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CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

CLINICAL TRIALS

About Clinical Trials Find a Clinical Trial

Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

Trial ID or NCT#

NCT01106833

Status

NOT RECRUITING

Purpose

This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.

Official Title

A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus Plus Prednisone and Sirolimus/Calcineurin Inhibitor Plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease (BMT CTN Protocol #0801)

Eligibility Criteria

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria:

- Suitable candidates are patients with classic chronic GVHD or overlap syndrome (classic chronic plus acute GVHD)that is: a)Previously untreated (newly diagnosed) as defined by having received < 14 days of prednisone (or equivalent) before enrollment/randomization to study therapy; b)Previously treated but inadequately responding after ≤ 16 weeks of initial therapy with prednisone and/or calcineurin inhibitor (CNI) ± additional non-sirolimus agent (started at the time of chronic GVHD diagnosis). - Patient or guardian willing and able to provide informed consent. - Stated willingness to use contraception in women of childbearing potential. - Stated willingness of patient to comply with study procedures and reporting requirements.

Exclusion Criteria:

- Patients with late persistent acute GVHD or recurrent acute GVHD only. - Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day. - Receiving sirolimus for treatment of chronic GVHD (sirolimus for prophylaxis or treatment of acute GVHD is acceptable). - Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ≥ 0.25 mg/kg/day (or equivalent) ± additional agents. - Receiving therapy for chronic GVHD for more than 16 weeks. - Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies. - Inadequate renal function defined as measured creatinine clearance less than 50 mL/min/1.73 m^2 based on the Cockcroft-Gault formula (adults) or Schwartz formula (age less than or equal to 12 years). Adults: estimated creatinine clearance rate (eCCr) (mL/min/) = (140 - age) x mass (kg) x (0.85 if female)/72 x serum creatinine (mg/dL; Creatinine clearance (mL/min/1.73m^2) = eCCr x 1.73/Body Surface Area (BSA) (m^2); Children: eCCr (mL/min/1.73 m^2) = k x height (cm) / serum creatinine (mg/dL) k = 0.33 (pre-term), 0.45 (full term to 1 year old), 0.55 (age 1-12 years). - Inability to tolerate oral medications. - Absolute neutrophil count less than 1500 per microliter. - Requirement for platelet transfusions. - Pregnancy (positive serum β-HCG) or breastfeeding. - Receiving any treatment for persistent, progressive or recurrent malignancy. - Progressive or recurrent malignancy defined other than by quantitative molecular assays. - Known hypersensitivity to sirolimus.

View All Criteria

Investigator(s)

Robert Lowsky

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Sally Arai

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Judith Shizuru

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist, Hematologist-Oncologist

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Laura Johnston

Blood and marrow transplant specialist, Blood and marrow transplant specialist, Medical oncologist, Hematologist

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Robert Negrin

Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Wen-Kai Weng, MD, PhD

Blood and marrow transplant specialist, Blood and marrow transplant specialist, Lymphoma specialist, Medical oncologist, Multiple myeloma specialist

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

CONTACT

Physician Referrals
(650) 723-0822

View on ClinicalTrials.gov

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Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT

New to MyHealth?

ALREADY HAVE AN ACCESS CODE?

DON'T HAVE AN ACCESS CODE?

NEED MORE DETAILS?

MyHealth for Mobile

WELCOME BACK

Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

Investigator(s)

CONTACT