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A Phase III Multicenter, Randomized Trial Comparing Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma


Phase 3
18 Years
72 Years
Open (Enrolling)
Both
Non-hodgkin Lymphoma, Hodgkin Lymphoma

Thank you

Trial Information

A Phase III Multicenter, Randomized Trial Comparing Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma


- Because no one knows which of the study options is best, participants will be
"randomized" into one of the two possible groups for GVHD prophylaxis: 1) a
sirolimus-containing regimen (tacrolimus, sirolimus and methotrexate) or 2) a
sirolimus-free regimen (tacrolimus and methotrexate or cyclosporine and mycophenolate
mofetil).

- Participants will receive a reduced intensity conditioning regimen. This is done to
prepare the body for transplantation. This will consist of a combination of drugs
(either fludarabine and busulfan or fludarabine, cyclophosphamide and low-dose total
body irradiation). The purpose of these drugs is to weaken the immune system and lower
the chance of the body rejecting the donated stem cells.

- Participants will also receive the GVHD prophylaxis regimen that they have been
randomized to. These drugs will lower the chance of rejecting the donor cells and
lower the chance of developing GVHD.


Inclusion Criteria:



- Patients will be eligible if their primary indication for transplantation is among
the following: Indolent B-cell non-Hodgkin lymphoma (NHL); Aggressive B-Cell NHL;
T-cell NHL; or Hodgkin Lymphoma.

- Patients must have one of the following combinations of disease status and disease
histology at the time of enrollment: 1) Patients may be transplanted as part of
first-line therapy if they have one of the following histologies: CLL with adverse
cytogenetics, MCL or, T-cell NHL. 2) Patients may be transplanted as part of
treatment for relapsed or refractory disease without a prior autologous
transplantation of they have one of the following histologies: Indolent NHL
(including CLL/SLL), MCL or T-cell NHL. 3) Patients may be transplanted as part of
treatment for disease that has relapsed or progressed after autologous
transplantation if they have any of the histologies listed above. Patients may also
be enrolled without a prior autologous transplantation if they have a
contraindication to autologous transplantation, in the opinion of the treating
clinician. 4) There is no minimal or maximal time interval from the patient's last
anti-lymphoma therapy and the time of transplantation.

- 18-72 years of age

- Matched related or matched unrelated donor

- Donor willing to donate peripheral blood stem cells and meeting institutional
criteria for stem cell donation. The donor must be medically eligible to donate stem
cells according to individual transplant center criteria.

Exclusion Criteria:

- Patients with Burkitt lymphoma or DLBCL with a c-myc rearrangement

- Karnofsky performance status of less than 70% at the time of registration

- Prior allogeneic stem cell transplantation (note that prior autologous stem cell
transplantation is allowed)

- Uncontrolled infection

- Serum creatinine 2.0mg/dl or greater

- Total bilirubin 2.0mg/dl or greater (unless related to hemolysis or Gilbert's
syndrome)

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times or greater
than the institutional upper limit of normal

- Left ventricular ejection fraction < 30%

- Cholesterol > 500mg/dl or triglycerides > 500 mg/dl despite appropriate treatment

- Seropositivity for HIV

- Pregnancy or breast-feeding (effective contraception must be used during therapy and
for at least 6 months after the end of immunosuppressive agents)

- Prior history of allergy to sirolimus, tacrolimus, cyclosporine, methotrexate or MMF

- Concomitant treatment with another investigational drug (unless cleared by study
chair)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the 2-year rate of overall survival of patients with lymphoma undergoing RIC SCT between those receiving Tacrolimus/Sirolimus/Methotrexate and those receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Philippe Armand, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

09-073

NCT ID:

NCT00928018

Start Date:

June 2009

Completion Date:

November 2014

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • allogeneic stem cell transplant
  • reduced intensity conditioning
  • graft versus host disease
  • GVHD
  • RIC transplantation
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617