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

Alternate Title

Combination Chemotherapy Plus Filgrastim With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	65 and over	Other	CKTO-2000-10 HOVON-46NHL, EU-20130, HOVON-CKVO-2000-10, NCT00028717

Objectives

1. Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), and filgrastim (G-CSF) with or without rituximab on event-free survival of elderly patients with intermediate or high-risk non-Hodgkin's lymphoma.
2. Compare the complete remission rate, overall survival, and disease-free survival of patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-Hodgkin's lymphoma (NHL)
  • Low- or high-intermediate or high-risk lymphoma of any of the following subtypes:
    • Mantle cell lymphoma
    • Follicular lymphoma (grade III)
    • Diffuse large B-cell lymphoma



• CD20-positive



• No suspected or documented CNS involvement by NHL

 [Note: 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.]

Prior/Concurrent Therapy:

Biologic therapy:

• No prior immunotherapy for NHL

Chemotherapy:

• No prior chemotherapy for NHL

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for NHL except local radiotherapy for potential organ dysfunction by localized lymphoma mass or infiltration
• Concurrent local radiotherapy for potential or actual organ dysfunction by localized lymphoma mass or infiltration allowed

Surgery:

• Not specified

Patient Characteristics:

Age:

• 65 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 1.75 mg/dL*
• Transaminases less than 2.5 times normal*

 [Note: * Unless due to NHL]

Renal:

• Creatinine less than 1.7 mg/dL (unless due to NHL)

Cardiovascular:

• No severe cardiac dysfunction
• No New York Heart Association class II-IV heart disease
• LVEF at least 45%

Pulmonary:

• No uncontrolled asthma requiring steroid treatment

Other:

• HIV negative
• No intolerance to exogenous protein administration
• No active, uncontrolled infection
• No uncontrolled allergy requiring steroid treatment
• No other malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer

Expected Enrollment

A total of 400 patients (200 per treatment arm) will be accrued for this study within 5 years.

Outcomes

Event-free survival

Complete response
Overall survival
Disease-free interval
Toxicity

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, WHO classification, and International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously on days 1-14. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive cyclophosphamide, doxorubicin, vincristine, prednisone, and G-CSF as in arm I. Patients also receive rituximab IV on day 3 of courses 1-2 and on day 1 of courses 3-6 for a total of 6 doses.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Commissie Voor Klinisch Toegepast Onderzoek

Pieter Sonneveld, MD, PhD, Protocol chair		Ph: 31-10-439-1911 Email: p.sonneveld@erasmusmc.nl

Registry Information
Official Title		A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma
Trial Start Date		2001-02-01
Registered in ClinicalTrials.gov		NCT00028717 1
Date Submitted to PDQ		2001-10-30
Information Last Verified		2007-11-30

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00028717