Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT

Stopped early · Phase 2

Conditions studied: Hematologic Diseases, Acute-graft-versus-host Disease, Leukemia, Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma

In brief

A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)

Key facts

Study ID

NCT01220297

Run by

Stanford University

People needed

3

Starts

2006-08-01

Expected to finish

2011-08-01

Last updated by the study team

2017-06-05

Who can join

Age: 2 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute myelogenous leukemia (AML), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years
• AML, in first or subsequent remission or relapsed/refractory disease, age 51 to 60 years of age
• AML with multilineage dysplasia
• Acute lymphoblastic leukemia (ALL), beyond 2nd remission or relapsed/refractory disease, age 2 to 60 years
• ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease
• Chronic myeloid leukemia (CML), beyond 2nd chronic phase or in blast crisis
• Myelodysplastic syndrome (MDS), including World Health Organization (WHO)classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS
• MDS with poor long-term survival including myeloid metaplasia and myelofibrosis
• Myeloproliferative disorders
• High-risk non-Hodgkin lymphoma (NHL) in 1st emission
• Relapsed or refractory NHL
• Hodgkin lymphoma (HL) beyond first remission
• Males and females of any ethnic background, 2 to 60 years of age
• Karnofsky Performance Status (KPS) ≥ 70% or Lansky performance status > 70% for patients < 16 years of age.
• Related, matched-donor identified [6/6 human leukocyte antigen (HLA)-A, B and DRB1]
• Willingness to take oral medications during the transplantation period
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if…

• Prior myeloablative allogeneic or autologous hematopoietic stem cell transplant (HSCT)
• HIV infection
• Pregnant
• Lactating
• Evidence of uncontrolled active infection
• Serum creatinine > 1.5 mg/dL or 24-hour creatinine clearance < 50 mL/min
• Direct bilirubin, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN)
• Carbon monoxide diffusing capacity (DlCO) < 60% predicted (adults) OR and in-room air oxygen saturation < 92% (children)
• Left ventricular ejection fraction < 45% (adults) OR shortening fraction < 26%(children)
• Fasting cholesterol > 300 mg/dL or Triglycerides > 300 mg/dL while on lipid-lowering agents.
• Receiving investigational drugs unless cleared by the Principal Investigator (PI).
• Prior malignancies except basal cell carcinoma or treated carcinoma in-situ.
• Cancer treated with curative intent ≤ 5 years (EXCEPTION BY PI DISCRETION) (Cancer treated with curative intent > 5 years will be allowed).

Where it is running

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

Full record on ClinicalTrials.gov

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