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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052936
First received: January 24, 2003
Last updated: March 11, 2010
Last verified: June 2007
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without rituximab in treating aggressive non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying how well giving cyclophosphamide, doxorubicin, vincristine, and prednisone together with or without rituximab works in treating older patients who have aggressive non-Hodgkin's lymphoma. (This trial is no longer randomized as of 6/2005).


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Biological: rituximab
Drug: CHOP regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to treatment failure at 3 years within the study and then periodically after study completion [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response rate at 3 years within the study and then periodically after study completion [ Designated as safety issue: No ]
  • Progression rate [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
  • Tumor control [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 1580
Study Start Date: January 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   61 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052936

  Show 174 Study Locations
Sponsors and Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group
Investigators
Study Chair: Michael G.M. Pfreundschuh, MD Universitaetsklinikum des Saarlandes
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00052936     History of Changes
Other Study ID Numbers: CDR0000269015, DSHNHL-1999-1A, EU-20243
Study First Received: January 24, 2003
Last Updated: March 11, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Doxorubicin
Vincristine
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 19, 2014