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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


Phase 3
16 Years
65 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade adult
non-Hodgkin's lymphoma: Follicular large cell lymphoma Diffuse mixed cell lymphoma Diffuse
large cell lymphoma Diffuse immunoblastic lymphoma Poor prognostic features defined as the
presence of 2 or 3 of the following: Stage III/IV Lactase dehydrogenase greater than
normal ECOG performance status 2-4 A new classification scheme for adult non-Hodgkin's
lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma
will replace the former terminology of "low", "intermediate", or "high" grade lymphoma.
However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: See Disease Characteristics
Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease
Characteristics Renal: Not specified Other: No other medical condition prohibiting
intensive therapy

PRIOR CONCURRENT THERAPY: At least 5 years since prior systemic therapy for cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

David C. Linch

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals

Authority:

United States: Federal Government

Study ID:

CDR0000066645

NCT ID:

NCT00003578

Start Date:

January 1993

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

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