Clinical trial · Interventional
Combination Chemotherapy and Rituximab in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma
A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| pegfilgrastim | Biological | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete response rate
Secondary outcomes (2)
- measure
- Toxicity
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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 lymphomaReferences
Publications (1)
- DERIVEDMcMillan 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