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

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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