summary This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion. The primary objective is to evaluate rates of acute graft-versus-host disease (GVHD) grades II-IV and chronic GVHD with an updated GVHD prophylaxis of tacrolimus and mycophenolate mofetil (MMF) with a non-myeloablative preparative regimen in persons with hematologic malignancies.
Detailed Description
Study Phase Phase 2
Study Type † Interventional
Study Design †
Primary Outcome Measure † Evaluate rates of acute graft-versus-host disease (GVHD) II-IV
Secondary Outcome Measure † Evaluate rates of chronic GVHD
Condition † Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Plasma Cell Leukemia Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma B-Cell Lymphoma Follicular Lymphoma Lymphoplasmacytic Lymphoma Mantle-Cell Lymphoma Prolymphocytic Leukemia Lymphoblastic Lymphoma Burkitt's Lymphoma Non-Hodgkin's Lymphoma Multiple Myeloma Myeloproliferative Syndromes Hematological Diseases
Intervention † DrugAllopurinol
Study Arms / Comparison Groups Reduced Intensity Conditioning Non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related or unrelated donor stem cell infusion
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 124
Start Date † March 9, 2017
Completion Date March 2023
Primary Completion Date March 2023
Eligibility Criteria † Inclusion Criteria: - Age, Performance Status, and Graft Criteria - Age 0 to 70 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 ( 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for de-bulking chemotherapy before transplant. - Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, NK cell malignancies are eligible after initial therapy in CR1+ or PR1+. - Large Cell NHL > CR2/> PR2: Patients in CR2/PR2 with initial short remission ( 3 mg/L, may be considered for this protocol after initial therapy. - Myeloproliferative Syndromes - Organ Function Criteria Adequate organ function is defined as: - Liver: AST and ALT 1.2 mg/dl or a history of renal dysfunction must have estimated glomerular filtration rate (GFR) > 40 mL/min. - Albumin > 2.5 g/dL - Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 35%. - Pulmonary: DLCOcorr ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with or without exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note. - If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease - Females of child bearing potential and sexually active males must agree to use adequate birth control during study treatment - Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate) Exclusion Criteria: - Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. - Untreated active infection - Active CNS disease - Active HIV infection or known HIV positive serology - Congenital bone marrow failure syndrome - Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of TBI - CML in refractory blast crisis - Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky. - Multiple myeloma progressive on salvage chemotherapy
Gender All
Ages N/A - 75 Years
Accepts Healthy Volunteers No
Contacts †† Timothy Krepski, 612-273-2800, tkrepsk1@fairview.org
Location Countries † United States
Administrative Information
NCT ID † NCT02661035
Organization ID 2015LS152
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Masonic Cancer Center, University of Minnesota
Collaborators ††
Investigators † Principal Investigator: Erica Warlick, MD, Masonic Cancer Center, University of Minnesota
Information Provided By
Verification Date March 2017
First Received Date † January 19, 2016
Last Updated Date March 9, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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