NCT02728700

Sirolimus and Mycophenolate Mofetil in Preventing GVHD in Patients With Hematologic Malignancies Undergoing HSCT

Pilot Safety and Feasibility Trial of Mycophenolate and Sirolimus for Prevention of GVHD in Mismatched Unrelated and Related Donor Hematopoietic Stem Cell Transplantation for Hematologic Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 3 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I/II trial studies the side effects and how well sirolimus and mycophenolate mofetil work in preventing graft versus host disease (GvHD) in patients with hematologic malignancies undergoing hematopoietic stem cell transplant (HSCT). Biological therapies, such as sirolimus and mycophenolate mofetil, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving sirolimus and mycophenolate mofetil after hematopoietic stem cell transplant may be better in preventing graft-versus-host disease.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the safety and feasibility of administering sirolimus and mycophenolate mofetil (MMF) as prophylaxis of grade III-IV acute graft versus host disease (aGvHD) in patients undergoing mismatched unrelated and related donor hematopoietic stem cell transplant (HSCT). OUTLINE: Patients receive sirolimus orally (PO) starting on day -3, 3 times a week during hospitalization and then once a week for up to 6 months. Patients undergo HSCT on day 0. Patients also receive mycophenolate mofetil intravenously (IV) or PO three times a day (TID) on days 1-180. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at days 30, 60, 100, 180, 270, and 365, and then yearly thereafter.

Conditions

• Adult Hodgkin Lymphoma
• Adult Myelodysplastic Syndrome
• Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Childhood Hodgkin Lymphoma
• Childhood Myelodysplastic Syndrome
• Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Myelofibrosis
• Primary Myelofibrosis
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Adult Non-Hodgkin Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Recurrent Childhood Non-Hodgkin Lymphoma
• Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Refractory Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo HSCT
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Mycophenolate Mofetil	Given IV
DRUG	Sirolimus	Given PO

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-04-01
• Completion: 2018-07-01
• First posted: 2016-04-05
• Last updated: 2018-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study