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Enzyme

Pegcrisantaspase + Venetoclax for Acute Myeloid Leukemia

Q: Does this research endeavor have any additional capacity for enrollees?

Affirmative. Clinicaltrials.gov data elucidates that this medical trial, first published on March 10th 2021, is currently seeking participants. A total of 30 individuals must be sourced from a single site for the study to move forward.

Q: What is the objective of this clinical experiment?

This clinical trial will run for an entire year, with the primary endpoint being the rate of treatment-emergent adverse events (TEAE). Additionally, investigators will be assessing overall incidence and severity of AEs, composite complete remission rate, and event-free survival.

Q: Has the FDA officially sanctioned Venetoclax and pegcrisantaspase?

Our team at Power judged the safety profile of Venetoclax and pegcrisantaspase, to be a score 1 on our scale from 1-3. This is due to this being Phase 1 trial with only minimal clinical data supporting its efficacy or security.

Q: What experimental evidence exists to demonstrate the effectiveness of Venetoclax combined with pegcrisantaspase?

At this moment, there are 220 clinical studies regarding Venetoclax and pegcrisantaspase with 28 in the third phase of trials. Most of these experiments originate from Boston yet can be found at 7199 sites around the world.

Q: What is the upper limit of patients that can participate in this clinical trial?

Affirmative. Clinicaltrials.gov supports the notion that this clinical trial is actively searching for volunteers, which was initially posted on March 10th 2021 and modified most recently on May 17th 2022. The study necessitates a total of 30 test subjects from one location to partake in the research.

Phase 1

Waitlist Available

Led By Vu Duong, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year (after 12 cycle's treatment)

Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat relapsed or refractory acute myeloid leukemia. The goal is to find the maximum tolerated doses and/or biologically active doses of the drugs.

Who is the study for?

Adults diagnosed with relapsed or refractory acute myeloid leukemia (R/R AML) who have tried up to three prior treatments. Suitable for those with certain genetic mutations if they've had specific inhibitors, and post stem cell transplant patients without severe graft versus host disease. Must not have other active cancers, recent investigational drug use, or uncontrolled illnesses.Check my eligibility

What is being tested?

The trial is testing the combination of two drugs: Venetoclax and pegcrisantaspase (Ven-PegC), in adults with R/R AML to find safe dosage levels and assess tolerability. It aims to determine the maximum doses that do not cause unacceptable side effects.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, liver abnormalities, pancreatitis, blood clotting issues like deep vein thrombosis or stroke, infections due to weakened immune system response, and possibly others related to organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My AML has returned or didn't respond to 1-3 treatments. I've tried FLT3 or IDH inhibitors if applicable.

Select...

I am 18 years old or older.

Select...

My AML diagnosis is confirmed and fits specific genetic features.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I had a stem cell transplant over 30 days ago, no serious GVHD, and stopped immunosuppressants for 10+ days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year (after 12 cycle's treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year (after 12 cycle's treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year (after 12 cycle's treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of regimen limiting toxicities (RLTs)

Incidence of treatment-emergent adverse events (TEAE)

Secondary outcome measures

Achievement of MRD <0.02% within 2 cycles of treatment with Ven-PegC

Event-free Survival (EFS)

Overall Survival (OS)

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 600mg Venetoclax, 1000 IU/m ² of PegcrisantaspaseExperimental Treatment1 Intervention

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)

Group II: Cohort 400mg of Venetoclax, 750 IU/m ² of PegcrisantaspaseExperimental Treatment1 Intervention

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)

Group III: Cohort 400mg of Venetoclax, 500 IU/m ² of PegcrisantaspaseExperimental Treatment1 Intervention

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)

Group IV: Cohort 400mg of Venetoclax, 1000 IU/m² of PegcrisantaspaseExperimental Treatment1 Intervention

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)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,629 Total Patients Enrolled

Vu Duong, MDPrincipal InvestigatorUniversity of Maryland, Baltimore

2 Previous Clinical Trials

8 Total Patients Enrolled

Ashkan Emadi, M.D.,Ph.D.Principal Investigator - University of Maryland, Baltimore

