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Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00117975
First received: July 8, 2005
Last updated: March 15, 2012
Last verified: March 2011

July 8, 2005
March 15, 2012
June 2005
June 2007   (final data collection date for primary outcome measure)
Overall response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
complete and partial response will be assessed
Not Provided
Complete list of historical versions of study NCT00117975 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)

RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one monoclonal antibody may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.

OBJECTIVES:

Primary

  • Determine the overall and complete response rate in patients with previously untreated CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma treated with rituximab and galiximab.
  • Determine the time to disease progression in patients treated with this regimen.

Secondary

  • Determine the toxicity profile of this regimen in these patients.
  • Correlate Fc receptor polymorphism profiling with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and galiximab IV over 1 hour on day 3, 8, 15, and 22.
  • Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 4 months for up to 10 years.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Biological: galiximab
    given IV
  • Biological: rituximab
    Given IV
Not Provided
Czuczman MS, Leonard JP, Johnson JL, et al.: FLIPI score is applicable and predictive of response to upfront immunotherapy in CALGB 50402: phase II trial of extended induction galiximab ([G] anti-CD80 monoclonal antibody) plus rituximab [R]. [Abstract] Blood 112 (11): A-1003, 2008.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
62
March 2017
June 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed* previously untreated follicular non-Hodgkin's lymphoma (NHL), meeting 1 of the following stage criteria:

    • Bulky stage II disease (i.e., at least 1 unidimensionally measurable mass ≥ 7 cm)
    • Stage III or IV disease NOTE: *Bone marrow biopsy as the sole means of diagnosis is not acceptable; fine needle aspiration is not acceptable
  • WHO grade 1, 2, or 3a disease (i.e., > 15 centroblasts per high power field with centrocytes present)
  • CD20-positive disease by flow cytometry or immunohistochemistry
  • Measurable disease by physical examination or imaging studies

    • Tumor mass > 1 cm
    • Patients with only nonmeasurable disease are not eligible

      • The following are considered nonmeasurable disease:

        • Bone lesions
        • Ascites
        • Pleural or pericardial effusion
        • Lymphangitis cutis or pulmonis
        • Bone marrow lesions
  • No known CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 50,000/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)* NOTE: *Unless due to lymphoma or Gilbert's disease

Renal

  • Creatinine ≤ 2 times ULN* NOTE: *Unless due to lymphoma

Immunologic

  • No known HIV positivity

    • HIV negative (for patients with a history of IV drug abuse or any behavior associated with an increased risk for HIV infection)
  • No known human anti-chimeric antibody positivity

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No other currently active* malignancy (including Waldenstrom's macroglobulinemia) except nonmelanoma skin cancer NOTE: *Patients who have completed prior anticancer therapy AND have < 30% risk for relapse are not considered to have a currently active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy (e.g., monoclonal antibody-based therapy) for NHL

Chemotherapy

  • No prior chemotherapy for NHL
  • No concurrent chemotherapy

Endocrine therapy

  • More than 2 weeks since prior corticosteroids except as maintenance therapy for a non-malignant disease
  • No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • No concurrent dexamethasone or other steroidal antiemetics except for the following circumstances:

    • Acute grade 3 or 4 monoclonal antibody-associated infusion reaction not responsive to transient discontinuation of antibody infusion or acetaminophen and diphenhydramine
    • Retreatment after an infusion reaction

Radiotherapy

  • No prior radiotherapy for NHL

Surgery

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00117975
CDR0000433340, U10CA031946, CALGB-50402
No
Cancer and Leukemia Group B
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Myron S. Czuczman, MD Roswell Park Cancer Institute
Cancer and Leukemia Group B
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP