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Pyrimidine analogues

Venetoclax + Chemotherapy for Acute Myeloid Leukemia (Venetoclax AML Trial)

Phase 1
Recruiting
Led By Ioannis Mantzaris, MD
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
Must not have
Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
Subject has known active CNS involvement with AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 6 years
Awards & highlights
No Placebo-Only Group

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.
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).
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My leukemia is of a specific type known as acute promyelocytic.
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My acute myeloid leukemia has spread to my brain or spinal cord.
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My white blood cell count is above 25 x 10⁹/L.
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My heart's pumping ability is significantly reduced.
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I have not had a heart attack or severe heart issues in the last 6 months.
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I do not have an uncontrolled HIV or active Hepatitis B or C infection.
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I have a condition that affects how I swallow or absorb drugs taken by mouth.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Duration of response
Event-free survival
Hematologic response rate
+3 more
Other study objectives
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
9%
Hemorrhage with Grade 3 or 4 Platelets
8%
Anorexia
7%
Fever
6%
Nausea
5%
Fatigue
5%
Dyspnea
5%
Rash
4%
Bilirubin Increased
4%
Hypoxia
3%
Stomatitis
3%
ALT Increased
3%
Hypotension
3%
Infection w/o neutropenia
3%
Hypokalemia
2%
hyperglycemia
2%
Colitis
2%
Pain-other
2%
Epistaxis
2%
Hypoalbuminemia
2%
Diarrhea w/o prior colostomy
2%
Syncope
2%
Typhlitis
2%
Hypertension
2%
DIC
2%
Vomiting
2%
Petechiae
2%
Hyponatremia
2%
Pneumonitis/pulmonary infiltrates
1%
Confusion
1%
Dysphagia
1%
Abdominal Pain
1%
Wound-infectious
1%
Renal Failure
1%
AST increased
1%
Tumor Lysis Syndrome
1%
Thrombosis
1%
Arthralgia
1%
CNS hemorrhage
1%
Ocular-Other
1%
Pericardial Effusion/Pericarditis
1%
ARDS
1%
Pruritus
1%
Diarrhea
1%
Bone, pain
1%
Proctitis
1%
Lymphopenia
1%
Hemoptysis
1%
Vaginal Bleeding
1%
Hypocalcemia
1%
Hypophosphatemia
1%
Dizziness/Lightheadedness
1%
Hallucinations
1%
Anxiety/Agitation
1%
Headache
1%
Rectal or Perirectal Pain
1%
Pleural effusion
1%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Daunorubicin (Induction Therapy)
High Dose Daunorubicin (Induction Therapy)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~5040
Cytarabine
2016
Completed Phase 3
~3330

Find a Location

Who is running the clinical trial?

Ioannis MantzarisLead Sponsor
AbbVieIndustry Sponsor
1,033 Previous Clinical Trials
522,179 Total Patients Enrolled
Ioannis Mantzaris, MDPrincipal InvestigatorMontefiore Medical Center

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
~60 spots leftby Dec 2028
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