Sirolimus & Mycophenolate Mofetil as GVHD prophylaxis in Myeloablative, Matched Related Donor HCT

Trial ID or NCT#

NCT01220297

Status

not recruiting iconNOT RECRUITING

Purpose

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)

Official Title

Sirolimus and Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation

Eligibility Criteria

Ages Eligible for Study: 2 to 60
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. EXCLUSION CRITERIA
  2. * 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).
Exclusion Criteria:
  1. * 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).
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Investigator(s)

Laura Johnston
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), Emerita

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Contact

BMT Referrals
6507230822

View on ClinicalTrials.gov