Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Pati… (NCT00589563) | Clinical Trial Compass
CompletedPhase 2
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer
United States32 participantsStarted 2007-05
Plain-language summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops 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, antithymocyte globulin, and methotrexate before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well sirolimus, tacrolimus, and antithymocyte globulin work in preventing graft-versus-host disease in patients undergoing a donor stem cell transplant for hematological cancer .
Who can participate
Age range
2 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 hematological malignancy including any of the following:
* Non-Hodgkin lymphoma (NHL) in any complete remission (CR) or partial response (PR)
* Hodgkin lymphoma in any CR or PR
* Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in any CR
* Bone marrow blasts \< 20% within 4 weeks of transplant and peripheral blood absolute blast count \< 500/µL on the day of initiation of conditioning for patients with non-CR AML or ALL
* Myelodysplastic syndromes (MDS) treated or untreated
* Chronic myelogenous leukemia (CML) in chronic or accelerated phase
* Multiple myeloma in any CR or PR
* Chronic lymphocytic leukemia in CR or PR 2 or greater
* Myelofibrosis and other myeloproliferative disorders
* Bone marrow blasts \< 20% within 4 weeks of transplant and peripheral blood absolute blast count \< 500/µL on the day of initiation
* High-risk disease defined as AML or ALL \> CR1, accelerated phase CML, recurrent aggressive lymphoma, or active lymphoproliferative disease at transplant
* Low-risk disease defined as AML or ALL in CR1, chronic phase CML, or low-grade lymphoproliferative disorder with controlled disease at transplant
* Must be planning to receive 1 of the following conditioning regimens at City of Hope:
* Fludarabine phosphate and melphalan for patients with hematological malignancies and contraindications for conventional myeloablative regimens due to age, co-morbidity, or previous transpla…
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
Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
Timeframe: 100 Days Post Hematopoietic Stem Cell Transplant (HSCT)
2
Severity of Acute GVHD
Timeframe: 100 Days Post HSCT
3
Cumulative Incidence of Chronic GVHD
Timeframe: 2 year point estimate was provided.
4
Severity of Chronic GVHD
Timeframe: Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT