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NCT01403636 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lymphoma, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
167
Enrollment target
20
Study locations

NCT01403636: Completed Phase 2 study of Lymphoma, sponsored by Sanofi.

NCT01403636 is a Phase 2 study of Lymphoma that has completed, run by Sanofi. The registered enrollment target is 167 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01403636, a Phase 2 study of Lymphoma, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
167 participants
Enrollment target
20
Study locations

Study 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

Conditions Studied

Lymphoma

Interventions

  • DRUG SAR245409

Study Locations (20)

Other

  • Investigational Site Number 036002 - Clayton
  • Investigational Site Number 036001 - Hobart
  • Investigational Site Number 036005 - Kingswood
  • Investigational Site Number 036003 - Perth
  • Investigational Site Number 056003 - Brussels
  • Investigational Site Number 056002 - Ghent
  • Investigational Site Number 056001 - Leuven
  • Investigational Site Number 250002 - Montpellier

Kentucky

  • Investigational Site Number 840013 - Lexington
  • Investigational Site Number 840007 - Paducah

California

  • Investigational Site Number 840012 - Los Angeles

Florida

  • Investigational Site Number 840104 - Fort Meyers

Georgia

  • Investigational Site Number 840006 - Augusta

Illinois

  • Investigational Site Number 840011 - Maywood

Kansas

  • Investigational Site Number 840010 - Kansas City

Massachusetts

  • Investigational Site Number 840004 - Boston

Trial Details

FieldValue
Enrollment Target 167 participants
Start Date 2011-10
Est. Completion 2014-09
Phase Phase 2
Sanofi

713 total trials

What the finished NCT01403636 record still lists

NCT01403636 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (65% lower).

The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which SAR245409 is the first listed.

NCT01403636 names 20 study sites across 12 states, led by Other, Kentucky, California.

Frequently Asked Questions

What is clinical trial NCT01403636 about?

NCT01403636 is a clinical study titled "A Study of Investigational SAR245409 in Patients With Certain Lymphoma or Leukemia". 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 lymphoc...

What is the current status of trial NCT01403636?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 167 participants. The study started on 2011-10. Estimated completion is 2014-09.

What conditions does trial NCT01403636 study?

This clinical trial studies the following conditions: Lymphoma.

What interventions are being tested in trial NCT01403636?

The interventions under investigation include: SAR245409 (DRUG).

Who is sponsoring clinical trial NCT01403636?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01403636 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01403636's enrollment target sits among peer trials

167 56th of 299 higher than 244 of 299 other Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01403636, the US trial registry maintained by the National Library of Medicine. NCT01403636 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.