University of Maryland Medical Center, University of Maryland Physicians PA

1 Previous Clinical Trials

6 Total Patients Enrolled

Media Library

Pegcrisantaspase (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT04666649 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Cohort 400mg of Venetoclax, 1000 IU/m² of Pegcrisantaspase, Cohort 600mg Venetoclax, 1000 IU/m ² of Pegcrisantaspase, Cohort 400mg of Venetoclax, 500 IU/m ² of Pegcrisantaspase, Cohort 400mg of Venetoclax, 750 IU/m ² of Pegcrisantaspase

Acute Myeloid Leukemia Clinical Trial 2023: Pegcrisantaspase Highlights & Side Effects. Trial Name: NCT04666649 — Phase 1

Pegcrisantaspase (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04666649 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have any additional capacity for enrollees?

"Affirmative. Clinicaltrials.gov data elucidates that this medical trial, first published on March 10th 2021, is currently seeking participants. A total of 30 individuals must be sourced from a single site for the study to move forward."

Answered by AI

What is the objective of this clinical experiment?

"This clinical trial will run for an entire year, with the primary endpoint being the rate of treatment-emergent adverse events (TEAE). Additionally, investigators will be assessing overall incidence and severity of AEs, composite complete remission rate, and event-free survival."

Answered by AI

Has the FDA officially sanctioned Venetoclax and pegcrisantaspase?

"Our team at Power judged the safety profile of Venetoclax and pegcrisantaspase, to be a score 1 on our scale from 1-3. This is due to this being Phase 1 trial with only minimal clinical data supporting its efficacy or security."

Answered by AI

What experimental evidence exists to demonstrate the effectiveness of Venetoclax combined with pegcrisantaspase?

"At this moment, there are 220 clinical studies regarding Venetoclax and pegcrisantaspase with 28 in the third phase of trials. Most of these experiments originate from Boston yet can be found at 7199 sites around the world."

Answered by AI

What is the upper limit of patients that can participate in this clinical trial?

"Affirmative. Clinicaltrials.gov supports the notion that this clinical trial is actively searching for volunteers, which was initially posted on March 10th 2021 and modified most recently on May 17th 2022. The study necessitates a total of 30 test subjects from one location to partake in the research."

Answered by AI

Recent research and studies

BloodJournal

Venetoclax Combined with Decitabine or Azacitidine in Treatment-naive, Elderly Patients with Acute Myeloid Leukemia

DiNardo, Courtney D., Keith Pratz, Vinod Pullarkat, Brian A. Jonas, Martha Arellano, Pamela S. Becker, Olga Frankfurt, et al.. 2019. “Venetoclax Combined with Decitabine or Azacitidine in Treatment-naive, Elderly Patients with Acute Myeloid Leukemia”. Blood. American Society of Hematology. doi:10.1182/blood-2018-08-868752.

Experimental HematologyJournal

Inhibition of Glutaminase Selectively Suppresses the Growth of Primary Acute Myeloid Leukemia Cells with IDH Mutations

Emadi, Ashkan, Sung Ah Jun, Takashi Tsukamoto, Amir T. Fathi, Mark D. Minden, and Chi V. Dang. 2014. “Inhibition of Glutaminase Selectively Suppresses the Growth of Primary Acute Myeloid Leukemia Cells with IDH Mutations”. Experimental Hematology. Elsevier BV. doi:10.1016/j.exphem.2013.12.001.

erwiniaJournal

erwinia Asparaginase After Allergy to e. Coli Asparaginase in Children with Acute Lymphoblastic Leukemia

Vrooman, Lynda M., Jeffrey G. Supko, Donna S. Neuberg, Barbara L. Asselin, Uma H. Athale, Luis Clavell, Kara M. Kelly, et al.. 2009. “erwinia Asparaginase After Allergy to e. Coli Asparaginase in Children with Acute Lymphoblastic Leukemia”. Pediatric Blood & Cancer. Wiley. doi:10.1002/pbc.22225.

BloodJournal