Study of BGB-11417 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

BeiGene

Status and phase: Active, not recruiting; Phase 2

Conditions: Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Small Lymphocytic Lymphoma; Lymphoma; Leukemia; Relapsed Chronic Lymphocytic Leukemia

Treatments: Drug: BGB-11417

Study type: Interventional

Funder types: Industry

Identifiers

NCT05479994

BGB-11417-202

CTR20222085 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of BGB-11417 in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

1. Participants with a histologically confirmed diagnosis of CLL/SLL based on the International Workshop on CLL (iwCLL) criteria:

   1. Treatment intolerance or failure during or after treatment with chemoimmunotherapy (CIT) and BTK inhibitors (BTKi) or
   2. Treatment intolerance or failure during or after treatment with BTKi for CIT-ineligible participants as assessed by the investigator.

2. Participants who require treatment based on the iwCLL 2018 criteria

3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2

4. Life expectancy of > 6 month

Key Exclusion Criteria

1. Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or low risk (Gleason score ≤ 6) localized prostate cancer
2. Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results
3. A known history of or currently suspected Richter's syndrome
4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or prior chimeric cell therapy (unless ≥ 6 months after cell infusion)
5. Prior allogeneic stem cell transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment Arm

Experimental group

Description:

Participants will receive BGB-11417 orally until disease progression, intolerable toxicity, or other scenarios specified in the protocol

Treatment:

Drug: BGB-11417

Sponsor of this trial

Lead Sponsor

BeiGene