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Anti-metabolites

Low Dose Decitabine + Venetoclax for Blood Cancer

Q: What potential risks are associated with Decitabine treatment?

Our team assesses that Decitabine possesses an adequate degree of safety, as evidenced by its rating of 2. This implies there is some research indicating the drug's security but no studies demonstrating its efficacy in treating a condition.

Q: Are there any vacancies for this clinical research initiative?

The clinicaltrials.gov database confirms that this trial, which was first advertised on March 23rd 2022 is actively recruiting for participants. This information was last updated on July 22nd the same year.

Q: What is the participant capacity for this experiment?

Indeed, the data hosted on clinicaltrials.gov shows that this medical study is presently enrolling individuals. This trial was initially posted on March 23rd 2022 and has since been modified as recently as July 22nd 2022 - 33 patients are sought from a single site.

Phase 2

Recruiting

Led By Mendel Goldfinger, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

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

Must have

Patients must have adequate end organ function defined as: AST (aspartate aminotransferase) and ALT (alanine transaminase) < 4× the upper limit of normal (ULN), Bilirubin ≤ 2× the ULN (upper limit of normal). If elevated bilirubin is due to impaired conjugation (e.g Gilbert's disease or concomitant medication) or disease related hemolysis, then direct bilirubin ≤ 1.5× the ULN, Renal function with a creatinine clearance ≥30 mL/min or on dialysis is allowed, Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures

Indication for therapy with potential sensitivity to HMA (hypomethylating agents) therapy, defined as prior published evidence of response to HMA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing if a lower dose of Decitabine and venetoclax can kill cancer cells in people with myeloid malignancies while causing less damage to normal cells.

Who is the study for?

Adults diagnosed with Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or MDS/MPN who may benefit from hypomethylating agents. Participants must be over 18, have an ECOG status of ≥3, and adequate liver function. Pregnant or breastfeeding individuals, those with certain heart conditions, uncontrolled illnesses, active infections not well-managed by medication, or known allergies to the drugs are excluded.Check my eligibility

What is being tested?

The trial is testing a combination of two drugs: Venetoclax and Decitabine at low doses on a weekly schedule for treating bone marrow cancers like AML and MDS. The goal is to see if this regimen can reduce side effects while effectively targeting malignant cells in the bone marrow.See study design

What are the potential side effects?

Potential side effects include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems. Liver function abnormalities might occur as well as potential drug-specific reactions which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

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

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My condition has previously responded well to HMA therapy.

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I need help with my daily activities due to my health condition.

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I am 18 years old or older.

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I have been diagnosed with MDS, AML, or MDS/MPN confirmed by a specialist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

1. Percentage of participants who are able to continue on treatment without dose interruptions or delays

Secondary outcome measures

Complete remission or complete remission with partial hematologic recovery rate (CR+CRh)

Event-free survival (EFS)

Global health status/quality of life (GHS/QoL) [ Time Frame: Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter]

+4 more

Side effects data

From 2022 Phase 2 trial • 14 Patients • NCT04055844

57%

Febrile neutropenia

57%

Neutrophil count decreased

21%

Infections and infestations - Other, specify

21%

Lung infection

21%

Bacteremia

21%

Sepsis

14%

Aspartate aminotransferase increased

14%

Alanine aminotransferase increased

14%

Infections and infestations - Other,

Mucositis oral

White blood cell decreased

Syncope

Upper gastrointestinal

Sinusitis

Hyperglycemia

Hypertension

Encephalopathy

Hepatobiliary disorders

Blood and lymphatic system

General disorders and administration

INR increased

Typhlitis

Upper gastrointestinal hemorrhage

Hepatic failure

Injury, poisoning and procedural

Blood and lymphatic system disorders - Other, specify

Fatigue

Intracranial hemorrhage

Gastrointestinal disorders - Other,

Disease progression

Fever

Skin and subcutaneous tissue disorders - Other, specify

Neoplasms benign, malignant and

Alanine aminotransferase

Tooth infection

Gastrointestinal disorders - Other, specify

Pericardial effusion

General disorders and administration site conditions - Other, specify

Hepatic infection

100%

80%

60%

40%

20%

Study treatment Arm

Decitabine + Ruxolitinib + DLI

Trial Design

1Treatment groups

Experimental Treatment

Group I: Decitabine/Venetoclax (Single Arm)Experimental Treatment2 Interventions

Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitaboine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

FDA approved

Venetoclax

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

441 Previous Clinical Trials

582,111 Total Patients Enrolled

Mendel Goldfinger, MDPrincipal InvestigatorMontefiore Medical Center

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05184842 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Decitabine/Venetoclax (Single Arm)

Acute Myeloid Leukemia Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT05184842 — Phase 2

Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05184842 — Phase 2

Frequently Asked Questions

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

What potential risks are associated with Decitabine treatment?

"Our team assesses that Decitabine possesses an adequate degree of safety, as evidenced by its rating of 2. This implies there is some research indicating the drug's security but no studies demonstrating its efficacy in treating a condition."

Answered by AI

Are there any vacancies for this clinical research initiative?

"The clinicaltrials.gov database confirms that this trial, which was first advertised on March 23rd 2022 is actively recruiting for participants. This information was last updated on July 22nd the same year."

Answered by AI

What is the participant capacity for this experiment?

"Indeed, the data hosted on clinicaltrials.gov shows that this medical study is presently enrolling individuals. This trial was initially posted on March 23rd 2022 and has since been modified as recently as July 22nd 2022 - 33 patients are sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML

2022. "Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05184842.