Study Stopped
Lack of funding.
Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
A Pilot Phase II Study of Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
4 other identifiers
interventional
4
1 country
1
Brief Summary
This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and partially mismatched donors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2010
Typical duration 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
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 4, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
December 13, 2013
CompletedMarch 26, 2019
March 1, 2019
2.8 years
May 3, 2010
October 22, 2013
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence and Severity of Acute Graft-vs-host Disease (GVHD)
During the first six months post transplant
Time to Engraftment
During the first six months post transplant
Safety Assessment
During the first six months post transplant
Secondary Outcomes (5)
Incidence of Chronic GVHD
Within two years after transplant
Incidence of Infections Including Cytomegalovirus, Epstein-Barr Virus Reactivation, and Post-transplant Lymphoproliferative Disorder
At one year
Incidence of Thrombotic Microangiopathy
Within 100 days of HCT
Overall and Disease-free Survival
At 1 year
Immunocorrelative Studies Pre- and Periodically Post-transplantation
Using flow cytometry at 30, 60, 90, and 180 days post transplant.
Study Arms (1)
anti-thymocyte globulin, rituximab, sirolimus, tacrolimus,
EXPERIMENTALanti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC). Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
Interventions
Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter.
The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; if there is no reaction, increase the rate by 50 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Subsequent infusions: If patient did not tolerate initial infusion follow initial infusion guidelines. If patient tolerated initial infusion, start at 100 mg/hour; if there is no reaction, increase the rate by 100 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Note: If a reaction occurs, slow or stop the infusion. If the reaction abates, restart infusion at 50% of the previous rate. In patients who tolerated the Rituximab well in the past, a rapid infusion rate can be used over 90 minutes with 20% of the dose administered in the first 30 minutes and the remaining 80% is given over 60 minutes.
For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
laboratory biomarker analysis
allogeneic hematopoietic stem cell transplantation
management of therapy complications
peripheral blood stem cell transplantation
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)
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study terminated due to lack of funding. No analysis, patient data on this protocol due to the fact that only four patients was able to be accrued.
Results Point of Contact
- Title
- Zaid Al-Kadhimi, M.D.
- Organization
- Barbara Ann Karmanos Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Zaid Al-Kadhimi, M.D.
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
May 3, 2010
First Posted
May 4, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2013
Study Completion
June 1, 2013
Last Updated
March 26, 2019
Results First Posted
December 13, 2013
Record last verified: 2019-03