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

Stopped early · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02728700

Run by

Stanford University

People needed

1

Starts

2016-02-01

Expected to finish

2018-07-01

Last updated by the study team

2018-09-12

Who can join

Age: 3 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have one of the following disease categories:
• Acute myeloid leukemia (AML) beyond 2nd remission or relapsed/refractory disease
• Acute lymphoblastic leukemia (ALL) beyond 2nd remission or relapsed/refractory disease
• Chronic myeloid leukemia (CML) beyond 2nd chronic phase or in blast crises
• Myelodysplastic syndrome (MDS)
• Myeloproliferative disorders including myeloid metaplasia and myelofibrosis
• High risk non-Hodgkin's lymphoma (NHL) in first remission
• Relapsed or refractory NHL
• Hodgkin's lymphoma (HL) beyond first remission
• Performance status by Karnofsky of >= 70% or Lansky > 70% for patients < 16 years of age
• Human leukocyte antigen (HLA) mismatched related or unrelated donor identified 8/10 or 9/10
• Willingness to take oral medications during the transplantation period
• Willingness and ability to sign a written informed consent (assent if applicable)

You may not qualify if…

• Prior myeloablative allogeneic or autologous HSCT
• Human immunodeficiency virus (HIV) infection
• Pregnant or lactating females
• Evidence of uncontrolled active infection
• Down syndrome
• Serum creatinine (CR) < 1.5mg/dl or 24 hour CR clearance < 50 ml/min
• Direct bilirubin > 2 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
• Carbon monoxide diffusing capability test (DLCO) > 60% predicted and in children- room air oxygen saturation > 92%
• Left ventricular ejection fraction < 45% and in children-shortening fraction < 26%
• Fasting cholesterol > 300 mg/dl or triglycerides > 300 while on lipid lowering agents
• Patients who have received an investigational drug within 30 days of enrollment in study
• Patients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ; cancer treated with curative intent > 5 years will be allowed; cancer treatment with curative intent =< 5 years will not be allowed

Where it is running

• Stanford University, School of Medicine — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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