Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
NCT ID: NCT00044954
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-11-30
2006-11-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.
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Detailed Description
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* Determine the response rate and duration of response in patients with low-risk hematologic malignancies treated with low-dose total-body irradiation (TBI) and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a slow immunosuppression taper and donor leukocyte infusions (DLI).
* Determine the response rate and duration of response in patients with high-risk hematologic malignancies treated with low-dose TBI and fludarabine followed by HLA-matched allogeneic stem cell transplantation followed by a faster immunosuppression taper and DLI.
* Determine the incidence and extent of graft-versus-host disease, regimen-related toxicity, and engraftment in patients treated with these regimens.
* Assess the quality of life of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28.
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months.
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months.
Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months.
Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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therapeutic allogeneic lymphocytes
cyclosporine
fludarabine phosphate
mycophenolate mofetil
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Grade III follicular large cell (relapsed after one course of prior chemotherapy)
* Diffuse large cell (relapsed after one course of prior chemotherapy)
* Mantle cell
* Chronic lymphocytic leukemia (CLL)
* Relapsed after at least 1 course of prior therapy
* Must have 6 out of 6 HLA A-, B-, and DR- identical sibling donor
PATIENT CHARACTERISTICS:
Age
* 18 to 75 for patients with MM
* 50 to 75 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL
* 18 to 49 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL who are considered eligible for an allogeneic bone marrow transplantation (BMT) but do not meet institutional criteria for a standard allogeneic BMT
Performance status
* Zubrod 0-2
Life expectancy
* At least 6 months
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 3 mg/dL
Renal
* Creatinine no greater than 2 mg/dL
Cardiovascular
* LVEF at least 40% by MUGA or echocardiogram
Pulmonary
* DLCO at least 50% of predicted
Other
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No recent history of drug or alcohol abuse
* No other prior malignancy except basal cell skin cancer
* No uncontrolled bacterial, viral, fungal, or parasitic infections
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior autologous transplantation allowed if disease progression occurred
* No prior or concurrent tandem autologous transplantation followed by non-myeloablative-allograft protocol
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
18 Years
75 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Principal Investigators
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Robert H. Collins, MD
Role: STUDY_CHAIR
Simmons Cancer Center
Locations
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Rocky Mountain Cancer Centers - Denver Midtown
Denver, Colorado, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Kansas City Cancer Centers - Central
Kansas City, Missouri, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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UTSMC-0799296
Identifier Type: -
Identifier Source: secondary_id
AMGEN-UTSMC-0799296
Identifier Type: -
Identifier Source: secondary_id
IBMTR-SC-00-03.1
Identifier Type: -
Identifier Source: secondary_id
ROCHE-UTSMC-0799296
Identifier Type: -
Identifier Source: secondary_id
SPRI-UTSMC-0799296
Identifier Type: -
Identifier Source: secondary_id
NCI-V02-1705
Identifier Type: -
Identifier Source: secondary_id
CDR0000069461
Identifier Type: -
Identifier Source: org_study_id
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