Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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.

Key facts

Study ID

NCT00345865

Run by

Masonic Cancer Center, University of Minnesota

People needed

473

Starts

2005-08-24

Expected to finish

2019-06-28

Last updated by the study team

2020-07-14

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients eligible for any higher priority transplant protocols
• Women who are pregnant or breast feeding
• Patients with chemotherapy resistant disease

Where it is running

• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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