NCT02603445

Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL

Completed Phase 1 Last updated 24 February 2020

What this trial tests

Phase 1 trial testing BCL201 in Follicular Lymphoma, Mantle Cell Lymphoma in 20 participants. Completed in 10 July 2018.

Timeline

16 November 2015

Primary endpoint
10 July 2018

10 July 2018

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	16 November 2015
Primary completion	10 July 2018
Estimated completion	10 July 2018
Sites	7 locations across Austria, France, United States, Germany

Drugs / interventions tested

• BCL201 — full drug profile →
• Idelalisib — full drug profile →

Conditions studied

• Follicular Lymphoma, Mantle Cell Lymphoma — all drugs for Follicular Lymphoma, Mantle Cell Lymphoma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Follicular Lymphoma, Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.

Approximately 65 patients are to be enrolled.

The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib. In addition Bayesian regression models will be used to estimate the dose-exposure relationships for both BCL201 and idelalisib in order to guide the escalation steps. A Bayesian method for the expansion part will be used for the primary activity objective.

The study data will be analyzed and reported based on all patients' data of the escalation and expansion part.

Publications & conference data

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

1. Targeting apoptosis in cancer therapy.
   Carneiro BA, El-Deiry WS. · · 2020 · cited 1823× · PMID 32203277 · DOI 10.1038/s41571-020-0341-y
2. BCL-2 family isoforms in apoptosis and cancer.
   Warren CFA, Wong-Brown MW, Bowden NA. · · 2019 · cited 498× · PMID 30792387 · DOI 10.1038/s41419-019-1407-6
3. Tumor biomarkers for diagnosis, prognosis and targeted therapy.
   Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2
4. Apoptosis: A Comprehensive Overview of Signaling Pathways, Morphological Changes, and Physiological Significance and Therapeutic Implications.
   Mustafa M, Ahmad R, Tantry IQ, Ahmad W, et al · · 2024 · cited 264× · PMID 39594587 · DOI 10.3390/cells13221838
5. Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
   Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5
6. The BCL2 family: from apoptosis mechanisms to new advances in targeted therapy.
   Vogler M, Braun Y, Smith VM, Westhoff MA, et al · · 2025 · cited 104× · PMID 40113751 · DOI 10.1038/s41392-025-02176-0
7. BCL-2 family deregulation in colorectal cancer: potential for BH3 mimetics in therapy.
   Ramesh P, Medema JP. · · 2020 · cited 91× · PMID 32335811 · DOI 10.1007/s10495-020-01601-9
8. S55746 is a novel orally active BCL-2 selective and potent inhibitor that impairs hematological tumor growth.
   Casara P, Davidson J, Claperon A, Le Toumelin-Braizat G, et al · · 2018 · cited 85× · PMID 29732004 · DOI 10.18632/oncotarget.24744