CompletedPhase 1

APG-2575 Single Agent or in Combination With Ibrutinib or Rituximab in Patients With Waldenström Macroglobulinemia

United States46 participantsStarted 2021-05-30

Plain-language summary

Phase Ib/II study of safety, tolerability, efficacy and PK of APG-2575 as a single agent or in combination with other therapeutic agents including ibrutinib or rituximab.

Who can participate

Age range18 Years – 95 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Local confirmed clinicopathological diagnosis of WM in accordance with the consensus panel of the Second International Workshop on WM (Owen 2003).
✓. WM patients with symptomatic and measurable disease (defined as presence of serum immunoglobulin M (IgM)\>0.5g/dL), requiring treatment as per mSMART guidelines (Kyle 2003): with B symptoms (fever, night sweats, fatigue, night sweats weight loss), progressive lymphadenopathy or splenomegaly, anemia (hemoglobin value of \<10 g/dL) or platelet count \<100\*109/L due to marrow infiltration. Complications such as hyperviscosity syndrome, symptomatic sensorimotor peripheral neuropathy due to WM, systemic amyloidosis related to WM, renal insufficiency related to WM, or symptomatic cryoglobulinemia may also be indications for therapy.
✓. For Arm A only: Have received at least one prior therapy for WM. Patient must have either failed (defined as progressing while on or within 6 months of treatment with ibrutinib treatment) or intolerant to ibrutinib.
✓. For Arm B only: Previously untreated WM.
✓. For Arm C only: Have received at least one prior therapy, relapsed or refractory WM.
✓. Adequate hematologic function defined as:
✓. ANC ≥1.0 x 109/L independent of growth factor support within 7 days of the first dose with study drug.
✓. Hemoglobin ≥9 g/dL without transfusion or growth factor support within 7 days of the first dose of study drug.

Exclusion criteria

✕. For Arm A only: Patients who have never been treated with ibrutinib.
✕. For Arm B only: Patients who have previously received any treatment for WM.
✕. For Arm C only:
✕. Patients who have previously been treated with ibrutinib or other BTK inhibitor.
✕. Disease that is refractory to the last prior rituximab based-therapy defined as either Relapse after the last rituximab-based therapy (\<12 months since last dose of rituximab), OR Failure to achieve at least a MR after the last rituximab-based therapy.
✕. Rituximab treatment within the last 12 months before the first dose of study drug.
✕. Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab.
✕. Patients with central nervous system involvement (Bing-Neel syndrome), active infection (including active hepatitis B or C virus infection, known human immunodeficiency virus (HIV) positive) or any other serious (unresolved) medical condition.

What they're measuring

Primary Toxicity Endpoint: dose limiting toxicity (DLT)

Timeframe: 42 days

Maximally tolerated dose (MTD)

Timeframe: 42 days

Trial details

NCT IDNCT04260217

SponsorAscentage Pharma Group Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-05

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