Antithymocyte Globulin and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Chemotherapy With or Without Radiation Therapy Followed By Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
NCT ID: NCT00093587
Last Updated: 2013-11-06
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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UNKNOWN
NA
INTERVENTIONAL
2004-08-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well giving antithymocyte globulin together with cyclosporine works in preventing graft-versus-host disease in patients who are undergoing chemotherapy with or without radiation therapy followed by donor stem cell transplant for acute lymphoblastic leukemia or acute myeloid leukemia.
Detailed Description
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Primary
* Compare the incidence of acute graft-vs-host disease (GVHD) within the first 100 days after transplantation in patients with acute lymphoblastic leukemia or acute myeloid leukemia treated with a myeloablative conditioning regimen comprising cyclophosphamide (with or without radiotherapy) and low- vs high-dose anti-thymocyte globulin followed by allogeneic HLA-matched related stem cell transplantation and cyclosporine.
* Compare the incidence of serious adverse events within the first 100 days after transplantation in patients treated with these regimens.
Secondary
* Compare 100-day and 6-month survival in patients treated with these regimens.
* Compare the severity of acute GVHD in patients treated with these regimens.
* Compare the incidence of culture-proven infections at 100 days and 6 months after transplantation in patients treated with these regimens.
* Compare the incidence of mucositis, in terms of presence, severity, and duration, in patients treated with these regimens.
* Compare the number of days on opiate drugs within the first 30 days after transplantation in patients treated with these regimens.
* Compare the time to engraftment in patients treated with these regimens.
* Compare the incidence of hospitalization within the first 6 months after transplantation, in terms of length of initial stay, cumulative total days, and number of hospitalizations, in patients treated with these regimens.
* Compare the relapse rate and time to relapse in patients treated with these regimens.
* Compare the incidence and severity of chronic GVHD between 100 days and 6 months after transplantation in patients treated with these regimens.
OUTLINE: This is a pilot, randomized, open-label, multicenter study.
* Conditioning: All patients receive a standard myeloablative-conditioning regimen that contains cyclophosphamide IV over 2 hours per center regimen, typically on days -6 to -3. Patients also undergo total body irradiation OR receive busulfan.
* Graft-versus-host disease (GVHD) prophylaxis (as part of conditioning): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive low-dose anti-thymocyte globulin IV over 4-8 hours on days -3 to -1.
* Arm II: Patients receive high-dose anti-thymocyte globulin IV over 4-8 hours on days -5 to -1.
* Allogeneic hematopoietic stem cell transplantation: Patients in both arms undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0.
* Post-transplantation GVHD prophylaxis: Patients in both arms receive cyclosporine IV over 1-4 hours or orally twice daily beginning on day -1 and continuing until approximately day 60 followed by tapering doses until day 180 in the absence of GVHD.
Patients are followed at 7, 14, 21, 30, 100, and 180 days.
PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per treatment arm) will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
NONE
Interventions
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anti-thymocyte globulin
busulfan
cyclophosphamide
cyclosporine
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia
* In first complete remission or second complete remission
* Secondary AML allowed
* HLA-A, -B, and -DRB1 identical related donor available AND must be fully matched at Class II by high-resolution molecular HLA typing (at least 4 digits)
* Currently receiving a myeloablative conditioning regimen that includes cyclophosphamide
* All patients from a center should receive the same conditioning regimen throughout the study
* No fludarabine or other purine analogues (e.g. cladribine or pentostatin) as part of conditioning regimen
* No uncontrolled CNS disease
PATIENT CHARACTERISTICS:
Age
* 18 to 55
Performance status
* ECOG 0-3
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin \< 2 mg/dL
* ALT and/or AST ≤ 3 times normal
Renal
* Creatinine \< 2.0 mg/dL OR
* Creatinine clearance \> 50 mL/min
Cardiovascular
* Ejection fraction \> 40%
* No severe cardiac disease
Other
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known contraindication to administration of rabbit anti-thymocyte globulin
* No current drug or alcohol abuse
* No significant medical or psychosocial problem or unstable disease state (including, but not limited to, morbid obesity) that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior or concurrent bone marrow transplantation from a donor who has positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis
* No IV immunoglobulin prior to engraftment
* No concurrent ex vivo engineered or processed graft (CD34+ enrichment or T-cell depletion)
Chemotherapy
* See Disease Characteristics
* No prior or concurrent methotrexate for graft-vs-host disease prophylaxis
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 30 days since prior experimental agents
* No other concurrent investigational agents
* Enrollment in investigational studies (i.e., anti-microbial agents) allowed only for life threatening events or after exhausting other treatment modalities
18 Years
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Principal Investigators
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Gary J. Schiller, MD
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Countries
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Other Identifiers
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UCLA-0402009-01
Identifier Type: -
Identifier Source: secondary_id
GENZ-SMC-101-1026
Identifier Type: -
Identifier Source: secondary_id
CDR0000389241
Identifier Type: -
Identifier Source: org_study_id