Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Unconsciousness

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphosarcoma

Primary Central Nervous System Lymphoma

B-cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Amino Acids

Methotrexate

Rituximab

Vincristine

Lenalidomide

Ibrutinib

Procarbazine

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Lenalidomide in association with R-MPV as a targeted induction treatment

Ibrutinib in association with R-MPV as a targeted induction treatment

Patients will receive 4 cycles of induction chemotherapy with R-MPV + Lenalidomide using the Maximum Tolerated Dose (MTD) of Lenalidomide and Ibrutinib as determined in the phase-Ib part of the study.

Patients will receive 4 cycles of induction chemotherapy with R-MPV + Ibrutinib, using the Maximum Tolerated Dose (MTD) of Lenalidomide and Ibrutinib as determined in the phase-Ib part of the study.

Carole SOUSSAIN, MD

LYNDA CORVI

Caroline DELETTE, MD

Jérôme PAILLASSA, MD

Sophie BERNARD, MD

Adrien CHAUCHET, MD

Anna SCHMITT, MD

Gandhi DAMAJ, MD

Gandhi DAMAJ, PhD

Cécile MOLUCON-CHABROT, MD

Guido AHLE, MD

Guido AHLE Guido AHLE, MD

Louise ROULIN, MD

Rémy Rémy GRESSIN, MD

Rémy GRESSIN, MD

Franck MORSCHHAUSER, PhD

Julie ABRAHAM, MD

ABRAHAM Julie, MD

Hervé GHESQUIERES, MD

Hervé GHESQUIERES, Phd

Olivier CHINOT, MD

Luc TAILLANDIER, PhD

Thomas GASTINNE, MD

Frédéric PEYRADE, MD

Agathe WAULTIER-RASCALOU, MD

Carole Soussain, MD

Lise WILLEMS, MD

Caroline HOUILLIER, MD

Vincent DELWAIL, MD

Thierry LAMY De La CHAPELLE, PhD

Thierry Thierry LAMY De La CHAPELLE, PhD

Fabrice JARDIN, PhD

Marie DE CHARETTE, MD

Luc-Mathieu FORNECKER, MD

Lucie Obéric, MD

Emmanuel GYAN, MD

Steven LE GOUILL, PhD

This study is to improve the first-line induction chemotherapy, by combining either Ibrutinib, or Lenalidomide, to a conventional immuno- chemotherapy of R-MPV type (Rituximab-Methotrexate-Procarbazine-Vincristine). This is a randomized Phase II trial, preceded by a dose escalation phase Ib. The objective of the phase Ib is to rule out any limiting toxicity of the new treatment associations, and to determine the recommended dose of Lenalidomide and Ibrutinib to be used in the phase II. In the phase II study, patients will receive 4 cycles of R-MPV + Lenalidomide or 4 cycles of R-MPV + Ibrutinib. The therapeutic response will be evaluated after the 2nd and the 4th cycle. Patients in good therapeutic response will proceed to the consolidation phase with Autologous Stem Cell Transplantation (ASCT).

The objective of this proposal is to test the feasibility and efficacy of two targeted induction chemotherapies obtained by adding either Lenalidomide or Ibrutinib to a standard Rituximab-High Dose (HD) Methotrexate (MTX) based induction chemotherapy regimen. The R-MPV regimen is chosen as the backbone chemotherapy because of its wide use with robust reproducible results and a good and manageable toxicity profile

LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)

LOC-R01: Randomized Phase IB/II Study of Escalating Doses of Lenalidomide and Ibrutinib in Association With R-MPV as a Targeted Induction Treatment for Patients Aged 18 to 60 (up to 65 for Phase II) With a Newly Diagnosed Primary Central Nervous System Lymphoma

Sponsor will share de-identified data sets generated under the project will be disseminated in accordance with Institut Curie policies.

