Diffuse large B cell non-hodgkin's lymphoma in the vulnerable/frail elderly. A multicentrix randomized phase II trial with emphasis on geritaric assesment and quality of life. - FRAIL 06

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001506-16-FR

Enrollment

120

Registered

2008-04-07

Start date

2008-07-07

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulnerable/Frail elderly patients older than 70 with diffuse large B-cell lymphoma stage II, III, or IV MedDRA version: 9.1 Level: LLT Classification code 10029547 Term: Non-Hodgkin's lymphoma

Interventions

Trade Name: MYOCET® Product Name: MYOCET® Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: doxorubicine Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age 70 years and older • Diffuse large B cell lymphoma NHL CD20 positive according to the WHO classification (Harris 1999) including all morphological and clinical variants and excluding Burkitt-like lymphoma (presence of small cells in the bone marrow biopsy is allowed) • Previously untreated • Ann Arbor stages II, III, IV • Performance status 0-3 • Presence of at least one measurable target lesion = 1.1 cm conforming to the IWC criteria • Patients in poor physiological status (all criteria will be checked during registration, patients who fulfill at least one of these following criteria will be considered in poor physiological status): a. Performance status = 3 (WHO scale) b. Cardiac evaluation: clinical evaluation and measurement of left ventricular ejection fraction that do not allow doxorubicin administration ( 30 mmol/l e. Any history of concomitant severe disease that would preclude patients being subjected to CHOP chemotherapy • Blood counts: neutrophils > 0.75 x 109/l and platelets > 50 x 109/l • Prior written patient informed consent must be given according to ICH/EU GCP, and national/local regulations (English and French versions are available in appendix 2 and 3) • For France only : Patients affiliés à un régime de sécurité sociale Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Left ventricular ejection fraction ?35% (whatever the method used) • Previous history of anthracycline administration with cumulated dose over either 240 mg/m² of doxorubicin or 400 mg/m² of 4-epidoxoubicin • Documented history of congestive heart failure, serious arrhythmia or myocardial infarction (within 6 months) • Documented history of allergy to eggs or egg products • Presence of cerebral and meningeal involvement • Presence of active infection • Serologic profile of active viral hepatitis B or C • MabThera contra-indication: Hypersensitivity to the active substance or to any of the excipients of the product or to murine proteins • Previous or concurrent second malignant solid tumor (except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix) which have been treated within the previous 5 years • Known HIV positivity • Patient unable to receive either R-COP or R-COPY schedules • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule • Participation at the same time in another study in which investigational drugs are used in the thirty days before the randomizatuion.

Design outcomes

Primary

Measure	Time frame
Main Objective: The principal objective of the trial is to assess the therapeutic efficacy (in terms of complete remission at 6 month, as defined by Cheson et al. 1999) and the safety of R-COP and R-COPY in vulnerable/frail elderly patients with diffuse large B cell non-Hodgkin’s lymphoma.;Secondary Objective: For each treatment, R-COP and R-COPY, we will evaluate: • the progression, event-free, and overall survival rates at six and 24 months • the overall response rate at six and 24 months • the duration of complete remission (in patients with an objective complete remission) • the acute side effects (graded according to the International "Common Toxicity Criteria") at six and 24 months • the geriatric condition through quality of life and geriatric assessment at various time points. ;Primary end point(s): The Bryant and Day design permits to jointly assess the efficacy and the toxicity of the treatment, where: • efficacy is defined as the achievement of a complete remission (as defined by Cheson et al., 1999) at six months; • toxicity is defined as the occurrence of severe toxicity, that is, febrile neutropenia, or toxic death, within one month following the end of the treatment. – Febrile neutropenia is defined in the International CTC toxicity scale as “fever of unknown origin without clinically or microbiologically documented infection: neutrophils < 1.0 x 109/l and fever =38.5° C”. – Toxic death is defined as any death which occur during treatment (from day 1 of the first cycle of chemotherapy up to day 30 of the last cycle) and is not related to lymphoma. Yet, because of the peculiarity of the patients treated (vulnerable/frail), because of previous experience of the occurrence of such death neither related to toxicity nor to lymphoma (EORTC 20992 phase II trial), interpretation of each death cause will be evaluated by an evaluation committee (hemato-oncologists, geriatricians, statistician) at the end of the trial. Efficacy and toxicity endpoints will be rev	—

Measure

Time frame

Main Objective: The principal objective of the trial is to assess the therapeutic efficacy (in terms of complete remission at 6 month, as defined by Cheson et al. 1999) and the safety of R-COP and R-COPY in vulnerable/frail elderly patients with diffuse large B cell non-Hodgkin’s lymphoma.;Secondary Objective: For each treatment, R-COP and R-COPY, we will evaluate: • the progression, event-free, and overall survival rates at six and 24 months • the overall response rate at six and 24 months • the duration of complete remission (in patients with an objective complete remission) • the acute side effects (graded according to the International "Common Toxicity Criteria") at six and 24 months • the geriatric condition through quality of life and geriatric assessment at various time points. ;Primary end point(s): The Bryant and Day design permits to jointly assess the efficacy and the toxicity of the treatment, where: • efficacy is defined as the achievement of a complete remission (as defined by Cheson et al., 1999) at six months; • toxicity is defined as the occurrence of severe toxicity, that is, febrile neutropenia, or toxic death, within one month following the end of the treatment. – Febrile neutropenia is defined in the International CTC toxicity scale as “fever of unknown origin without clinically or microbiologically documented infection: neutrophils < 1.0 x 109/l and fever =38.5° C”. – Toxic death is defined as any death which occur during treatment (from day 1 of the first cycle of chemotherapy up to day 30 of the last cycle) and is not related to lymphoma. Yet, because of the peculiarity of the patients treated (vulnerable/frail), because of previous experience of the occurrence of such death neither related to toxicity nor to lymphoma (EORTC 20992 phase II trial), interpretation of each death cause will be evaluated by an evaluation committee (hemato-oncologists, geriatricians, statistician) at the end of the trial. Efficacy and toxicity endpoints will be rev

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026