A Clinical Trial to Evaluate the Efficacy and Safety of TQB3909 Tablets Versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

To Evaluate the Efficacy and Safety of TQB3909 Tablets versus Investigator's Choice in the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Eligibility criteria

Qualifiers

The subject voluntarily agrees to participate in this study, signs the informed consent form, and is expected to be compliant.

Age: ≥18 years; ECOG PS score: 0-2; expected survival >3 months.

Patients with a confirmed diagnosis of CLL/SLL according to the diagnostic criteria of the revised 2018 iwCLL guidelines;

Meet at least one indication for treatment of CLL/SLL according to the revised 2018 iwCLL guidelines;

Disqualifiers

History of or concurrent other malignancies within 3 years prior to the first dose. The following two conditions are allowed: other malignancies treated with surgery alone and achieving continuous disease-free survival (DFS) of 5 years; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading lamina propria)];

History of Richter's transformation or prolymphocytic leukemia (PLL);

Known lymphoma/leukemia involvement of the central nervous system (CNS);

Prior allogeneic hematopoietic stem cell transplantation;

Trial design

Treatments tested in this trial

  • TQB3909 Tablets
  • Bendamustine Injection
  • Rituximab injection
  • Lenalidomide Capsules

Treatment groups

128 Participants
are divided into 2 treatment groups