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


Phase 2
2 Years
60 Years
Not Enrolling
Both
Leukemia, Lymphoma, Non-Hodgkin, Blood and Marrow Transplant (BMT)

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Time Frame:

D+100 post-transplant

Safety Issue:

Yes

Principal Investigator

Laura Johnston

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT184

NCT ID:

NCT00350181

Start Date:

August 2006

Completion Date:

April 2010

Related Keywords:

  • Leukemia
  • Lymphoma, Non-Hodgkin
  • Blood and Marrow Transplant (BMT)
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Stanford University School of MedicineStanford, California  94305-5317