Autologous Peripheral Blood Stem Cell Transplant for Patients With Lymphoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 473
- Locations
- 1
- Primary Endpoint
- Number of Participants With 2 Years Progression Free Survival
Study Overview
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 dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving more chemotherapy, such as cyclophosphamide, carmustine, and etoposide, and total-body irradiation prepares the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy. More radiation therapy is given after transplant to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying how well autologous peripheral stem cell transplant works in treating patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma.
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 (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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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 Criteria
- •Patients eligible for any higher priority transplant protocols
- •Women who are pregnant or breast feeding
- •Patients with chemotherapy resistant disease
Arms & Interventions
NHL with irradiation
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: cyclophosphamide (Drug)
NHL with irradiation
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: peripheral blood stem cell transplantation (Procedure)
NHL with irradiation
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: irradiation therapy (Radiation)
NHL with irradiation
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: G-CSF (Biological)
HL without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: carmustine (Drug)
HL without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: cyclophosphamide (Drug)
HL without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: etoposide (Drug)
HL without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: peripheral blood stem cell transplantation (Procedure)
HL without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: G-CSF (Biological)
NHL - HIV infected with irradiation
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: cyclophosphamide (Drug)
NHL - HIV infected with irradiation
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: peripheral blood stem cell transplantation (Procedure)
NHL - HIV infected with irradiation
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: irradiation therapy (Radiation)
NHL - HIV infected with irradiation
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
Intervention: G-CSF (Biological)
NHL - HIV infected without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: carmustine (Drug)
NHL - HIV infected without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: cyclophosphamide (Drug)
NHL - HIV infected without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: etoposide (Drug)
NHL - HIV infected without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: peripheral blood stem cell transplantation (Procedure)
NHL - HIV infected without irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
Intervention: G-CSF (Biological)
NHL without radiation and cyclosporine
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Intervention: carmustine (Drug)
NHL without radiation and cyclosporine
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Intervention: etoposide (Drug)
NHL without radiation and cyclosporine
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Intervention: peripheral blood stem cell transplantation (Procedure)
NHL without radiation and cyclosporine
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Intervention: G-CSF (Biological)
NHL without radiation and cyclosporine
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Intervention: Cytarabine (Drug)
Outcomes
Primary Outcomes
Number of Participants With 2 Years Progression Free Survival
Time Frame: 2 years
Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.
Number of Participants With 1 Year Progression Free Survival
Time Frame: 1 year
Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.
Number of Participants With 1 Year Overall Survival
Time Frame: 1 year
Number of Participants With 2 Years Overall Survival
Time Frame: 2 years
Secondary Outcomes
- Number of Participants With Hematopoietic Recovery After Transplantation(Day 42)