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COMPLETEDPHASE2

A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

A Phase 2 Study of SAR245409 in Patients With Relapsed or Refractory Mantle Cell Lymphoma, Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Diffuse Large B Cell Lymphoma

NCT01403636•Sanofi

View on ClinicalTrials.gov

Summary

Primary Objective: \- To evaluate the efficacy of SAR245409 as determined by the objective response rate (ORR) in patients with 1 of following relapsed or refractory lymphoma or leukemia subtypes: mantle cell lymphoma (MCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), or diffuse large B cell lymphoma (DLBCL) Secondary Objectives: * To assess duration of response, progression free survival (PFS), and proportion of patients with PFS at 6 months (24 weeks) in patients with either MCL, FL, CLL/SLL or DLBCL treated with SAR245409 * To evaluate the safety and tolerability of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL * To further characterize the plasma pharmacokinetics (PK) of SAR245409 in patients with MCL, FL, CLL/SLL or DLBCL

Detailed Description

There is a 21 day screening period followed by 28 day cycles. Patients will continue to receive SAR245409 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 30 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Tissue from an archived or fresh tumor sample
•A peripheral blood buffy coat sample is required for CLL/SLL.
•Patient has mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL)/SLL or diffuse large B cell lymphoma
•Patient \> or = 18 years old
•Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2. Patients with DLBCL will have ECOG \< or = 1
•Adequate white blood cells and hemoglobin
•Good kidney and liver function
•Fasting glucose \< 160 mg/dL
•No other malignancy
•Use of adequate birth control
+5 more criteria

Exclusion Criteria

•Treatment with cytotoxic chemotherapy, biologic agents, investigational therapies within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks of study enrollment
•Treatment with a small-molecule kinase inhibitor within 2 weeks, or 5 half lives of the drug or its active metabolites (whichever is longer) of study enrollment
•Prior treatment with a PI3K, mTOR, or Akt inhibitor. Prior treatment of MCL with temsirolimus is permitted in patients enrolled from countries where it is licensed for this indication.
•Radiation therapy within 2 weeks of enrollment
•Autologous stem cell transplantation within 16 weeks of enrollment

Locations (30)

Investigational Site Number 840012

Los Angeles, California, United States

Investigational Site Number 840104

Fort Meyers, Florida, United States

Investigational Site Number 840006

Augusta, Georgia, United States

Investigational Site Number 840011

Maywood, Illinois, United States

Investigational Site Number 840010

Kansas City, Kansas, United States

Investigational Site Number 840013

Lexington, Kentucky, United States

Investigational Site Number 840007

Paducah, Kentucky, United States

Investigational Site Number 840004

Boston, Massachusetts, United States

Investigational Site Number 840015

St Louis, Missouri, United States

Investigational Site Number 840014

Canton, Ohio, United States

Key Dates

Start Date

October 1, 2011

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

March 17, 2016

Enrollment

167

ACTUAL participants

Conditions

Lymphoma

Interventions

SAR245409

DRUG

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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RECRUITINGPHASE1

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

U69-CART-Cells For R/R T-ALL