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RecruitingLast updated: 15 August 2023

AGAVE-201: This phase II trial is trying to understand how safe and effective targeted therapy (axatilimab) is at three different dose levels in people with recurrent or refractory active chronic Graft versus Host diseaseAGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

Clinical summary

Summary

This is a randomised, open-label trial with three active comparator arms each evaluating different dose levels of axatilimab. Participants in Active Comparator Arm 1 will receive axatilimab via intravenous infusions (IV) at a dose of 0.3mg/kg Q2W. Participants in Active Comparator Arm 2 will receive axatilimab via IV at a dose of 1mg/kg Q2W. Participants in Active Comparator Arm 3 will receive axatilimab via IV at a dose of 3mg/kg Q4W.

Conditions

This trial is treating patients with chronic Graft versus Host disease.

Cancer

Blood Cancers Blood

Age

People2+

Phase

II

Trial Acronym

AGAVE-201

More information

Trial Identifiers

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Commercial Sponsor

Syndax Pharmaceuticals

Scientific Title

AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

Eligibility

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

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