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

• ClinicalTrials.gov Identifier: NCT00005867
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: June 26, 2013
• Sponsor: Lymphoma Trials Office
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: June 2, 2000
• First Posted Date: January 27, 2003
• Last Update Posted Date: June 26, 2013
• Study Start Date: January 1998
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: November 8, 2006): Overall survival in patients treated with mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, and prednisolone (PMitCEBO) versus cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP)
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: November 8, 2006): Failure-free survival, disease specific survival, relapse-free survival, death due to toxicity, response rate, and toxicity at 4 years
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
• Official Title: Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkin's Lymphoma

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

• 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).
• Compare the early and late toxicities of these regimens in these patients.

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.

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

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Primary Purpose: Treatment
• Condition: Lymphoma

Intervention

• Biological: bleomycin sulfate
• Drug: CHOP regimen
• Drug: cyclophosphamide
• Drug: doxorubicin hydrochloride
• Drug: etoposide
• Drug: mitoxantrone hydrochloride
• Drug: prednisolone
• Drug: vincristine sulfate

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 8, 2006): 310
• Original Enrollment: Not Provided
• Actual Study Completion Date: August 2007
• Primary Completion Date: Not Provided

Eligibility 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

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

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00005867
• Other Study ID Numbers: BNLI-CHOPVPMITCEBO-GOODRISK; CDR0000067900 ( Registry Identifier: PDQ (Physician Data Query) ); EU-99052
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Lymphoma Trials Office
• Collaborators: Not Provided

Investigators

• Study Chair: Ruth Pettengell, MD; St. George's Hospital

• PRS Account: National Cancer Institute (NCI)
• Verification Date: March 2007