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Pyrimidine analogues

Venetoclax + Chemotherapy for Acute Myeloid Leukemia

Phase 1

Recruiting

Research Sponsored by Ioannis Mantzaris

Eligibility Criteria Checklist

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

Must have

Patients aged ≥ 18 to ≤ 75 years

New diagnosis of AML by WHO criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 6 years

Awards & highlights

Study Summary

This trial is testing the best dose and side effects of venetoclax when given with combination chemotherapy to treat patients with newly diagnosed acute myeloid leukemia or advanced myelodysplastic syndromes.

Who is the study for?

Adults aged 18-75 with a new diagnosis of acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), who may have had prior treatments at the investigator's discretion. Participants must be in good physical condition (ECOG ≤2), have proper kidney and liver function, and agree to use contraception. Excluded are those with certain heart conditions, active CNS AML involvement, uncontrolled infections like HIV/Hepatitis B/C, gastrointestinal absorption issues, significant medical/psychiatric history affecting study participation, extremely high white cell count or women not using effective birth control.Check my eligibility

What is being tested?

The trial is testing Venetoclax combined with intensive chemotherapy drugs Daunorubicin and Cytarabine in untreated adults with AML/MDS. It has two parts: first determining the safest dose combination (dose escalation), then expanding to more patients to compare this optimal dose against the starting dose for safety and effectiveness (dose expansion).See study design

What are the potential side effects?

Potential side effects include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk or bleeding problems; fatigue; liver dysfunction; kidney impairment; potential allergic reactions; and other drug-specific adverse effects that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have been newly diagnosed with AML according to WHO standards.

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

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My kidneys work well enough, with a creatinine clearance over 30 mL/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 6 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency and severity of adverse events (AEs)

Maximum tolerated dose of Venetoclax in combination with Daunorubicin and Cytarabine

Maximum tolerated dose of Venetoclax in combination with high dose cytarabine

Secondary outcome measures

Duration of response

Event-free survival

Hematologic response rate

+3 more

Other outcome measures

Rate of LSC eradication (exploratory objective)

Side effects data

From 2019 Phase 3 trial • 657 Patients • NCT00049517

98%

Leukopenia

98%

Thrombocytopenia

97%

Anemia

97%

Neutropenia

61%

Transfusion platelets

60%

Transfusion: PRBCS

47%

Infection w/ Gr3-4 neutropenia

37%

Febrile neutropenia

Hemorrhage with Grade 3 or 4 Platelets

Anorexia

Fever

Nausea

Dyspnea

Fatigue

Rash

Bilirubin Increased

Hypoxia

ALT Increased

Stomatitis

Hypotension

Infection w/o neutropenia

Hypokalemia

hyperglycemia

Diarrhea w/o prior colostomy

Epistaxis

Hypoalbuminemia

Pain-other

Colitis

Syncope

Typhlitis

Hypertension

DIC

Vomiting

Petechiae

Hyponatremia

Pneumonitis/pulmonary infiltrates

Dysphagia

AST increased

Abdominal Pain

Pericardial Effusion/Pericarditis

Wound-infectious

Diarrhea

ARDS

CNS hemorrhage

Confusion

Arthralgia

Tumor Lysis Syndrome

Thrombosis

Ocular-Other

Renal Failure

Pruritus

Bone, pain

Proctitis

Lymphopenia

Hemoptysis

Vaginal Bleeding

Hypocalcemia

Hypophosphatemia

Dizziness/Lightheadedness

Hallucinations

Anxiety/Agitation

Headache

Rectal or Perirectal Pain

Pleural effusion

Creatinine increased

100%

80%

60%

40%

20%

Study treatment Arm

Standard Daunorubicin (Induction Therapy)

High Dose Daunorubicin (Induction Therapy)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Venetoclax plus 7+3Experimental Treatment3 Interventions

see detailed description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daunorubicin

2013

Completed Phase 4

~4940

Cytarabine

2016

Completed Phase 3

~3310

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ioannis MantzarisLead Sponsor

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,296 Total Patients Enrolled

Media Library

Cytarabine (Pyrimidine analogues) Clinical Trial Eligibility Overview. Trial Name: NCT05342584 — Phase 1

Myelodysplastic Syndrome Research Study Groups: Venetoclax plus 7+3

Myelodysplastic Syndrome Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT05342584 — Phase 1

Cytarabine (Pyrimidine analogues) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05342584 — Phase 1

Frequently Asked Questions

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

What is the regulatory status of Daunorubicin?

"As it is still in its early stages of development, our team has rated the safety of Daunorubicin a 1 due to limited evidence backing up both efficacy and security."

Answered by AI

What is the primary purpose of this research endeavor?

"The six-year long trial seeks to discover the maximum tolerated dose of Venetoclax when combined with Daunorubicin and Cytarabine. Secondary objectives include establishing a Morphologic leukemia-free state, measuring Overall survival via Kaplan-Meier method, and calculating Duration of response from initial response date to disease progression or death."

Answered by AI

What is the cap for the amount of individuals taking part in this clinical investigation?

"That's accurate. Clinicaltrials.gov displays that this research trial is still open for recruitment, having been first published on May 25th 2022 and recently modified on July 14th 2022. A total of 99 individuals are required to participate across one location."

Answered by AI

Are patients currently enrolling in this research endeavor?

"According to the information located on clinicaltrials.gov, this research endeavour is still in search of participants. It was first advertised on May 25th 2022 and its information was last updated July 14th 2022."

Answered by AI

Are applicants younger than sixty eligible for this research endeavor?

"To participate in this medical trial, one must be aged between 18 and 75 years old."

Answered by AI

What qualifications must a participant meet in order to join this clinical research project?

"This clinical trial is enrolling 99 patients with myelodysplastic syndromes, aged between 18 and 75. The necessary entry criteria include: Adequate renal function (creatinine clearance >30 mL/min), a new diagnosis of AML according to WHO guidelines, higher risk MDS (R-IPSS>3.5) or 10% blasts or more at the discretion of the PI., ECOG Performance Status ≤2, adequate hepatic functioning without marked elevation in bilirubin levels unless due to Gilbert's disease or leukemic involvement; AST/ ALT < 3x ULN unless caused"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS

Ioannis Mantzaris 2022. "Venetoclax Plus Intensive Chemotherapy in AML and Advanced MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05342584.

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