DZD8586 compared with doctor’s choice treatments for relapsed/refractory CLL/SLL

A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This trial will test whether the oral drug DZD8586 works better than commonly chosen treatments for adults with relapsed or refractory CLL/SLL.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dizal Pharmaceuticals (industry)
• Locations: 2 sites (Nanjing, Jiangsu and 1 other locations)
• Trial ID: NCT07139873 on ClinicalTrials.gov

What this trial studies

This is a phase 3, open-label, randomized, multicenter trial randomizing about 250 adults with relapsed or refractory CLL/SLL to receive DZD8586 or investigator's choice therapy (options include bendamustine, idelalisib, or rituximab). The primary endpoint is progression-free survival reviewed by an independent review committee, with safety and tolerability monitored across arms. Key eligibility includes age ≥18, ECOG 0–2, adequate marrow and organ function, and no Richter transformation or CNS involvement. The study is being conducted at major hospitals in Nanjing and Tianjin, China.

Who should consider this trial

Good fit: Adults (≥18) with relapsed or refractory CLL/SLL who require further therapy, have ECOG 0–2, adequate organ and marrow function, and agree to contraception rules are the intended participants.

Not a fit: Patients with Richter transformation, CNS involvement, uncontrolled infection, significant cardiovascular disease, inability to swallow or absorb oral medication, or who are breastfeeding are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, DZD8586 could extend progression-free survival or provide an alternative tolerable option for patients whose CLL/SLL returned after prior treatments.

How similar studies have performed: Other targeted agents and rituximab- or idelalisib-containing regimens have shown benefit in relapsed CLL/SLL, but DZD8586 itself is a novel agent now being tested in phase 3.

Eligibility criteria

Inclusion Criteria:

1. Male and female participants ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
4. Adequate bone marrow reserve and organ system functions.
5. Participants willing to comply with contraceptive restrictions.

Exclusion Criteria:

1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment.
2. Known or suspected Richter transformation.
3. Known or suspected CNS involvement.
4. Previous or current therapy and comedications meet exclusion criteria.
5. Participants with major cardiovascular disease, active infection, malignancy or uncontrolled systemic disease.
6. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
7. Women who are breast feeding.
8. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Where this trial is running

Nanjing, Jiangsu and 1 other locations

• First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital — Nanjing, Jiangsu, China (RECRUITING)
• National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Frank Fang

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma