Combination Chemotherapy and Rituximab in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma

NCT00974792 | Unknown Phase 2

• 4 other identifiers: CDR0000644893CRUK-UCL-R-CODOX-M/IVACEUDRACT-2005-003479-19EU-20956
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell 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 cell-killing substances to them. Giving more than one drug (combination chemotherapy) together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with diffuse large B-cell non-Hodgkin lymphoma.

Conditions

Lymphoma

Keywords

stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete response rate

Secondary Outcomes (2)

• Toxicity

• Progression-free survival

Interventions

pegfilgrastim BIOLOGICAL

rituximab BIOLOGICAL

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

etoposide phosphate DRUG

ifosfamide DRUG

leucovorin calcium DRUG

methotrexate DRUG

vincristine sulfate DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell non-Hodgkin lymphoma * International Prognostic Index (IPI) score high-intermediate (score = 3) OR high (score = 4 or 5), defined as: * Stage III or IV disease * Raised lactic dehydrogenase and poor performance status (WHO performance status 2-4) * All morphological variants included * B-cell nature of the proliferation must be verified by a positive anti-CD20 antibody (i.e., CD20-positive disease) * No T-cell lymphoma * No history of treated or non-treated indolent lymphoma * Patients newly diagnosed who have large B-cell lymphoma with some small cell infiltration in the bone marrow or lymph node may be allowed PATIENT CHARACTERISTICS: * See Disease Characteristics * Life expectancy \> 3 months * ANC \> 1,500/mm\^3\* * Platelet count \> 100,000/mm\^3\* * Serum creatinine \< 150 μmol/L\* * Serum bilirubin \< 35 μmol/L\* * AST and/or ALT \< 2.5 times upper limit of normal\* NOTE: \*Unless attributed to bone marrow infiltration by lymphoma. * Fertile patients must use effective contraception * Normal MUGA or echocardiogram without areas of abnormal contractility * LVEF ≥ 50% and only tested if patient meets 1 of the following criteria: * History of diabetes * Prior cardiac disease, hypertension, or abnormal resting ECG * No history of heart failure or uncontrolled angina pectoris * No cardiac contraindication to doxorubicin hydrochloride (e.g., abnormal contractility on echocardiography or MUGA) * No neurological contraindication to vincristine sulfate (e.g., pre-existing diabetic neuropathy) * No concurrent uncontrolled medical condition * No other serious active disease * No general status that, according to the investigator, does not allow the administration of 2 courses of CODOX-M/IVAC * No active malignant disease within the past 10 years except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix * No positive serology for HIV or hepatitis B or C * No medical or psychiatric conditions that compromise the patient's ability to give informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy, radiotherapy, or other investigational drug for diffuse large B-cell non-Hodgkin lymphoma

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

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (1)

Nottingham City Hospital

Nottingham, England, NG5 1PB, United Kingdom

RECRUITING

Related Publications (1)

• McMillan AK, Phillips EH, Kirkwood AA, Barrans S, Burton C, Rule S, Patmore R, Pettengell R, Ardeshna KM, Lawrie A, Montoto S, Paneesha S, Clifton-Hadley L, Linch DC. Favourable outcomes for high-risk diffuse large B-cell lymphoma (IPI 3-5) treated with front-line R-CODOX-M/R-IVAC chemotherapy: results of a phase 2 UK NCRI trial. Ann Oncol. 2020 Sep;31(9):1251-1259. doi: 10.1016/j.annonc.2020.05.016. Epub 2020 May 26.

  PMID: 32464282 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

pegfilgrastim; Rituximab; Cyclophosphamide; Cytarabine; Doxorubicin; etoposide phosphate; Ifosfamide; Leucovorin; Methotrexate; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; 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; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Oxazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• A. McMillan

  Nottingham City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: January 1, 2006
• Primary Completion: May 1, 2011
• Last Updated: August 26, 2013

Record last verified: 2009-09

Locations

GB (1)