Pegcrisantaspase in Combination With Venetoclax for Treatment of Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)

Conditions

• Relapsed or Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Venetoclax and pegcrisantaspase — DRUG
  Therapeutic

Study Details

Evaluate the safety and tolerability of pegcrisantaspase in combination with venetoclax (Ven-PegC) and estimate the maximum tolerated doses and/or biologically active doses of Ven-PegC in patients with relapsed or refractory acute myeloid leukemia (R/R AML)

Key Dates

First listed

Dec 14, 2020

Start date

Mar 10, 2021

Status verified

Oct 2025

Primary completion

Sep 1, 2024

Completion

May 23, 2025

Study Design

Enrollment

27 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 400mg of Venetoclax, 500 IU/m ² of Pegcrisantaspase
  The subject will take 400mg of Venetoclax every day as a pill by mouth and a dose of 500 IU/m ² of Pegcrisantaspase in an IV every 14 days ( per cycle)
• Experimental: Cohort 400mg of Venetoclax, 750 IU/m ² of Pegcrisantaspase
  The subject will take 400mg of Venetoclax every day as a pill by mouth and a dose of 750 IU/m ² of Pegcrisantaspase in an IV every 14 days ( per cycle)
• Experimental: Cohort 400mg of Venetoclax, 1000 IU/m² of Pegcrisantaspase
  The subject will take 400mg of Venetoclax every day as a pill by mouth and a dose of 1000 IU/m² of Pegcrisantaspase in an IV every 14 days ( per cycle)
• Experimental: Cohort 600mg Venetoclax, 1000 IU/m ² of Pegcrisantaspase
  The subject will take 600mg of Venetoclax every day as a pill by mouth and a dose of 1000 IU/m ² of Pegcrisantaspase in an IV every 14 days ( Per cycle)

Primary Outcome Measure

Incidence of regimen limiting toxicities (RLTs) [ Time Frame: One year (after 12 cycle's treatment) ]

Locations (1)

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