Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 to 59	Other	BNLI-CHOPVPMITCEBO-GOODRISK EU-99052, NCT00005867

Objectives

1. Compare the overall survival, failure free survival, disease specific survival, relapse free survival, and response rate in patients with aggressive non-Hodgkin's lymphoma treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).
2. Compare the early and late toxicities of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven previously untreated bulky stage IA or stage IB-IV aggressive non-Hodgkin's lymphoma of 1 of the following types:
  • Working formulation:
    • Follicular large cell
    • Diffuse mixed cell
    • Diffuse large cell
    • Diffuse immunoblastic

    OR

  • REAL classification:
    • Diffuse large B-cell
    • Peripheral T-cell



• Measurable or evaluable disease



• Good prognosis defined as no more than one of the following:
  • Stage III/IV disease
  • LDH greater than upper limit of normal
  • ECOG/WHO 2-4



• No lymphoblastic or Burkitt's lymphoma



• No CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to more than 35% of hematopoietic sites
• Concurrent consolidation radiotherapy allowed

Surgery:

• Not specified

Patient Characteristics:

Age:

• 18 to 59

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 10 g/dL
• Neutrophil count at least 2,000/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin, AST, and ALT no greater than 1.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.7 mg/dL

Cardiovascular:

• Ejection fraction at least 50% unless dysfunction attributable to lymphoma

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other concurrent serious uncontrolled medical conditions
• No other prior malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia

Expected Enrollment

A total of 310 patients (155 per arm) will be accrued for this study over 5 years.

Outcomes

Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)

Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years

Outline

This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1 and vincristine and bleomycin IV on day 8. Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment.



• Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, then every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Lymphoma Trials Office

Ruth Pettengell, MD, Protocol chair		Ph: 44-208-672-1255

Registry Information
Official Title		Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients with Histologically Aggresive Non Hodgkin's Lymphoma
Trial Start Date		1998-01-12
Registered in ClinicalTrials.gov		NCT00005867
Date Submitted to PDQ		2000-04-25
Information Last Verified		2007-03-26

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