Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease
Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Ineligible or Inappropriate for Treatment With a More Intensive Therapeutic Regimen
2 other identifiers
interventional
71
1 country
1
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as busulfan and fludarabine, before a donor stem cell transplant helps stop the growth of cancer and abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Immunosuppressive therapy may improve bone marrow function and may be an effective treatment for hematologic cancer or other disease. PURPOSE: This clinical trial is studying the side effects and how well giving busulfan and fludarabine with or without antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer or other disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2007
CompletedFirst Posted
Study publicly available on registry
March 16, 2007
CompletedStudy Start
First participant enrolled
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2012
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedMay 30, 2017
May 1, 2017
4 days
March 14, 2007
April 17, 2017
May 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment-related Mortality
Treatment related mortality for first 6 months. Defined as the number of treatment related deaths excluding deaths due to disease relapse.
6 months
Secondary Outcomes (4)
Complete Response at 6 and 12 Months Post-transplant
6 and 12 months
Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant
Days 30, 60, and 90
5-year Disease-free Survival
Year 5
Graft-vs-host Disease at 6 Months Post-transplant
6 Months
Study Arms (4)
Methotrexate Only Arm
ACTIVE COMPARATORGVHD Prophylaxis with Methotrexate
2 Doses ATG + Methotrexate
ACTIVE COMPARATORGVHD prophylaxis with antithymocyte globulin (ATG) + Methotrexate
2 Doses ATG
ACTIVE COMPARATORGVHD prophylaxis with 2 doses ATG
3 Doses ATG
ACTIVE COMPARATORGVHD prophylaxis with 3 doses ATG
Interventions
0.5 mg/kg on day -3, 2.5 mg/kg on day -2 (groups 2, 3 and 4) and 3 mg/kg on day -1 (group 4 only)
GM-CSF 500 ug everyday (QD) subcutaneously will be given to recipients who remain with an Absolute neutrophil count (ANC) \< 1000/microliter (uL) past day 20
A minimum total cluster of differentiation 34 (CD34)+ cell dose of 3 x 10\^6 cells/kg and a maximum 8 x 10\^6 cells/kg will be infused on day 0
6.4 mg/kg by continuous IV infusion over 48 hours on Days -6 and -5
fludarabine 30 mg/m\^2/day x 5 days IV piggyback (IVPB) over 30 minutes on Days -7 through -3
Methotrexate 5 mg/m\^2 per day on days +1, +3 and +6
Suggested starting dose is 0.03 mg/kg po bid starting on Day -1
Minimum total CD34+ cells of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on Day 0
Minimum total CD34+ cells of 3 x 10\^6 cells/kg and a maximum of 8 x 10\^6 cells/kg will be infused on Day 0
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Per the protocol, non-serious adverse events were not captured as this was a high-dose transplant study and grades 1,2, and 3 adverse events were expected. No unexpected toxicities were seen beyond those reported in the Serious Adverse Event section.
Results Point of Contact
- Title
- Dr. Thomas Shea
- Organization
- UNC Lineberger Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas C. Shea, MD
UNC Lineberger Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2007
First Posted
March 16, 2007
Study Start
January 7, 2011
Primary Completion
January 11, 2011
Study Completion
May 23, 2012
Last Updated
May 30, 2017
Results First Posted
May 30, 2017
Record last verified: 2017-05