Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Pa… (NCT01116232) | Clinical Trial Compass
TerminatedPhase 2
Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation
Stopped: Lack of funding.
United States4 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of a hematological malignancy, including:
* Non-Hodgkin lymphoma
* Hodgkin lymphoma
* Acute myeloid leukemia or acute lymphoblastic leukemia
* Myelodysplastic syndrome (treated or untreated)
* Chronic myelogenous leukemia
* Multiple myeloma
* Chronic lymphocytic leukemia
* Myelofibrosis and other myeloproliferative disorders
* No suitable related HLA-matched or unrelated HLA-matched (8/8 or 7/8 matched) donor
* Available suitable haploidentical or partial-matched unrelated donor (high-resolution molecular HLA typing is mandatory for HLA Class I and II)
* No more than 4/8 HLA allele or antigen mismatch for a haploidentical-related first-degree family member donor
* Only 6/8 or 5/8 allele or antigen match for an unrelated donor
* Scheduled to undergo peripheral blood stem cell transplantation
* Not receiving bone marrow or ex vivo engineered or processed graft (e.g., CD34+ enrichment, T-cell depletion)
* No documented uncontrolled CNS disease
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 70-100%
* ECOG PS 0-2
* Serum bilirubin \< 3 times upper limit of normal (ULN)
* ALT and AST \< 3 times ULN
* Creatinine clearance \> 60 mL/min
* Ejection fraction \> 50%
* Forced vital capacity, FEV\_1, or DLCO \> 50% predicted
* Negative pregnancy test
* Able to cooperate with oral medication intake
* Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and Severity of Acute Graft-vs-host Disease (GVHD)
Timeframe: During the first six months post transplant
2
Time to Engraftment
Timeframe: During the first six months post transplant
3
Safety Assessment
Timeframe: During the first six months post transplant