Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia
NCT ID: NCT00002831
Last Updated: 2018-10-26
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
PHASE1/PHASE2
24 participants
INTERVENTIONAL
1995-08-01
2002-12-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
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Detailed Description
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OUTLINE: In cohorts of 3, patients receive escalating doses of decitabine (DAC) IV over 4 hours on days -8 and -7. Busulfan is administered orally every 6 hours on consecutive days -6 through -4. Cyclophosphamide is given by vein (IV) over 1 hour on consecutive days -3 and -2. The maximum tolerated dose of DAC is defined as the dose at which 2 patients experience dose limiting toxicity. Donors receive filgrastim subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion. Leukapheresis is conducted daily. If insufficient number of cells are collected, blood marrow is harvested for supplementation. Stem cells are infused on day 0. For graft vs host disease prophylaxis (GVHD), patients receive tacrolimus IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus. Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment. All patients receive methylprednisolone given according to clinical grade of GVHD procedures. For CNS prophylaxis, methotrexate is given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment. Allogeneic patients are followed until the end of 1 year.
PROJECTED ACCRUAL: An estimated 30 allogeneic recipients will be recruited in 2 years for the expected study duration of 2-3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Deoxyazacytidine + Busulfan + Cyclophosphamide
Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation
Filgrastim
Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.
Busulfan
Administered orally every 6 hours on consecutive days -6 through -4.
Cyclophosphamide
Given intravenously (IV) over 1 hour on consecutive days -3 and -2.
Cyclosporine
Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.
Decitabine (DAC)
IV over 4 hours on days -8 and -7.
Methotrexate
Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.
Methylprednisolone
Given according to clinical grade of GVHD procedures.
Tacrolimus
IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.
Allogeneic Bone Marrow Transplantation
Infusion of stem cells on Day 0.
Peripheral Blood Stem Cell Transplantation
Stem cell infusion on Day 0.
Interventions
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Filgrastim
Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.
Busulfan
Administered orally every 6 hours on consecutive days -6 through -4.
Cyclophosphamide
Given intravenously (IV) over 1 hour on consecutive days -3 and -2.
Cyclosporine
Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.
Decitabine (DAC)
IV over 4 hours on days -8 and -7.
Methotrexate
Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.
Methylprednisolone
Given according to clinical grade of GVHD procedures.
Tacrolimus
IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.
Allogeneic Bone Marrow Transplantation
Infusion of stem cells on Day 0.
Peripheral Blood Stem Cell Transplantation
Stem cell infusion on Day 0.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 15 to 55 Performance status: Zubrod 0-2 Life expectancy: Life expectancy not severely limited by concurrent illness Hematopoietic: Not specified Hepatic: No evidence of chronic active hepatitis or cirrhosis Bilirubin no greater than 2 times upper limit of normal SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% No uncontrolled arrhythmias or symptomatic cardiac disease Pulmonary: FEV1, FVC, and DLCO at least 50% No symptomatic pulmonary disease Other: Related donor who is HLA-identical required No effusion or ascites greater than 1 L prior to drainage HIV negative Not pregnant No active CNS disease
PRIOR CONCURRENT THERAPY: Not specified
15 Years
55 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sergio Giralt, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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MDA-DM-94064
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G96-0999
Identifier Type: -
Identifier Source: secondary_id
CDR0000065033
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM94-064
Identifier Type: -
Identifier Source: org_study_id
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