Occurrence of a Dose Limiting Toxicity (DLT) during the first cycle of treatment for each treatment arm. The phase Ib is a 3+3 dose escalation design

The primary endpoint for the phase II part of the study is the Complete Response (CR) rate including unconfirmed CR (CR+uCR) at the end of the 4 cycles of induction therapy. Assessment of response will be based on the International Primary Central Nervous System Lymphoma Collaborative Group (IPCG)

Assessment of response will be based on the International Primary Central Nervous System Lymphoma Collaborative Group (IPCG)

Overall Survival (OS) will be calculated from the date of randomization to the date of death, whatever the cause. Patients alive at the date of last contact will be censored at this date.

Progression-Free Survival (PFS) will be calculated from the date of randomization to the date of progression or death (if the patient does not progress). Patients alive without progression at the date of last contact will be censored at this date

Toxicity of treatment induction or ASCT will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0) whenever possible and described by system organ class, preferred term

The percentage of patients who will receive ASCT will be presented

National Cancer Institute, France

Institut Curie

Behaviors and Mental Disorders

Brain Neoplasms

Brain Diseases

Central Nervous System Diseases

Quality of Life

eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.

eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.

Questionnaires Only Control: Family caregivers of primary brain tumor patients.

Questionnaires Only Control: Family caregivers of secondary brain tumor patients.

Participants in the intervention group will then be given a tablet loaded with the eSNAP application and asked to create a visualization of their social networks. Upon completion, participants will be asked to review their ecomaps and complete the user experience questionnaire.

eSNAP

Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.

Questionnaires

Maija Reblin, Ph.D.

The purpose of the study is to learn more about neuro-oncology caregivers' quality of life and how friends and families help neuro-oncology cancer caregivers at different times during treatment.

Former Aim 1: Refine eSNAP data-gathering and visualization prototypes based on evaluations of user experience, including usability, satisfaction and applicability. The refining process was completed at the University of Utah.

Aim 2: Test the feasibility of implementing eSNAP in a neuro-oncology clinical setting and collect preliminary effectiveness data of eSNAP on Family Caregiver outcomes, including quality of life and stress, and mediators (Family Caregiver social support utilization and burden). The feasibility process will take place at Moffitt Cancer Center.

This study will be a 2x2 longitudinal design. Caregivers of primary brain tumor patients will be compared to caregivers of patients with secondary brain tumors (brain metastases) to determine if there is something unique about the cancer-specific duties of primary versus secondary brain tumors that could impact the effectiveness of the eSNAP application. An intervention group will be compared to a control group for both types of caregivers. Participants will be randomized 2:1 for the intervention and control. All caregivers will be followed for 6 weeks and will be asked to complete questionnaires at 3 time points; caregivers in the intervention group will also be asked to use the eSNAP application at time 1, which will be available to them for the duration of the study.

Refining and Testing the Electronic Social Network Assessment Program (eSNAP)

Feasibility 1: Recruitment rates per group.

Feasibility 2: Retention rates per group.

Although not reaching adequate power to detect differences, planned analysis will allow investigators to estimate effect size of eSNAP at baseline as well as the effect of cancer type. (Power analysis conducted in G\*Power for ANOVA using effect size 0.2 a=.05 for 3 groups for power of 0.80 requires a sample of 246.) ANOVA will be conducted to determine if groups vary on stress and quality of life at baseline. Growth-curve analysis will be used to identify potential preliminary differences in the eSNAP group over time.

Chi square and generalized linear model (GLM) will be used to analyze utilization of support services differences.

Incidence of clinic disruption per participant group.

Chi square and generalized linear model (GLM) will be used to analyze trends in satisfaction or time spent on ecomapping/eSNAP.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)	NCT04446962	Lymphoma, Large... Central Nervous...	Lenalidomide Ibrutinib	18 Years - 65 Years	Institut Curie
Refining and Testing the Electronic Social Network Assessment Program (eSNAP)	NCT03026699	Brain Cancer	eSNAP Questionnaires	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Refining and Testing the Electronic Social Network Assessment Program (eSNAP)	NCT03026699	Brain Cancer	eSNAP Questionnaires	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for nervous system