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Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma


Phase 2
N/A
75 Years
Open (Enrolling)
Both
Lymphoma

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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 MinnesotaMinneapolis, Minnesota  55455