Health TrialsbyHealthPanel

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

ConditionHematologic Malignancies
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing InnoCare Pharma Tech Co., Ltd.

About this trial

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and ≤ 80 years.

Having an indication for treatment that meets the criteria for iwCLL 2018

Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria.

Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months.

Disqualifiers

Central nervous system involvement.

Concomitant Richter transformation.

Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis.

Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days.

Trial design

Design model

Single group

Treatments tested in this trial

  • ICP-248

    Drug

    Eligible patients will receive ICP-248 orally as per the protocol，once daily for every 28 days as one treatment cycle

  • Orelabrutinib

    Drug

    Eligible patients will receive Orelabrutinib orally as per the protocol，once daily for every 28 days as one treatment cycle

Treatment groups

226 Participants
are divided into 1 treatment group
Group A: ICP-248 in combination with OrelabrutinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria

Time frame
Up to 6 years
2

Changes from baseline in pulse.

Time frame
Up to 6 years
3

Changes from baseline in blood pressure.

Time frame
Up to 6 years
4

Changes from baseline in ECG QRS interval.

Time frame
Up to 6 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing InnoCare Pharma Tech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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