Sirolimus, Tacrolimus, Antithymocyte Globulin, and Rituximab in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancers or Other Diseases Undergoing Donor Peripheral Blood Stem Cell Transplant

2014-08-27 03:13:59 | BioPortfolio


RATIONALE: Sirolimus, tacrolimus, antithymocyte globulin, and rituximab may be an effect treatment for graft-versus-host disease caused by a peripheral blood stem cell transplant.

PURPOSE: This phase II clinical trial is studying the side effects and how well giving sirolimus, tacrolimus, antithymocyte globulin, and rituximab together works in preventing graft-versus-host disease in patients with hematologic cancers or other diseases undergoing donor peripheral blood stem cell transplant.




- Determine the incidence and severity of acute graft-vs-host disease (GVHD) in patients with hematologic malignancies undergoing donor peripheral blood stem cell transplantation who are receiving sirolimus, tacrolimus, anti-thymocyte globulin, and rituximab as GVHD prophylaxis.

- Assess time to engraftment absolute neutrophil count (> 0.5 x 10^9/L for 3 consecutive days) and platelet count (> 20 x 10^9/L for 3 consecutive days) in these patients.

- Determine the safety, as defined by serious adverse events and adverse events related to this immunosuppressive regimen, in the first 6 months after treatment.


- Assess the incidence of chronic GVHD measured within 2 years after transplantation.

- Assess overall and disease-free survival at 2 years after transplantation.

- Examine the incidence of opportunistic infections including fungal infections, pneumocystis carinii pneumonia, and viral infections (cytomegalovirus, varicella zoster virus, herpes simplex virus, BK virus, Epstein-Barr virus, and post-transplant lymphoproliferative disorder).

- Assess the incidence of thrombotic microangiopathy within 100 days of transplantation.

- Perform immunocorrelative studies, including T-cell, B-cell, NK-cell, regulatory cell, and allo-reactive T-cell measurement studies via flow cytometry, at 30, 60, 90, and 180 days after transplantation.

OUTLINE: Patients receive rituximab IV on days -7 and 3, tacrolimus IV continuously (may switch to orally when the patient is able to eat) and oral sirolimus beginning on day -3, and anti-thymocyte globulin IV over 6 hours on days -3 to -1. Tacrolimus and sirolimus are tapered at the discretion of the treating physician.

All patients also receive a standard transplant-preparative regimen and undergo transplantation on day 0.

Blood samples are collected before the preparative regimen and at 30, 60, 90, and 180 days after transplantation for correlative immunologic studies.

After completion of study treatment, patients are followed up for 2 years.

Study Design

Masking: Open Label, Primary Purpose: Supportive Care


Chronic Myeloproliferative Disorders


anti-thymocyte globulin, rituximab, sirolimus, tacrolimus, laboratory biomarker analysis, allogeneic hematopoietic stem cell transplantation, management of therapy complications, peripheral blood stem cell transplantation


Not yet recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:59-0400

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Medical and Biotech [MESH] Definitions

A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.

A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-

Members of a family of highly conserved proteins which are all cis-trans peptidyl-prolyl isomerases (PEPTIDYLPROLYL ISOMERASE). They bind the immunosuppressant drugs CYCLOSPORINE; TACROLIMUS and SIROLIMUS. They possess rotamase activity, which is inhibited by the immunosuppressant drugs that bind to them.

A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.

Immunizing agent containing IMMUNOGLOBULIN G anti-Rho(D) used for preventing Rh immunization in Rh-negative individuals exposed to Rh-positive red blood cells.

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