Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Years With Aggressive Non-Hodgkin's Lymphoma
61 Years
80 Years
Both
Lymphoma
Trial Information
Randomised Study Comparing 6 And 8 Cycles Of Chemotherapy With CHOP ( Cyclophosphamide, Doxorubicin, Vincristine And Prednisone) At 14-Day Intervals (CHOP-14), Both With Or Without The Monoclonal Anti-CD20 Antibody Rituximab In Patients Aged 61 To 80 Years With Aggressive Non-Hodgkin's Lymphoma
OBJECTIVES:
Primary
- Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, and prednisone
(CHOP) with vs without rituximab in elderly patients with aggressive non-Hodgkin's
lymphoma.
- Compare the efficacy of 6 vs 8 courses of CHOP chemotherapy in patients treated with
these regimens.
- Compare the rate of complete remission, rate of primary progression, tumor control,
disease-free survival, overall survival, and relapse after radiotherapy in patients
treated with these regimens.
- Compare the safety and side effects of these regimens in these patients.
Secondary
- Compare short-term and long-term side effects of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
- Compare the cost of these regimens in these patients.
- Determine relapse in patients treated with these regimens who received involved-field
radiotherapy.
OUTLINE: This is a randomized (randomized part of study completed as of 6/2005), open-label,
multicenter study. Patients are stratified according to participating center, value for
serum lactic dehydrogenase (no greater than upper limit of normal [ULN] vs greater than
ULN), bulky disease present (no vs yes), stage (I or II vs III or IV), general ECOG status
of patient (0 or 1 vs 2), and age (61 to 70 vs 71-80). Patients are randomized to 1 of 4
treatment arms. Patients with CD20-negative lymphoma are randomized to arms I or II only.
- Prephase treatment:Patients receive vincristine IV on day -6 and prednisone on day -6
to day 0 before initiating CHOP chemotherapy.
- Arm I (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy
comprising cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral
prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously once
daily on days 6-12 of each CHOP course. Treatment repeats every 2 weeks for 6 courses.
- Arm II (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy
and G-CSF as in arm I for a total of 8 courses.
- Arm III: Patients receive standard CHOP chemotherapy and G-CSF as in arm I. Patients
also receive rituximab IV before CHOP every 2 weeks for a total of 8 courses.
- Arm IV (closed to accrual as of 7/25/2005): Patients receive standard CHOP chemotherapy
and G-CSF as in arm II. Patients also receive rituximab IV before CHOP every 2 weeks
for a total of 8 courses.
In all arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
Beginning 3-6 weeks after completion of the last chemotherapy course, after complete
recovery of bone marrow, and after complete remision of mucositis, patients with sites of
initial bulky disease or extranodal involvement undergo radiotherapy 5 times a week for 4
weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: Approximately 1580 patients will be accrued for this study within 5
years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) by an excisional
biopsy of a lymph node or an extensive biopsy of an extranodal involvement (if there
is no lymph node involvement)
- CD20^+ B-cell lymphoma or CD20^- B-cell and T-cell lymphoma allowed
- B-cell NHL including the following:
- Stage III follicular lymphoma
- Stage III follicular lymphoma and diffuse B-cell lymphoma
- Lymphoblastic precursor B-cell lymphoma
- Diffuse large cell B-cell lymphoma
- Centroblastic
- Immunoblastic
- Plasmablastic
- Anaplastic large cell
- T-cell-rich B-cell lymphoma
- Primary effusion lymphoma
- Intravasal B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Mantle zone lymphoma, blastoid
- Burkitt's lymphoma
- Burkitt-like lymphoma
- Aggressive marginal zone lymphoma (monocytoid)
- T-cell NHL including the following:
- Lymphoblastic precursor T-cell lymphoma
- Peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS)
- Lennert's lymphoma
- T-zone lymphoma
- T-cell lymphoma of the angioimmunoblastic lymphadenopathy with dysproteinemia
(AILD) type
- Anaplastic large cell lymphoma
- ALK^+
- ALK^-
- Extranodal NK/T-cell lymphoma, nasal type
- Intestinal T/NK-cell lymphoma (with or without enteropathy)
- Hepatosplenic gamma-delta lymphoma
- Subcutaneous panniculitis-like PTCL
- Aggressive T/NK PTCL
- Anaplastic large-cell NHL, NOS
- Bone marrow involvement no more than 25%
- No lymphoma that is clearly restricted to the CNS or originating from the
gastrointestinal tract
PATIENT CHARACTERISTICS:
Age
- 61 to 80
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 2,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- No active hepatitis infection
Renal
- Creatinine no greater than 2 times ULN
Cardiovascular
- No Canadian Cardiovascular Society class III or IV angina pectoris
- No New York Heart Association class III or IV cardiac failure
- Ejection fraction at least 50%
- Fractional shortenings at least 25% by echocardiography or nuclear medicine
examination
Pulmonary
- FEV1 at least 50%
- Diffusion capacity at least 50%
Other
- No uncontrolled diabetes mellitus
- No known hypersensitivity to any study medications
- No other concurrent malignancy
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified
Other
- Must not have already initiated lymphoma therapy (except for the prephase treatment
specified for this study)
- No other concurrent lymphoma therapy
- No concurrent participation in another treatment study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to treatment failure at 3 years within the study and then periodically after study completion
Safety Issue:
No
Principal Investigator
Michael G.M. Pfreundschuh, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitaetsklinikum des Saarlandes
Authority:
United States: Federal Government
Study ID:
CDR0000269015
NCT ID:
NCT00052936
Start Date:
January 2001
Completion Date:
Related Keywords:
- Lymphoma
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage I adult lymphoblastic lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage IV adult diffuse large cell lymphoma
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- stage I mantle cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- stage I adult Burkitt lymphoma
- stage III adult Burkitt lymphoma
- stage IV adult Burkitt lymphoma
- contiguous stage II marginal zone lymphoma
- noncontiguous stage II marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage I marginal zone lymphoma
- stage III marginal zone lymphoma
- stage IV marginal zone lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
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