Sirolimus and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis in Myeloablative Matched Related Donor Hematopoietic Cell Transplant

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00350181
First received: July 5, 2006
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

To evaluate the incidence of grade II-IV acute GVHD with sirolimus and mycophenolate mofetil GVHD prophylaxis.


Condition Intervention Phase
Leukemia
Lymphoma, Non-Hodgkin
Blood and Marrow Transplant (BMT)
Drug: Sirolimus
Drug: Mycophenolate Mofetil
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Sirolimus and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis in Myeloablative Matched Related Donor Hematopoietic Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To evaluate the incidence of grade II-IV acute GVHD with sirolimus and mycophenolate mofetil GVHD prophylaxis. [ Time Frame: D+100 post-transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 38
Study Start Date: August 2006
Study Completion Date: April 2010
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft versus host disease (GVHD) prevention in HLA matched related donor blood or marrow transplantation (BMT). This study will report the toxicities associated with this drug combination and also explore possible correlations between specific blood cell types and antibody production during this therapy.

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Diagnoses Included:

  1. Acute myelogenous leukemia (AML):

    - Age 2-60 years beyond 2nd remission or relapsed/refractory disease.

    • Age 51-60 years of age, in first or subsequent remission or relapsed/refractory disease
    • AML with multilineage dysplasia
  2. Acute lymphoblastic leukemia (ALL):

    - Age 2-60 years beyond 2nd remission or relapsed/refractory disease

    - Age 51-60 years in first or subsequent remission or relapsed/refractory disease

  3. Chronic myelogenous leukemia (CML), beyond 2nd chronic phase or in blast crisis
  4. Myelodysplastic syndrome (MDS) including patients with World Health Organization (WHO) refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS
  5. Myeloproliferative disorders with poor long- term survival including myeloid metaplasia and myelofibrosis
  6. Non-hodgkin lymphoma (NHL) - High risk NHL in first remission - Relapsed or refractory NHL
  7. Hodgkin lymphoma beyond first remission

Other Inclusion Criteria:

  1. Patients 2-60 years of age
  2. Matched related donor identified, 6/6 HLA-A, B and DRB1
  3. Karnofsky performance status >= 70% or Lansky performance status >= 70% or patients < 16 years old.
  4. Willingness and ability to take oral medications in pill form during the transplantation period.
  5. Informed consent

Exclusion Criteria:1. Prior myeloablative, allogeneic or autologous HCT. 2. HIV infection 3. Pregnant or lactating patients 4. Evidence of uncontrolled active infection 5. Renal function: serum creatinine >1.5 mg/dl or 24 hour creatinine clearance > 50 ml/min.

6. Hepatic function: direct bilirubin, ALT or AST > 2 x upper limit of normal 7. Pulmonary function: In adults, corrected diffusing capacity (DLCO) < 60% predicted and in children, room air oxygen saturation <92%.

8. Cardiac function: In adults, left ventricular ejection fraction < 45% and in children, shortening fraction < 26%.

9. Fasting Cholesterol > 300 mg/dl or Triglycerides >300 gm/dl while on lipid-lowering agents.

10.Patients receiving other investigational drugs unless cleared by the Principal Investigator.

11. Patients with prior malignancies except basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent > 5 years will be allowed. Cancer treated with curative intent d 5 years will not be allowed without Protocol Chair approval.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350181

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Laura Johnston Stanford University
  More Information

No publications provided

Responsible Party: Laura Johnston, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00350181     History of Changes
Other Study ID Numbers: BMT184, 97168, BMT184
Study First Received: July 5, 2006
Last Updated: October 7, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Graft vs Host Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Everolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 19, 2014