Efficacy of Lenalidomide With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma
NCT ID: NCT01956695
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2013-09-18
2018-01-11
Brief Summary
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This study will assess the efficiency of the the combination of lenalidomide and rituximab in relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide alone in maintaining the response.
Detailed Description
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Stage 1: following the inclusion of the first 22 assessable patients, if 0 or 1 patient has an objective response (CR, Complete Response + uCR, unconfirmed Complete Response + PR, Partial Response) at the end of induction treatment, the study would be terminated early and the treatment will be considered ineffective. If 2 or more patients have an objective response at the end of induction treatment, then the treatment will be considered as effective in this indication. Otherwise, the second group of 23 patients will be recruited.
Stage 2: if at the end of recruitment, 8 or less patients have an objective response, the investigators will conclude to inefficacy, and if 9 or more patients have an objective response, then the treatment will be considered as effective and need further exploration.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenalidomide & Rituximab
Induction treatment : Lenalidomide 20 mg capsule on days 1 to 21 days of a 28 days cycle for the first cycle followed by 25 mg on daily on days 1 to 21 of a 28 days cycle for cycles 2 to 8 (in the absence of hematologic toxicity. Rituximab at day 1 of each induction course 375 mg/m² intravenous.
Maintenance : Lenalidomide 10 mg capsule on days 1 to 21 days of a 28 days cycle for 1 year or until progression or intolerance.
Lenalidomide
Rituximab
Interventions
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Lenalidomide
Rituximab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients can have received radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue as part of treatment of the PCNSL or IOL
3. Patients over 18 years old with a refractory or relapse IOL and who have received either intravenous high dose methotrexate (\> 1.5 g/m2) or intraocular methotrexate
4. Life expectancy \> 2 months
5. Able to swallow capsules (stomach tube not allowed)
6. Adequate bone marrow function with absolute leukocytes \> 2000/mm3, neutrophil count (ANC) \> 1000/mm3, haemoglobin \> 8 g/dl and platelets \> 100 000/mm3
7. Adequate liver function with Serum SGOT/AST or SGPT/ALT \< 3.0 X Upper Limit of Normal ULN ; bilirubin \< 1.5 X LNS (excepted in case of hemolytic anemia or Gilbert's syndrome)
8. Calculated creatinine clearance \> 40 ml/min. Patients with calculated creatinine clearance between 40 and 50ml/min lenalidomide dose will be adjusted as follows (10mg once daily)
9. Patient aged 18 years old or more and without measure of legal protection
10. Able to understand teratogenic risks of the treatment
11. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study for at least four weeks before starting study drug, while participating in the studyand for at least 4 weeks after discontinuation of Lenalidomide and 1 year after Rituximab.. Pregnancy tests (serum β-HCG dosage) will be negative at baseline and during the study. Men must agree not to procreate a child and use condoms if their partner can procreate, during all the treatment period, during dose interruptions and for at least 4 weeks after study drug discontinuation.
12. Signed inform consent
Exclusion Criteria
2. T-cell lymphoma
3. Diagnosis of any second malignancy within the last 5 years
4. Prior history of organ transplantation or other cause of severe immunodeficiency
5. History of heart disease and/or impaired cardiac function (ECG QTc\>450msec, congenital long QT syndrome, history of ventricular tachyarrhythmia, ventricular fibrillation, congestive heart failure NYHA III/IV, uncontrolled hypertension).
6. Known HIV or HTLV-1 infection, positive serology to HB surface antigen \[HBsAg\] or total HB core antibody \[anti-HB-c\]) and Hepatitis C (Hepatitis C virus \[HCV\] antibody) not older than 4 weeks
7. Inclusion in another experimental anti-cancer drug therapy\*
8. Impossibility to follow the calendar of exams because of geographic, social or psychological reasons
9. Patient under measure of legal protection
10. No social security \*For ethical reasons, the exclusion period within which the patient cannot be included in another trial will not be defined but discussed on a case to case basis.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
Institut Bergonié
OTHER
University Hospital, Clermont-Ferrand
OTHER
University Hospital, Lille
OTHER
Central Hospital, Nancy, France
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
Centre Henri Becquerel
OTHER
University Hospital, Tours
OTHER
Centre Leon Berard
OTHER
University Hospital, Grenoble
OTHER
Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Carole SOUSSAIN, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie - Hopital Rene Huguenin
Locations
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Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France
CHU Estaing
Clermont-Ferrand, Auvergne, France
CHU Bretonneau - Centre Henry Kaplan
Tours, Centre-Val de Loire, France
Institut Bergonié
Bordeaux, Gironde, France
Chu Michallon
Grenoble, Isère, France
Hôpital Central
Nancy, Lorraine, France
CHRU Lille - Hôpital Claude Huriez
Lille, Nord, France
Centre Henri Becquerel
Rouen, Seine Maritime, France
CHU Amiens -Hôpital Sud
Amiens, Somme, France
Chu La Timone
Marseille, , France
Hôpital de la Pitié Salpétrière
Paris, Île-de-France Region, France
Institut curie - Hôpital René Huguenin
Saint-Cloud, Île-de-France Region, France
Countries
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References
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Ghesquieres H, Chevrier M, Laadhari M, Chinot O, Choquet S, Molucon-Chabrot C, Beauchesne P, Gressin R, Morschhauser F, Schmitt A, Gyan E, Hoang-Xuan K, Nicolas-Virelizier E, Cassoux N, Touitou V, Le Garff-Tavernier M, Savignoni A, Turbiez I, Soumelis V, Houillier C, Soussain C. Lenalidomide in combination with intravenous rituximab (REVRI) in relapsed/refractory primary CNS lymphoma or primary intraocular lymphoma: a multicenter prospective 'proof of concept' phase II study of the French Oculo-Cerebral lymphoma (LOC) Network and the Lymphoma Study Association (LYSA)dagger. Ann Oncol. 2019 Apr 1;30(4):621-628. doi: 10.1093/annonc/mdz032.
Related Links
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Related Info
Other Identifiers
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2012-003786-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IC 2012-05
Identifier Type: -
Identifier Source: org_study_id