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Antimetabolite

Venetoclax + CLAG-M for Acute Myeloid Leukemia

Q: How many participants are included in this research project?

Yes, the data posted on clinicaltrials.gov confirms that this particular medical trial is looking to enrol 20 participants at a single place of care. This research study was initially published on February 4th 2022 and has undergone revisions as recent as October 18th 2022.

Q: Is this experiment open to new participants?

Affirmative. Per the information listed on clinicaltrials.gov, this research project is presently recruiting participants; it was initially posted on February 4th 2022 and last amended October 18th 2022. The trial requires 20 volunteers to be recruited from 1 medical centre.

Q: Are there any other investigations concerning Venetoclax that have been conducted?

At present, there are 576 clinical trials assessing the efficacy of Venetoclax with 116 in their last phase. The majority of these studies take place within Toronto, however 19455 locations around the world have initiated research into this drug.

Q: Has the FDA sanctioned Venetoclax for therapeutic use?

The safety of Venetoclax has been rated at a 1 on our scale, as this is an early stage trial and there's limited data supporting its efficacy.

Q: What are the chief indications for Venetoclax?

Venetoclax is often prescribed to patients undergoing hemopoietic stem cell transplantation, but can also be of use in a variety of other situations, including bone marrow transfer, imaging diagnostics and infections.

Phase 1

Recruiting

Led By Mary-Beth M. Percival

Research Sponsored by University of Washington

Eligibility Criteria Checklist

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

Must have

Subject must have adequate renal function as demonstrated by a creatinine clearance >= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection

Eastern Cooperative Oncology Group (ECOG) =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 year

Awards & highlights

Study Summary

This trial finds the best dose of venetoclax and side effects when given with other chemotherapy drugs to treat patients with acute myeloid leukemia and high-grade myeloid neoplasms.

Who is the study for?

Adults with acute myeloid leukemia or high-grade myeloid neoplasms, including those with biphenotypic leukemia. Participants must have adequate kidney and liver function, an ECOG score of 2 or less (meaning they can perform light activities), and a heart ejection fraction of at least 45%. They should understand the trial and consent to it. Pregnant women are excluded, as well as those with certain blood counts or who need intense treatment.Check my eligibility

What is being tested?

The trial is testing the combination of venetoclax with CLAG-M chemotherapy regimen for treating specific types of leukemia. Venetoclax targets proteins that cancer cells need to survive while CLAG-M includes various drugs that kill or stop cancer cells from growing.See study design

What are the potential side effects?

Potential side effects include risks associated with venetoclax such as nausea, diarrhea, low blood cell counts leading to increased infection risk; and typical chemotherapy side effects like hair loss, fatigue, mouth sores, and potential damage to heart muscle.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.

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I can perform all my self-care but may not be able to do heavy physical work.

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My risk of dying from treatment is low.

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I have leukemia with a high-risk profile or I need further treatment after my first one didn't work.

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I am 18 years old or older.

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I have been diagnosed with a specific type of leukemia or high-grade myeloid neoplasm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year 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 adverse events

Maximum tolerated dose of venetoclax in combination with CLAG-M

Secondary outcome measures

1-year survival rate

Complete remission rate

Rate of allogeneic hematopoietic cell transplant

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Neutrophil count decreased

11%

Blood creatinine increased

11%

Hypokalaemia

11%

Dermatitis

11%

Pneumonia pseudomonal

11%

Rhinovirus infection

11%

White blood cell count decreased

11%

Pneumonia

11%

Abdominal pain

11%

Anaemia

11%

Sepsis

11%

Gastroenteritis

11%

SARS-CoV-2 test positive

11%

Electrocardiogram QT prolonged

11%

Febrile neutropenia

11%

COVID-19

11%

Supraventricular tachycardia

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CLAG-M, venetoclax)Experimental Treatment5 Interventions

Patients will receive induction with granulocyte colony-stimulating factor on days 0-5 (if peripheral white blood cell count is less than 20,000/uL), cladribine on days 1-5, cytarabine on 1-5, and mitoxantrone on days 1-3. Patients also receive venetoclax orally (PO) on days 1-14. Treatment repeats every 28-35 days for up to 2 induction cycles including mitoxantrone, and up to 4 consolidation cycles without mitoxantrone in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytarabine

2016

Completed Phase 3

~3310

Recombinant Granulocyte Colony-Stimulating Factor

2018

Completed Phase 2

~70

Cladribine

2014

Completed Phase 4

~4390

Mitoxantrone

2008

Completed Phase 3

~1510

Venetoclax

2019

Completed Phase 3

~1990

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,650 Total Patients Enrolled

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,375 Total Patients Enrolled

Mary-Beth M. PercivalPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Frequently Asked Questions

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

How many participants are included in this research project?

"Yes, the data posted on clinicaltrials.gov confirms that this particular medical trial is looking to enrol 20 participants at a single place of care. This research study was initially published on February 4th 2022 and has undergone revisions as recent as October 18th 2022."

Answered by AI

Is this experiment open to new participants?

"Affirmative. Per the information listed on clinicaltrials.gov, this research project is presently recruiting participants; it was initially posted on February 4th 2022 and last amended October 18th 2022. The trial requires 20 volunteers to be recruited from 1 medical centre."

Answered by AI

Are there any other investigations concerning Venetoclax that have been conducted?

"At present, there are 576 clinical trials assessing the efficacy of Venetoclax with 116 in their last phase. The majority of these studies take place within Toronto, however 19455 locations around the world have initiated research into this drug."

Answered by AI

Has the FDA sanctioned Venetoclax for therapeutic use?

"The safety of Venetoclax has been rated at a 1 on our scale, as this is an early stage trial and there's limited data supporting its efficacy."

Answered by AI

What are the chief indications for Venetoclax?

"Venetoclax is often prescribed to patients undergoing hemopoietic stem cell transplantation, but can also be of use in a variety of other situations, including bone marrow transfer, imaging diagnostics and infections."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

2022. "Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04797767.

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