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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2025
  • participants needed
    30
  • sponsor
    University of Maryland, Baltimore
Updated on 3 June 2022

Summary

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)

Description

This research study is a non-randomized, open-label Phase Ib clinical trial evaluating venetoclax (Ven) administered orally daily in combination with pegcrisantaspase (PegC) administered IV biweekly, as part of a 28-day treatment cycle in adult subjects with relapsed or refractory acute myeloid leukemia (R/R AML).

The trial will consist of dose escalation to evaluate the safety and tolerability of Ven-PegC and estimate the maximum tolerated doses (MTDs) and/or biologically active doses (e.g. recommended phase 2 doses [RP2Ds]) of Ven-PegC in patients with R/R AML

Venetoclax is an FDA (the U.S. Food and Drug Administration) approved drug, but this combination ( Ven-PegC) has not been approved by the FDA.

Details
Condition Relapsed or Refractory Acute Myeloid Leukemia
Treatment Venetoclax and pegcrisantaspase
Clinical Study IdentifierNCT04666649
SponsorUniversity of Maryland, Baltimore
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A histologically or pathologically confirmed diagnosis of AML based on 2016 WHO classification. Patients with Complex Karyotype AML (CK-AML) and TP53-mutated AML are eligible for this study
AML has relapsed after or is refractory to, first-line therapy, with a maximum of three prior lines of therapy. Patients whose AML has FLT3 or IDH1/IDH2 mutations should have received at least one available FLT3 or IDH1/IDH2 inhibitors
Age 18 years and older
ECOG performance status ≤ 2
Patients who have undergone allo-HSCT are eligible if they are ≥ 30 days post stem cell infusion, have no evidence of graft versus hose disease ( GVHD ) > Grade 1, and are ≥ 10 days off all immunosuppressive therapy
Previous cytotoxic chemotherapy must have been completed at least 10 days prior to day 1 of treatment on the study and all AEs (excluding alopecia, acne, rash) due to agents administered earlier should have recovered to < Grade 1. Patients with hematologic malignancies are expected to have hematologic abnormalities at study entry. These abnormalities which are thought to be primarily related to the underlying leukemia, are not considered to be toxicities (AE) and do not need to resolve to < Grade 1
All biologic agents including hematopoietic growth factors must have been stopped at least 1 week prior to day 1 of treatment on the study
Patients must have adequate organ function as defined below
Direct bilirubin ≤2X the institutional upper limit of normal (ULN) (except in patients with leukemic infiltration of the liver)
AST(SGOT)/ALT(SGPT) ≤3X ULN (except if attributable to leukemic infiltration of the liver)
Alkaline phosphatase ≤5X ULN
Creatinine Clearance (CrCl) ≥ 45 mL/min (except in patients with evidence of tumor lysis syndrome)
Patients with a history of CNS leukemia must be stable with clear CSF for > 2 months prior to day 1 of treatment (patient can receive intrathecal maintenance chemotherapy)
Female patients of childbearing potential must have a negative pregnancy test <1 week
prior to enrollment. Female patients of childbearing potential who are
Ability to understand and willingness to sign a written informed consent document
sexually active and male patients who are sexually active and have female
partners of childbearing potential must agree to use highly effective method
of contraception with their partners during exposure to study drugs and for 30
days after the last dose of study drugs

Exclusion Criteria

Patients receiving any other investigational agents, or concurrent chemotherapy or immunotherapy
Patients with acute promyelocytic leukemia (APL) confirmed with t(15;17) (i.e. FAB subtype M3 and M3 variant)
Patients with the following clinical histories are excluded
severe pancreatitis not related to cholelithiasis. Severe acute pancreatitis is defined by lipase elevation >5X ULN and with signs or symptoms
unprovoked deep venous thrombosis (DVT)
pulmonary emboli
Prior treatment with any asparaginase product. Patients who received ≤12 weeks of a BCL-2 inhibitor including venetoclax are eligible
Absolute peripheral blast > 100,000/μL. Hydroxyurea for blast count control is permitted before starting treatment and up to maximum of 10 days after starting treatment on the study. The decision to start hydroxyurea during this time is at the discretion of the treating physician
hemorrhagic or thromboembolic stroke
other malignancies requiring systemic chemotherapy, immunotherapy or targeted therapy in the last three months
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements
Pregnant women and female patients who are lactating and do not agree to stop breastfeeding
Uncontrolled active seizure
Any other clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
Active, uncontrolled infection; patients with infection under active treatment and
controlled with antibiotics are eligible
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