Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies
NCT ID: NCT00593554
Last Updated: 2018-04-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2007-08-07
2017-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Total Body Irradiation
8 Gy on Day -9
Thiotepa
5 mg/kg/d on Day -8 to -7
Fludarabine
40 mg/m2/d on Day -6 to -3
Rabbit ATG
2.5 mg/kg/d on Day -5 to -2
2
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
Total Body Irradiation
8 Gy on Day -9
Thiotepa
5 mg/kg/d on Day -8 to -7
Fludarabine
40 mg/m2/d on Day -6 to -3
Rabbit ATG
2.5 mg/kg/d on Day -5 to -2
Palifermin
60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Interventions
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Total Body Irradiation
8 Gy on Day -9
Thiotepa
5 mg/kg/d on Day -8 to -7
Fludarabine
40 mg/m2/d on Day -6 to -3
Rabbit ATG
2.5 mg/kg/d on Day -5 to -2
Palifermin
60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CR 1 with poor risk features
* CR 2, or higher order CR
* Acute lymphoblastic leukemia (ALL) with one of the following criteria
* CR 1 with poor risk features
* CR 2, or higher order CR
* Myelodysplasia, RAEB I
* Donor has been identified
* Age ≤ 65 years.
* Performance Status 0-1.
Exclusion Criteria
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
* Non-pregnant and non-nursing
18 Years
65 Years
ALL
No
Sponsors
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Sherif S. Farag
OTHER
Responsible Party
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Sherif S. Farag
Lawrence H. Einhorn Professor of Oncology
Principal Investigators
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Sherif Farag, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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Indiana University Cancer Center
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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0704-19 IUCRO-0184
Identifier Type: -
Identifier Source: org_study_id
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