Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia
NCT ID: NCT00002833
Last Updated: 2012-07-30
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
53 participants
INTERVENTIONAL
1994-10-31
2002-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
Detailed Description
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OUTLINE: The trial will have 2 patient groups. Patients not in remission are assigned to group 1, while patients in remission are assigned to group 2. Then, groups are divided into 2 treatment arms. Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2 hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C, patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5 days. Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and -4. Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection. Cells are infused on day 0. For GVHD prophylaxis, all patients receive cyclosporine via continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered 10% weekly until discontinued. Methylprednisolone begins 5 days after infusion and is gradually tapered.
PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36 months.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group 1A
Group 1A - With or Without Remission + Failing Fludarabine therapy:
Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3 with Cladribine continuous infusion for 5 days, beginning 4 hours before Ara-C first dose. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered.
Filgrastim
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
Cladribine
Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
Cyclosporine
For GVHD prophylaxis, cyclosporine via continuous IV infusion. Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion. Then dose tapered 10% weekly until discontinued.
Cytarabine (Ara-C)
Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
Idarubicin
IV Days -6, -5 and -4.
Methylprednisolone
Begins 5 days after infusion and is gradually tapered.
Peripheral Blood Stem Cell Transplantation
Cell infusion Day 0.
Group 1B
Group 1B: With or Without Remission, No previous Fludara Therapy
Fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered.
Filgrastim
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
Cyclosporine
For GVHD prophylaxis, cyclosporine via continuous IV infusion. Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion. Then dose tapered 10% weekly until discontinued.
Cytarabine (Ara-C)
Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
Fludarabine Phosphate
IV over 30 minutes daily on days -6, -5, -4 and -3.
Idarubicin
IV Days -6, -5 and -4.
Methylprednisolone
Begins 5 days after infusion and is gradually tapered.
Peripheral Blood Stem Cell Transplantation
Cell infusion Day 0.
Interventions
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Filgrastim
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
Cladribine
Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
Cyclosporine
For GVHD prophylaxis, cyclosporine via continuous IV infusion. Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion. Then dose tapered 10% weekly until discontinued.
Cytarabine (Ara-C)
Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
Fludarabine Phosphate
IV over 30 minutes daily on days -6, -5, -4 and -3.
Idarubicin
IV Days -6, -5 and -4.
Methylprednisolone
Begins 5 days after infusion and is gradually tapered.
Peripheral Blood Stem Cell Transplantation
Cell infusion Day 0.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 55 to 65 65 to 70 (at the discretion of study chairperson on basis of performance status) 55 and under (if declined for conventional high dose chemotherapy due to concurrent medical conditions (i.e. ejection fraction less than 50, FEV1, FVC, or DLCO less than 50%, abnormal LFTs) Performance status: Zubrod less than 2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Serum creatinine less than 2 mg/dL Cardiovascular: Ejection fraction greater than 40% per MUGA scan Pulmonary: Not specified Other: No active uncontrolled infection HLA compatible donor capable of donating stem cells via apheresis
PRIOR CONCURRENT THERAPY: Not specified
55 Years
70 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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Related Links
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UT MD Anderson Cancer Center
Other Identifiers
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MDA-DM-94078
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-G96-1001
Identifier Type: -
Identifier Source: secondary_id
CDR0000065035
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM94-078
Identifier Type: -
Identifier Source: org_study_id