Back to resultsBusulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
Primary Purpose
Leukemia, Lymphoma, Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Busulfan
Fludarabine
Campath
Stem Cell Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Cancers of the blood
Eligibility Criteria
Inclusion Criteria:
Phase I portion:
- Relapsed or refractory acute myelogenous or lymphoid leukemia.
- Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- Recurrent or refractory malignant lymphoma or Hodgkin's disease
- Recurrent or refractory multiple myeloma.
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
- Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation
- Myelodysplastic syndromes with more than 5% blasts.
Phase II portion:
- AML with active disease or beyond CR2.
- MDS with more than 5% blasts.
Exclusion Criteria:
- Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Busulfan and fludarabine
Arm Description
Intravenous busulfan (Busulfan®) in combination with fludarabine
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
Secondary Outcome Measures
Overall Survival
Overall Survival measured as median survival in days
Disease Free Survival
Disease Free Survival measured by median survival time in days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00943319
Brief Title
Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
Official Title
A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is:
To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion.
To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
To evaluate potential pharmacogenomic determinants of toxicity of this regimen.
To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Myeloma
Keywords
Cancers of the blood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Busulfan and fludarabine
Arm Type
Experimental
Arm Description
Intravenous busulfan (Busulfan®) in combination with fludarabine
Intervention Type
Drug
Intervention Name(s)
Busulfan
Intervention Description
Daily intravenous dosing to target AVC
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.
Intervention Type
Drug
Intervention Name(s)
Campath
Intervention Description
All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Transplant
Intervention Description
Infusion of bone marrow and donors(related/ unrelated).
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival measured as median survival in days
Time Frame
5 years
Title
Disease Free Survival
Description
Disease Free Survival measured by median survival time in days
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Phase I portion:
Relapsed or refractory acute myelogenous or lymphoid leukemia.
Chronic myelogenous leukemia in accelerated phase or blast-crisis.
Recurrent or refractory malignant lymphoma or Hodgkin's disease
Recurrent or refractory multiple myeloma.
Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation
Myelodysplastic syndromes with more than 5% blasts.
Phase II portion:
AML with active disease or beyond CR2.
MDS with more than 5% blasts.
Exclusion Criteria:
Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Artz, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20919852
Citation
O'Donnell PH, Artz AS, Undevia SD, Pai RK, Del Cerro P, Horowitz S, Godley LA, Hart J, Innocenti F, Larson RA, Odenike OM, Stock W, Van Besien K. Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease. Leuk Lymphoma. 2010 Dec;51(12):2240-9. doi: 10.3109/10428194.2010.520773. Epub 2010 Oct 4.
Results Reference
derived
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Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
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