Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer
NCT ID: NCT00053196
Last Updated: 2016-07-01
Study Results
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Basic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2002-12-31
2010-08-31
Brief Summary
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PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.
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Detailed Description
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* Determine the feasibility of non-myeloablative allogeneic hematopoietic stem cell transplantation by demonstrating that the risk of treatment-related mortality during the first 6 months is an acceptable rate of less than 40% in patients with relapsed hematologic malignancies after prior high-dose chemotherapy and autologous stem cell transplantation.
* Determine the response rates (disease-specific partial and complete response) in patients treated with this regimen.
* Determine the 6-month and 12-month probabilities of response in patients treated with this regimen.
* Determine the distribution of time-to-progression in patients responding to this regimen.
* Determine the percent donor chimerism in patients treated with this regimen.
* Determine the risk of acute and chronic graft-vs-host disease in patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine the disease-free and overall survival of patients treated with this regimen.
OUTLINE: This is an open-label study.
* Preparative Regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3 and busulfan IV over 2 hours every 6 hours (for a total of 8 doses) on days -4 and -3.
* Graft vs Host Disease (GVHD) Prophylaxis: Patients who have an HLA-identical donor receive oral (or IV if unable to tolerate oral administration) tacrolimus twice daily on days -1 to 90 followed by a taper\^\* until day 150 and methotrexate IV on days 1, 3, and 6. Patients with a matched related or matched unrelated donor receive oral (or IV if unable to tolerate oral administration) tacrolimus twice daily on days -1 to 180 followed by a taper\^\* as tolerated; methotrexate IV on days 1, 3, 6, and 11; oral mycophenolate mofetil twice daily on days -2 to 60 followed by a taper; and rabbit anti-thymocyte globulin IV over 4-6 hours on days -4 to -1 (for a total of 4 doses).
NOTE: \*Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is less than 50% at day 60 or patient has progressive disease
* Allogeneic Stem Cell Transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
* Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks.
Patients are followed within 2-3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non myeloblative allogeneic transplant
Non myeloblative allogeneic hematopoietic cell transplantation after prior autologous transplantation
anti-thymocyte globulin
2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)
G-CSF
5 ug/kg/day subQ injection Day 7 until ANC\> 1000/uL for 3 consec days
busulfan
0.8mg/kg IV infusion over 2 hrs q 6 hrs x 8 doses Days -4 thru -3
fludarabine phosphate
30 mg/sq m/day IVBP over 30 min Days -7 thru -3
methotrexate
5 mg/sq m/day IV infusion Days 1, 3, \& 6 for HLA-identical donor transplants and Days 1, 3, 6, \& 11 for MUD \& 9/10 related donor transplants
mycophenolate mofetil
15mg/kg PO bid Day -2 to Day 60, then taper as tolerated (for MUD and 9/10 related donor transplants only)
tacrolimus
target serum level is 5-10 ng/mL. Start with 0.03mg/kg PO bid Day -1 to Day 90, then taper thru Day 150 for HLA identical donor transplants and Day -1 to Day 180 then taper for MUD and 9/10 related donor transplants
allogeneic cell transplantation
2,000,000-8,000,000 CD34+ cells total via infusion Days 0 and 1
allopurinol
300 mg/day PO Days -8 thru -1
Interventions
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anti-thymocyte globulin
2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)
G-CSF
5 ug/kg/day subQ injection Day 7 until ANC\> 1000/uL for 3 consec days
busulfan
0.8mg/kg IV infusion over 2 hrs q 6 hrs x 8 doses Days -4 thru -3
fludarabine phosphate
30 mg/sq m/day IVBP over 30 min Days -7 thru -3
methotrexate
5 mg/sq m/day IV infusion Days 1, 3, \& 6 for HLA-identical donor transplants and Days 1, 3, 6, \& 11 for MUD \& 9/10 related donor transplants
mycophenolate mofetil
15mg/kg PO bid Day -2 to Day 60, then taper as tolerated (for MUD and 9/10 related donor transplants only)
tacrolimus
target serum level is 5-10 ng/mL. Start with 0.03mg/kg PO bid Day -1 to Day 90, then taper thru Day 150 for HLA identical donor transplants and Day -1 to Day 180 then taper for MUD and 9/10 related donor transplants
allogeneic cell transplantation
2,000,000-8,000,000 CD34+ cells total via infusion Days 0 and 1
allopurinol
300 mg/day PO Days -8 thru -1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed hematologic malignancy, including one of the following:
* Chronic lymphocytic leukemia (CLL)
* Absolute lymphocytosis greater than 5,000/mm\^3
* Lymphocytes must appear morphologically mature with less than 55% prolymphocytes
* Lymphocyte phenotype with expression of CD19 and CD5
* Prolymphocytic leukemia (PLL)
* Morphologically confirmed
* Absolute lymphocytosis greater than 5,000/mm\^3
* More than 55% prolymphocytes
* Non-Hodgkin's lymphoma or Hodgkin's lymphoma
* Any WHO histologic subtype allowed except mantle cell lymphoma
* Core biopsies allowed if they contain adequate tissue for primary diagnosis and immunophenotyping
* No bone marrow biopsy as the sole diagnostic means for follicular lymphoma
* Multiple myeloma
* Active disease requiring treatment
* Durie-Salmon stage I, II, or III
* Acute myeloid leukemia
* Documented control (i.e., less than 10% bone marrow blasts and no circulating blasts)
* Myelodysplastic syndromes
* Documented disease by WHO criteria
* Must have evidence of relapse/progression at least 6 months after prior high-dose chemotherapy with autologous hematopoietic stem cell support
* Absence of CD23 expression for CLL or PLL allowed provided there is no morphologic evidence of mantle cell lymphoma
* Availability of any of the following donor types:
* HLA-identical sibling (6/6)
* 9/10 matched related donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci
* Only a single mismatch at one class I or II allele allowed
* 10/10 matched unrelated donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci
* No syngeneic donors
PATIENT CHARACTERISTICS:
Age
* Under 70
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin no greater than 3 times upper limit of normal (ULN)
* AST no greater than 3 times ULN
Renal
* Creatinine clearance at least 40 mL/min
Cardiovascular
* LVEF at least 30% by MUGA
Pulmonary
* DLCO greater than 40%
* No symptomatic pulmonary disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No uncontrolled diabetes mellitus
* No active serious infection
* No known hypersensitivity to E. coli-derived products
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* More than 4 weeks since prior surgery
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Asad Bashey, MD, PhD
Role: STUDY_CHAIR
University of California, San Diego
Locations
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Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
St. Francis Hospital
Wilmington, Delaware, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Bashey A, Owzar K, Johnson JL, Edwards PS, Kelly M, Baxter-Lowe LA, Devine S, Farag S, Hurd D, Ball E, McCarthy P, Lister J, Shea TC, Linker C. Reduced-intensity conditioning allogeneic hematopoietic cell transplantation for patients with hematologic malignancies who relapse following autologous transplantation: a multi-institutional prospective study from the Cancer and Leukemia Group B (CALGB trial 100002). Biol Blood Marrow Transplant. 2011 Apr;17(4):558-65. doi: 10.1016/j.bbmt.2010.07.015. Epub 2010 Jul 30.
Bashey A, Owzar K, Johnson JL, et al.: Reduced-intensity allogeneic transplantation after failure of autologous transplantation: a prospective multi-center CALGB study. [Abstract] Blood 108 (11): A-3122, 2006.
Other Identifiers
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CALGB-100002
Identifier Type: -
Identifier Source: secondary_id
CDR0000269301
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-100002
Identifier Type: -
Identifier Source: org_study_id
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