Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation
3 other identifiers
interventional
48
1 country
1
Brief Summary
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also 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 cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2008
Longer than P75 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
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
June 28, 2017
CompletedJune 28, 2017
May 1, 2017
5.9 years
June 4, 2008
December 9, 2015
May 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of Acute Graft-versus-host Disease (GVHD)
Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
Severity of Acute Graft-versus-host Disease (GVHD)
Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria
Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.
Within 6 months after PBSCT
Secondary Outcomes (5)
Incidence of Chronic GVHD.
Within 2 years after PBSCT
Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )
post transplant, up to 4 weeks
Overall Survival.
At 2 years after PBSCT
Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)
Within 6 months after PBSCT
Karnofsky Performance Status Performance Status
At 90 days after PBSCT
Study Arms (1)
Chemotherapy or chemotherapy + total body irradiation
EXPERIMENTALStandard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV;anti-thymocyte globulin IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV; anti-thymocyte globulin IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV; anti-thymocyte globulin IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI; anti-thymocyte globulin IV.
Interventions
Given IV
Given IV
Given IV
Given IV
Given IV
Given IV
Given once or twice daily
Given IV
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)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zaid Al-Kadhimi, M. D.
- Organization
- Barbara Ann Karmanos Institute
Study Officials
- STUDY CHAIR
Zaid Al-Kadhimi, MD
Barbara Ann Karmanos Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 5, 2008
Study Start
May 1, 2008
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
June 28, 2017
Results First Posted
June 28, 2017
Record last verified: 2017-05