Status:
COMPLETED
Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Lymphoma
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from d...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Central nervous system: Patients with a history of CNS involvement by lymphoma or with relapsed primary lymphoma will be eligible.
- 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
- Hodgkin's lymphoma (HL)
- patients with histologically proven HL will be eligible for transplantation after failing prior therapy.
Exclusion
- Patients eligible for any higher priority transplant protocols
- Women who are pregnant or breast feeding
- Patients with chemotherapy resistant disease
Key Trial Info
Start Date :
August 24 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2019
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00345865
Start Date
August 24 2005
End Date
June 28 2019
Last Update
July 14 2020
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455