OncoMatch/Clinical Trials/NCT06378138
ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)
Is NCT06378138 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including ICP-248 and Orelabrutinib for hematologic malignancies.
Treatment: ICP-248 · Orelabrutinib — Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic treatment
Exception: emergency pretreatment to reduce white blood cells and relieve leukostasis
Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis
Cannot have received: allogeneic stem cell transplantation
History of allogeneic stem cell transplantation
Lab requirements
Blood counts
adequate hematologic function
Kidney function
adequate renal function
Liver function
adequate hepatic function
Cardiac function
adequate cardiac function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06378138 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify