GM-CSF, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Follicular Non-Hodgkin Lymphoma

NCT00896519 | Unknown Phase 2

• 5 other identifiers: GOELAMS-FL2008-RCHOP-GMCDR0000637105FL2008-RCHOP-GMEUDRACT2007-007056-33RECF0907
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, 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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as GM-CSF, may cause the body to make more blood cells and help it recover from the side effects of rituximab and combination chemotherapy. PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab and combination chemotherapy works in treating patients with previously untreated advanced follicular non-Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall objective tumor response rate

Secondary Outcomes (8)

• Time to treatment progression

• Overall survival

• Duration of response

• Time to next treatment

• Safety profile

Interventions

rituximab BIOLOGICAL

sargramostim BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisone DRUG

vincristine sulfate DRUG

gene expression analysis GENETIC

gene rearrangement analysis GENETIC

polymerase chain reaction GENETIC

R-CHOP regimen OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed follicular non-Hodgkin lymphoma * Grade 1-3a disease * Advanced disease * Has undergone initial lymph node biopsy within the past 4 months * At least 1 measurable lesion * Bulky disease, as defined by the following GELF criteria: * Nodal or extranodal mass \> 7 cm in its greatest diameter * Involvement of ≥ 3 nodal sites (each with a diameter \> 3 cm) * B symptoms * Elevated serum LDH or β2-microglobulin * Splenic enlargement * Compression syndrome * Pleural and/or peritoneal effusion * No transformation to high-grade follicular lymphoma (secondary to low-grade follicular lymphoma) * No prior or concurrent CNS disease (i.e., CNS lymphoma or lymphomatous meningitis) NOTE: A new classification scheme for adult non-Hodgkin 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: * ECOG performance status 0-1 * Life expectancy ≥ 6 months * ANC ≥ 1,000/mm\^3\* * Platelet count ≥ 100,000/mm\^3\* * Hemoglobin ≥ 8.0 g/dL\* * Total bilirubin ≤ 2.0 mg/dL\* * AST ≤ 3 times upper limit of normal\* * Serum creatinine ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study treatment * No known HIV infection * No active hepatitis B or C infection * No serious underlying medical condition that would preclude study participation (e.g., ongoing infection, uncontrolled diabetes mellitus, gastric ulcer, active autoimmune disease, or heart failure) * No known sensitivity or allergy to murine products * No other prior or concurrent malignancies except nonmelanoma skin cancer or adequately treated in situ cervical cancer * No other co-existing medical or psychological condition that would preclude study participation or ability to give informed consent NOTE: \*Unless abnormalities are related to lymphoma PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior treatment for follicular lymphoma, including steroids or radiotherapy * More than 4 weeks since prior corticosteroids unless administered at a dose equivalent to \< 20 mg/day of prednisone * More than 28 days since prior major surgery (excluding lymph node biopsy) * More than 30 days since prior treatment in a clinical trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Rituximab; sargramostim; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine; Gene Expression Profiling; Gene Rearrangement; Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Genetic Techniques; Investigative Techniques; Genetic Phenomena; Nucleic Acid Amplification Techniques

Study Officials

• Jean-Francois Rossi, MD, PhD

  Hopital Lapeyronie-CHU Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 11, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2011
• Last Updated: August 2, 2013

Record last verified: 2009-07