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

November 24, 2009
October 7, 2011
September 2009
May 2011   (final data collection date for primary outcome measure)
Incidence of grade II-IV acute GVHD at D+100 post-transplant [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01220297 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Grade III-IV acute GVHD [ Time Frame: D100 post-transplan ] [ 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: VOD- ] [ 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: Time to neutrophil and platelet engraftment: D100 post-transplant per patient Thrombotic microangiopathy- as it occurs and/or D100 post-transplant Mucositis- first 3 weeks post-transplant per patient; all patients - reviewed at completion of trial ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematologic Diseases
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
May 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
2 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01220297
BMT209, SU-09092009-3841
Yes
Stanford University
Stanford University
Not Provided
Principal Investigator: Laura Johnston Stanford University
Stanford University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP