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

NCT00028717 | Unknown Phase 3

• 5 other identifiers: CDR0000069122CKTO-2000-10HOVON-46NHLEU-20130HOVON-CKVO-2000-10
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 13

Brief Summary

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. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Event-free survival

Secondary Outcomes (4)

• Complete response

• Overall survival

• Disease-free interval

• Toxicity

Interventions

filgrastim BIOLOGICAL

rituximab BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

prednisone DRUG

vincristine sulfate DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Commissie Voor Klinisch Toegepast Onderzoek: lead

Study Sites (13)

Meander Medisch Centrum

Amersfoort, 3816 CP, Netherlands

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1081HV, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 EZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

HagaZiekenhuis - Locatie Leyenburg

The Hague, 2545 CH, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Isala Klinieken - locatie Sophia

Zwolle, 8000 GK, Netherlands

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Mantle-Cell

Interventions

Filgrastim; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood 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; 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

Study Officials

• Pieter Sonneveld, MD, PhD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Last Updated: September 17, 2013

Record last verified: 2007-11

Locations

NL (13)