Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT02728700

Recruitment Status:

Terminated

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University, School of Medicine
Palo Alto California, 94304, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT02728700

Recruitment Status:

Terminated

Sponsor:


Stanford University

How clear is this clinincal trial information?

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