Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
NCT ID: NCT00612716
Last Updated: 2020-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
6 participants
INTERVENTIONAL
1999-10-06
2019-12-15
Brief Summary
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PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.
Detailed Description
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* Determine if allogeneic stem cell transplantation using unrelated matched or related haploidentical donor bone marrow or unrelated matched cord blood results in timely, complete, and durable engraftment in patients with previously treated lymphoma, multiple myeloma, or chronic lymphocytic leukemia.
* Determine the incidence and grade of acute and chronic graft-versus-host disease in patients treated with this regimen.
* Determine if the augmented graft-versus-tumor effect accompanying unrelated or partially matched donor allogeneic transplant reduces the incidence of relapse in these patients.
OUTLINE:
* Preparative regimen: Patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and undergo total-body irradiation (TBI) twice daily on days -4 to -1. Patients who are unable to undergo TBI receive busulfan IV or orally 4 times daily on days -9 to -6 and cyclophosphamide IV over 2 hours on days -5 to -2.
* Stem cell transplantation: All patients undergo unrelated matched bone marrow or umbilical cord blood transplantation or partially matched related allogeneic bone marrow transplantation on day 0.
* Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis comprising methotrexate and cyclosporine. Patients may be enrolled in other protocols directed towards GVHD prophylaxis.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Allogeneic Transplantation
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
busulfan
For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.
cyclophosphamide
Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.
Stem cell infusion
Infused on Day 0
Total body irradiation
165 cGy morning and evening on days -4 through -1.
Interventions
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busulfan
For those not eligible for total body irradiation: busulfan 4 mg/kg/day orally (1 mg/kg orally every 6 hrs) on Days -9 through -6.
cyclophosphamide
Cyclophosphamide 60 mg/kg/day on days -7 and -6. For patients not eligible for total body irradiation: cytoxan 50 mg/kg intravenously (IV) on days -5 through -2.
Stem cell infusion
Infused on Day 0
Total body irradiation
165 cGy morning and evening on days -4 through -1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recipients will be \<55 years, will have satisfactory organ function (excluding bone marrow) and will have a Karnofsky activity assessment \>90% and will have:
* Creatinine \<2.0 mg/dl.
* Bilirubin, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2 x normal.
* Pulmonary function test and Carbon Monoxide Diffusing Capacity (DLCO) \> 50% of normal.
* Multi Gated Acquisition Scan (MUGA) \>45% injection fraction.
* Recipients with unrelated donor matched at the HLA A, B, DRBI loci, or if \< 35 years mismatched at a single HLA A or B, or DRBI locus.
* Umbilical cord blood (5) used as an unrelated stem cell source will provide \> 2.0 x 10\^7 cells/kg and will be matched at 4 - 6 of 6 HLA A, B, and DRBI loci. Cord blood grafts may include a single or pair of cord units depending on the cell dose.
* Partially matched related donors will be at least haploidentical (matched at \>3 of 6 HLA A, B, DRB1 loci).
* Recipients will fall under one of the following disease categories
* Chronic lymphocytic leukemia -- must have all three:
* Rai Stage III/IV
* Progression after previous Complete Response (CR) or Partial Response (PR) including purine antagonist (i.e. fludarabine).
* Recent chemotherapy responsiveness
* Advanced non-Hodgkin's lymphoma(NHL).
* Low-grade NHL (Working Formulation A, B, C) following progression after initial therapy if asymptomatic at diagnosis (\>CR2, \>PR2; response duration \< 1 year from last therapy) or if no CR was achieved (\>PR1). At least one prior therapy of intermediate intensity (e.g. CHOP).
* Mantle zone lymphoma after any progression following initial therapy (\>CR1, \> PR1). At least one prior therapy of intermediate intensity (e.g. CHOP).
* Intermediate grade lymphoma (\>PR2). Response duration \<1 year from prior therapy.
* High-grade Non-Hodgkin's Lymphoma (NHL) (IWF H, I, J) after initial therapy if \>stage III at diagnosis; after any progression even if localized (stage I, II) at diagnosis with prior response duration \< 1 year.
* Recent chemotherapy responsiveness after treatment with \> 3 intermediate intensity regimens.
* Advanced Hodgkin's disease beyond PR2 (\>CR3, \>PR3).
* Recent chemotherapy responsiveness
* Multiple Myeloma (\>CR2, \>PR2) or after initial therapy if no prior PR.
* Recent chemotherapy responsiveness
* Recipients will sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota.
Exclusion Criteria
55 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Daniel J. Weisdorf, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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9909M18181
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-MT1999-14
Identifier Type: OTHER
Identifier Source: secondary_id
1999LS060
Identifier Type: -
Identifier Source: org_study_id