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Efficacy of Lenalidomide With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma

Information source: Institut Curie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma; Relapse; Lenalidomide; Rituximab

Intervention: Lenalidomide (Drug); Rituximab (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Institut Curie

Official(s) and/or principal investigator(s):
Carole SOUSSAIN, MD, Principal Investigator, Affiliation: Institut Curie - Hopital Rene Huguenin

Overall contact:
Patricia TRESCA, UGEC Leader, Phone: 33156245630, Email: patricia.tresca@curie.net

Summary

Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be observed in PCNSL. 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.

Clinical Details

Official title: Phase II Study Evaluating the Efficacy of Lenalidomide in Association With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma (PCNSL)

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assess the efficacy of lenalidomide in combination with rituximab in relapsed/refractory PCNSL as measured by the objective response rate (CR + uCR + PR) at the end of the 8 cycles of induction therapy.

Secondary outcome:

The safety of the association during induction and maintenance therapy in a population of PCNSL (NCI V4)

The duration of response

Progressive Free Survival at one year from the date of inclusion to the date of progression of the disease or death

Overall Survival from the date of inclusion to the date of death

Quality of life using QLQ-C30 EORTC (European Organization for Research and Treatment of Cancer) questionnaire

Detailed description: The investigators use a two-stage Fleming's design based on the following hypotheses under treatment: 10% (null hypothesis, minimal clinical benefit rate), 30% (alternative hypothesis, acceptable clinical benefit rate), 3% type I error rate, 5% type II error rate. Under these hypotheses, a total of 45 assessable patients will be necessary: 22 for the first stage + 23 for the second stage. 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients over 18 years old with a refractory or relapse PCNSL and who have previously

received at least high dose methotrexate (> 1. 5 g/m²) and high dose cytarabine (2 g/m²)

- Patients can have received radiotherapy or intensive chemotherapy with hematopoietic

stem cell rescue as part of treatment of the PCNSL or IOL

- Patients over 18 years old with a refractory or relapse IOL (Intra Ocular Lymphoma)

and who have received either intravenous high dose methotrexate (> 1. 5 g/m2) or intraocular methotrexate

- Life expectancy > 2 months

- Able to swallow capsules (stomach tube not allowed)

- Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count

(ANC) > 1000/mm3, haemoglobin > 8 g/dl and platelets > 100 000/mm3

- Adequate hepatic function with AST (aspartate aminotransferase) or ALT (alanine

aminotranferase) < 3 times the upper limit of normal (ULN), bilirubin < 1. 5 x ULN (except in cases of haemolytic anemia or Gilbert's syndrome)

- 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)

- Patient aged 18 years old or more and without measure of legal protection

- Able to understand teratogenic risks of the treatment

- 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 and for at least 4 weeks after discontinuation treatment with lenalidomide and one year after cessation of treatment with rituximab. Pregnancy test (βHCG amount) must be negative at the inclusion 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 including any interruption of catches and 4 weeks after the end of treatment.

- Signed inform consent

Exclusion Criteria:

- Any severe infection and/or active (eg tuberculosis, sepsis and opportunistic

infections), immune deficiency and hypersensitivity to any drug contained in the chemotherapy regimen or to any of their excipients (including lactose intolerance

- T-cell lymphoma

- Diagnosis of any second malignancy within the last 5 years

- Prior history of organ transplantation or other cause of severe immunodeficiency

- History of cardiac and /or impaired cardiac function disorders (ECG QTc (corrected QT

interval)>450 msec, congenital long QT syndrome, history of ventricular tachyarrhythmias, ventricular fibrillation or simply "torsade", congestive heart failure NYHA (New York Heart Association)III/IV, uncontrolled hypertension)

- Known HIV infection or active hepatitis B or HCV (hepatitis C virus) infection of

less than 4 weeks

- Inclusion in another experimental anti-cancer drug therapy

- Impossibility to follow the calendar of exams because of geographic, social or

psychological reasons

- Patient under guardianship

- No social security

Locations and Contacts

Patricia TRESCA, UGEC Leader, Phone: 33156245630, Email: patricia.tresca@curie.net

CHU Estaing, Clermont-Ferrand, Auvergne 63003, France; Recruiting
Cécile Molucon-Chabrot, MD, Email: cchabrot@chu-clermontferrand.fr
Cécile Molucon-Chabrot, MD, Principal Investigator

CHU Bretonneau - Centre Henry Kaplan, Tours, Centre 37044, France; Recruiting
emmanuel gyan, MD, Email: emmanuel.gyan@univ-tours.fr
Emmanuel Gyan, MD, Principal Investigator

Institut Bergonié, Bordeaux, Gironde 33076, France; Recruiting
Anna Schmitt, Phd, Email: a.schmitt@bordeaux.unicancer.fr
Anna Schmitt, MD, Principal Investigator

Hôpital de la Pitié Salpétrière, Paris, Ile de France 75013, France; Recruiting
Sylvain Choquet, MD, Email: sylvain.choquet@psl.aphp.fr
Sylvain Choquet, MD, Principal Investigator

Institut curie - Hôpital René Huguenin, Saint-Cloud, Ile de France 92210, France; Recruiting
Carole Soussain, MD, Phone: +33147111515, Email: carole.soussain@curie.net
Carole Soussain, MD, Principal Investigator

Chu Michallon, Grenoble, Isère 38043, France; Recruiting
Rémy Gressin, MD, Email: RGressin@chu-grenoble.fr
Rémy Gressin, MD, Principal Investigator

Hôpital Central, Nancy, Lorraine 54036, France; Recruiting
Patrick Beauchesne, MD, Phone: +331383851688, Email: p.beauchesne@chu-nancy.fr
Pactrick Beauchesne, MD, Principal Investigator

CHRU Lille - Hôpital Claude Huriez, Lille, Nord 59037, France; Recruiting
Franck Morschhauser, MD, Email: franck.morschhauser@chru-lille.fr
Franck Morschhauser, MD, Principal Investigator

Centre Léon Bérard, Lyon, Rhône-Alpes 39373, France; Recruiting
Hervé Ghesquières, MD, Email: herve.ghesquieres@lyon.unicancer.fr
Hervé Ghesquieres, MD, Principal Investigator

Centre Henri Becquerel, Rouen, Seine Maritime 76038, France; Active, not recruiting

CHU Amiens -Hôpital Sud, Amiens, Somme 80054, France; Recruiting
Ghandi Laurent Damaj, MD, Email: damaj.gandhi@chu-amiens.fr
Gandhi Damaj, MD, Principal Investigator

Additional Information

Starting date: September 2014
Last updated: September 5, 2014

Page last updated: August 23, 2015

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