Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma
N/A
75 Years
Both
Lymphoma
Trial Information
Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma
OBJECTIVES:
Primary
- Determine the disease-free survival and overall survival of patients with non-Hodgkin's
or Hodgkin's lymphoma treated with autologous peripheral blood stem cell
transplantation (PBSCT).
- Verify the safety and efficacy of autologous PBSCT in patients with HIV disease and
relapsed lymphoma.
Secondary
- Evaluate immune reconstitution in HIV-positive patients undergoing autologous PBSCT and
compare to immune reconstitution in HIV-negative patients.
- Predict the adequacy of peripheral blood stem cell (PBSC) harvest prior to flow
analysis of a PBSC yield.
- Determine the time to engraftment for neutrophils and platelets.
OUTLINE:
- Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF) alone: Patients
not requiring further disease reduction receive G-CSF subcutaneously (SC) once daily on
days 1-8. Patients undergo PBSC collection by leukapheresis on days 5-8. Patients who
do not adequately mobilize with G-CSF alone proceed to chemo-mobilization.
- Chemo-mobilization: Patients requiring further disease reduction receive 1 of 2
chemo-mobilization regimens.
- Patients with CD20+ non-Hodgkin's lymphoma (NHL) or lymphocyte predominant
Hodgkin's lymphoma: Patients receive rituximab intravenously (IV) over 6-8 hours
on day 1, ifosfamide IV over 2 hours and etoposide IV over 30 minutes on days 2-4,
and carboplatin IV over 1 hour on day 2. Patients receive G-CSF SC once daily
beginning on day 7 and continuing until leukapheresis is completed. Patients
undergo PBSC collection by leukapheresis on days 12-15.
- All other patients: Patients receive ifosfamide IV over 2 hours and etoposide IV
over 30 minutes on days 1-3 and carboplatin IV over 1 hour on day 1. Patients
receive G-CSF SC once daily beginning on day 5 and continuing until leukapheresis
is completed. Patients undergo PBSC collection by leukapheresis on days 12-15.
- Autologous PBSC transplantation (PBSCT) (Patients with NHL undergoing irradiation):
Patients receive cyclophosphamide IV over 2 hours on days -7 and -6. Patients undergo
total body irradiation (TBI) twice daily on days -4 to -1. Patients undergo autologous
PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing
until blood counts recover.
- Autologous PBSCT (Patients with Hodgkin's lymphoma or NHL not undergoing irradiation):
Patients receive cyclophosphamide IV over 2 hours on days -6 to -3, carmustine IV over
1 hour on day -6, and etoposide IV over 4 hours twice daily on days -6 to -4. Patients
undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on
day 5 and continuing until blood counts recover.
- Post-transplant irradiation: Patients undergo post-transplant irradiation beginning on
day 28. Persisting nodal masses ≥ 2 cm are treated with additional localized external
beam irradiation.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Inclusion Criteria:
- Karnofsky performance status: >80% (>60% if poor performance status is related to
lymphoma)
- No evidence of serious organ dysfunction that is not attributable to tumor
- Infection: Patients with serious uncontrolled infections at the time of
transplant will be excluded
- Hepatitis B: Patients who are carriers of Hepatitis B will be included in this study.
These patients are not eligible to receive rituximab as a component of their
chemotherapy mobilization.
- HIV disease. Patients with HIV disease are eligible for this study provided that:
- Patients will be seen in the infectious disease (ID)/HIV clinic prior to
enrollment on study for the purpose of determining eligibility and for local
coordination of HIV care during the peri-transplant period.
- Must be on a maximally active anti-HIV regimen
- CD4+ ≥ 50/μL
- HIV RNA viral load ≤ 100,000 copies per mL on each of samples 4 weeks apart. The
most recent level must be within one month of enrollment.
- Non-Hodgkin's lymphoma (NHL). Patients with chemo-sensitive histologically confirmed
NHL.
- Precursor B-cell or Precursor T-cell NHL
- Lymphoblastic lymphoma
- All patients will be eligible in second or greater complete remission (CR) or
first or subsequent partial remission (PR)
- Mature B-cell Lymphomas: Small lymphocytic lymphoma (SLL) or Chronic
Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- Mantle Cell Lymphoma
- Burkitt's/Burkitt's like
- Mature T-cell lymphoma
- Patients may be transplanted under this protocol using a syngeneic (identical) twin
donor.
Exclusion Criteria:
- Patients eligible for any higher priority transplant protocols
- Women who are pregnant or breast feeding
- Patients with chemotherapy resistant disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients achieving complete response
Outcome Description:
response rate uses standard definition
Outcome Time Frame:
Day 100, 1 Year, 2 Years
Safety Issue:
No
Principal Investigator
Veronika Bachanova, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
2005LS048
NCT ID:
NCT00345865
Start Date:
November 2005
Completion Date:
August 2014
Related Keywords:
- Lymphoma
- Hodgkin lymphoma
- non-Hodgkin lymphoma
- HIV-associated lymphoma
- Hodgkin Disease
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
