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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


Phase 3
65 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


OBJECTIVES:

- 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.

- Compare the complete remission rate, overall survival, and disease-free survival of
patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

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.

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

Inclusion 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.

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Safety Issue:

No

Principal Investigator

Pieter Sonneveld, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000069122

NCT ID:

NCT00028717

Start Date:

February 2001

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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