Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)

Follicular Lymphoma Clinical Trial

Official title:

OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316613
• Other study ID #: ML20248
• Status: Completed
• Phase: N/A
• First received: November 28, 2014
• Last updated: January 28, 2016
• Start date: February 2007
• Est. completion date: April 2013

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:Commission nationale de l'informatique et des libertes CNIL
• Study type: Observational

Clinical Trial Summary

This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient (age >/= 18 years)

• Presenting with WHO grade 1-3, CD20-positive follicular non-Hodgkin's lymphoma, histologically confirmed at initial diagnosis

• In relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy

• Having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data

Exclusion Criteria:

• Patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion

• Follicular lymphoma presenting with a transformation to diffuse large cell non-Hodgkin's lymphoma

• First line treatment with radiotherapy alone

• Initial abstention from treatment (decision to not treat the progression at the time of inclusion in the OLYMPE study)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Rituximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase	At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.	Baseline	No
Primary	Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase	Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.	Induction Phase: 18.7 months	No
Primary	Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase	Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.	Induction Phase: 18.7 months	No
Primary	Percentage of Participants With MabThera as Maintenance Therapy	During the maintenance period participants received four weekly infusion of MabThera.	Maintenance/observation Phase: 67.8 months	No
Primary	Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase	After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.	Maintenance/observation Phase: 67.8 months	No
Primary	Duration of MabThera Maintenance Therapy When Associated With Observation	Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.	Maintenance/observation Phase: 67.8 months	No
Primary	Percentage of Participants With Prescription of Injection Prophylaxis	Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.	Maintenance/observation Phase: 67.8 months	No
Primary	Percentage of Participants With Injection Prophylaxis Treatment	Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.	Maintenance/observation Phase: 67.8 months	No
Primary	Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression	The therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.	Up to 6 years	No
Primary	Number of Participants With Therapeutic Management After the First Study Disease Progression	After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.	Up to 6 years	No
Secondary	Percentage of Participants With Last Induction Treatment Response	Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/µL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.	Induction Phase: 18.7 months	No
Secondary	Percentage of Participants With Number of Disease Progressions	Participants with at least one disease progression after the first study induction period were reported.	Up to 6 years	No
Secondary	Percentage of Participants With Disease Characteristics at First Study Disease Progression	Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).	Up to 6 years	No
Secondary	Progression Free Survival (PFS)	The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.	Up to 6 years	No
Secondary	Time to Next Treatment	Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.	Up to 6 years	No
Secondary	Overall Survival (OS)	The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.	Up to 6 years	No
Secondary	Number of Participants Who Used MabThera		Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)	No
Secondary	MabThera Regimen: Dose of MabThera	All participants who received MabThera treatment before the first disease progression were reported.	Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)	No
Secondary	MabThera Regimen: Infusion Duration		Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)	No
Secondary	MabThera Regimen: Number of Cycles of MabThera		Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)	No
Secondary	MabThera Regimen: Time Between Cycles		Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)	No
Secondary	Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase		Maintenance phase : 67.8 months	No
Secondary	Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score	The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much"). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items.	Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])	No
Secondary	Number and Type of Hospitalization Associated With MabThera Perfusion	Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.	Up to 6 years	No