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

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01220297
First received: November 24, 2009
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL


Condition Intervention Phase
Hematologic Diseases
Drug: Sirolimus
Drug: Mycophenolate Mofetil
Drug: Carmustine
Drug: VP-16
Drug: cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sirolimus and Mycophenolate Mofetil as GVHD 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:
  • Incidence of grade II-IV acute GVHD at D+100 post-transplant [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade III-IV acute GVHD [ Time Frame: 100 days post transplant ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of MMF [ Time Frame: completion of study- at 2-3 years after institution ] [ Designated as safety issue: No ]
  • Veno-occlusive Disease Incidence of Infection CMV reactivation [ Time Frame: 100 days ] [ Designated as safety issue: No ]
  • Chronic GVHD Disease-free and Overall Survival [ Time Frame: approximately 1-2 years after completion of the study ] [ Designated as safety issue: No ]
  • Time to neutrophil and platelet engraftment Thrombotic microangiopathy Severity of Mucositis [ Time Frame: 100 days post-transplant per patient Thrombotic microangiopathy- as it occurs and/or 100 days post-transplant Mucositis- first 3 weeks post-transplant per patient; all patients - reviewed at completion of trial ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: September 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sirolimus
    12 mg loading dose, 4 mg QD, PO
    Other Names:
    • rapamycin
    • Rapamune
    Drug: Mycophenolate Mofetil
    15 mg/kg TID, IV or PO
    Other Name: MMF
    Drug: Carmustine
    15 mg/kg, IV
    Other Name: BCNU
    Drug: VP-16
    60 mg/kg, IV
    Other Names:
    • Vmw65
    • α-TIF
    • Trans Inducing Factor
    Drug: cyclophosphamide
    100-120 mg/kg, IV
    Other Names:
    • Endoxan
    • Cytoxan
    • Neosar
    • Procytox
    • Revimmune
    • cytophosphane
  Eligibility

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

Inclusion Criteria:

  • Disease Categories (participants will have one of the following)

    • AML, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease
    • AML, age 51-60 years of age, in first or subsequent remission or relapsed/refractory disease
    • AML with multilineage dysplasia
    • ALL, age 2 - 60 years beyond 2nd remission or relapsed/refractory disease
    • ALL, age 51 - 60 years in first or subsequent remission or relapsed/refractory disease
    • CML Beyond 2nd chronic phase or in blast crisis
    • MDS; Includes World Health Organization classifications of refractory anemia with excess blasts-1 (RAEB-1), RAEB-2 and therapy-related MDS
    • Myeloproliferative disorders; MDS with poor long-term survival including myeloid metaplasia and myelofibrosis
    • High risk NHL in first remission
    • Relapsed or refractory NHL
    • HL beyond first remission
  • Males and females of any ethnic background 2 - 60 years of age
  • Karnofsky Performance Status >= 70% or Lansky performance status > 70% for patients < 16 years of age.
  • Matched related donor identified

    • 6/6 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

Exclusion Criteria:

  • Prior myeloablative allogeneic or autologous HCT
  • HIV infection
  • Pregnant or lactating females
  • Evidence of uncontrolled active infection
  • Organ Dysfunction

    • Serum creatinine > 1.5 mg/dL or 24 hour creatinine clearance < 50 ml/min
    • Direct bilirubin, ALT or AST > 2 x ULN
    • In adults DLCO < 60% predicted and in children room air oxygen saturation < 92%
    • In adults, left ventricular ejection fraction < 45% and in children, shortening fraction < 26%
  • Fasting Cholesterol > 300 mg/dL or Triglycerides > 300 mg/dL while on lipid-lowering agents.
  • Patients receiving investigational drugs unless cleared by the PI.
  • 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 <= 5 years will not be allowed with PI 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: NCT01220297

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: Stanford University
ClinicalTrials.gov Identifier: NCT01220297     History of Changes
Other Study ID Numbers: BMT209, SU-09092009-3841
Study First Received: November 24, 2009
Last Updated: October 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hematologic Diseases
Cyclophosphamide
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Alkylating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014