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NCT01732861

Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma

Completed Phase 1 Last updated 20 December 2019
What this trial tests

Phase 1 trial testing CC-292 in Leukemia Lymphocytic Chronic B-Cell in 20 participants. Completed in 23 January 2019.

Timeline
28 December 2012
Primary endpoint
23 January 2019
23 January 2019

Quick facts

Lead sponsorCelgene
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date28 December 2012
Primary completion23 January 2019
Estimated completion23 January 2019
Sites11 locations across Austria, United States

Drugs / interventions tested

Conditions studied

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Leukemia Lymphocytic Chronic B-Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
    Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w
  2. Ibrutinib and novel BTK inhibitors in clinical development.
    Akinleye A, Chen Y, Mukhi N, Song Y, et al · · 2013 · cited 176× · PMID 23958373 · DOI 10.1186/1756-8722-6-59
  3. Small Molecule NF-κB Pathway Inhibitors in Clinic.
    Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
  4. Trial Watch: Lenalidomide-based immunochemotherapy.
    Semeraro M, Vacchelli E, Eggermont A, Galon J, et al · · 2013 · cited 46× · PMID 24482747 · DOI 10.4161/onci.26494
  5. The TKI Era in Chronic Leukemias.
    De Novellis D, Cacace F, Caprioli V, Wierda WG, et al · · 2021 · cited 12× · PMID 34959482 · DOI 10.3390/pharmaceutics13122201
  6. B cell receptor pathway in chronic lymphocytic leukemia: specific role of CC-292.
    Arnason JE, Brown JR. · · 2014 · cited 7× · PMID 27471698 · DOI 10.2147/itt.s37419

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Other Celgene trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing