Diffuse large B-cell lymphoma Burkitt's lymphoma MedDRA version: 13.1 Level: PT Classification code 10006595 Term: Burkitt's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma
Conditions
Interventions
Trade Name: Mabthera
Product Name: Rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
C
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age 18-65 years (inclusive) b) Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL) and all morphological variants or Burkitt’s lymphoma, according to the current World Health Organisation classification1. The B cell nature of the proliferation must be verified by the positivity with an anti-CD20 antibody. All histology will be reviewed by a central Lymphoma Trials Office pathology panel. c) IPI score high-intermediate (score=3) or high (score=4, 5). IPI defined as stage III or IV, raised LDH, > 1 extranodal site and poor performance status – WHO performance status >/= 2. d) Patients with a positive serology for HIV 'There is increasing evidence of equivalent outcomes in HIV negative and positive individuals so it is no longer appropriate to exclude all patients who are HIV positive from entry into this study. However there are also grounds for believing that some HIV positive patients with poor immunological function and / or poor performance status may be put at risk with this very intensive programme of chemo-immunotherapy. Therefore for patients known to be HIV positive only patients with one or none of the following criteria will be eligible 1. CD4 cell count less than 100/_L, 2. Prior history of opportunistic infections, 3. Karnofsky performance score less than 60 or Eastern Cooperative Oncology Group score (ECOG) > 2 e) Disease stage II - IV f) No previous chemotherapy, radiotherapy or other investigational drug for this indication (although pre-treatment with steroids is acceptable) g) Adequate bone marrow function with platelets > 100x109/l; neutrophils > 1.5x109/l at the time of study entry unless attributed to bone marrow infiltration by lymphoma. h) Serum creatinine 3 months. m) Adequate contraceptive precautions for all patients of childbearing potential. n) Written, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Disease stage I b) T-cell lymphoma. c) Previous history of treated or non-treated indolent lymphoma. However, diffuse large B cell patients not previously diagnosed who have some small cell infiltration in bone marrow or lymph node may be included. d) Past history of heart failure or uncontrolled angina pectoris. e) Cardiac contra-indication to doxorubicin (abnormal contractility on echocardiography or nuclear medicine examination [MUGA]). f) Neurological contra-indication to vincristine (e.g. pre-existing diabetic neuropathy). g) Any other serious active disease. h) General status that does not allow the administration of 2 cycles of CODOX-M/IVAC according to the investigator. i) Patients with a positive serology for HIV not satisfying the inclusion criteria in section 5.3.1, Hepatitis B or Hepatitis C j) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary Outcome Measure: (1) Complete Response rate (CR and CRu) (2) Toxicity ;Primary end point(s): Progression Free Survival; Timepoint(s) of evaluation of this end point: - At months 4 and 12 post trial treatment - At follow up visits post trial treatment ; Main Objective: Does the combination of Rituximab and CODOX-M/IVAC improve the progression free survival in patients with newly diagnosed diffuse large B cell lymphoma or Burkitt's lymphoma of international prognostic index high or high-intermediate risk? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complete Response / Complete response uncertain Toxicity ; Timepoint(s) of evaluation of this end point: - Within 1 month of completing trial treatment - At months 4 and 12 post trial treatment | — |
Countries
United Kingdom
Contacts
Public ContactR-CODOX-M/IVAC Trial Coordinator
Cancer Research UK & UCL Cancer Trials Centre
Outcome results
None listed