• Overview
  • Eligibility
  • More info
  • Locations

A Randomized Trial to Evaluate Early High Dose Therapy and Autologous Bone Marrow Transplantation as Part of Planned Initial Therapy for Poor Risk Intermediate/High Grade NHL (NCT00003578)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether high dose chemotherapy plus bone marrow transplantation is more effective than high dose chemotherapy alone for intermediate- or high-grade non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy with or without bone marrow transplantation in treating patients who have intermediate- or high-grade non-Hodgkin's lymphoma.
  • Drug: CHOP regimen
    • Drug: carmustine
      • Drug: cyclophosphamide
        • Drug: cytarabine
          • Drug: doxorubicin hydrochloride
            • Drug: etoposide
              • Drug: melphalan
                • Drug: prednisone
                  • Drug: vincristine sulfate
                    • Procedure: autologous bone marrow transplantation
                      • Procedure: peripheral blood stem cell transplantation
                        Ages eligible for Study
                        16 Years to 65 Years
                        Genders eligible for Study
                        All
                        Accepts Healthy Volunteers
                        No
                        OBJECTIVES: I. Assess the value of early intensification with autologous bone marrow transplantation or stem cell support in patients with poor prognosis intermediate or high grade non-Hodgkin's lymphoma.

                        OUTLINE: This is a randomized, multicenter study. Patients are stratified by age (under 50 vs 50 and over), bone marrow involvement (yes vs no), and country. All patients receive cyclophosphamide, doxorubicin, and vincristine on day 1 and prednisone on days 1-5. Courses repeat every 21 days. Patients receive a minimum of 6 courses of treatment in the absence of disease progression and unacceptable toxicity. Arm I: Patients receive carmustine IV over 2 hours on day 1 in week 9 or 10. Etoposide and cytarabine IV are administered over 30 minutes on days 2-5. Melphalan IV is administered over 5 minutes on day 6. Patients receive cryopreserved bone marrow or peripheral blood stem cells on day 7. Arm II: Patients continue conventional therapy. Patients are followed at 8-9 weeks and 6 months.

                        PROJECTED ACCRUAL: This study will accrue 500 patients.

                        72 locations

                        Status:
                        unknown
                        Type:
                        Interventional
                        Phase:
                        Start:
                        31 December, 1992
                        Updated:
                        18 September, 2013
                        Participants:
                        500
                        A girl giving information about available additional trials.

                        FindMeCure helps you find, understand and join clinical trials from all over the world.

                        There are more clinical trials for your condition!