Decitabine for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Montefiore Medical Center, Bronx, NYAcute Myeloid Leukemia+1 MoreDecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 12 months

12 months
1. Percentage of participants who are able to continue on treatment without dose interruptions or delays
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]
Infection rate requiring hospitalization
Post baseline transfusion independence rate
Rate of Hospitalization
3 months
Complete remission or complete remission with partial hematologic recovery rate (CR+CRh)
Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Lead In Phase
19%PNEUMONIA
14%BACTERAEMIA
10%ANAEMIA
10%CELLULITIS
10%PNEUMONIA FUNGAL
5%DEHYDRATION
5%MYOCARDIAL INFARCTION
5%GASTROINTESTINAL HAEMORRHAGE
5%DIARRHOEA
5%PYREXIA
5%SEPSIS
5%URINARY TRACT INFECTION
5%FALL
5%SYNCOPE
5%HYPERTENSION
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT01303796) in the Lead In Phase ARM group. Side effects include: PNEUMONIA with 19%, BACTERAEMIA with 14%, ANAEMIA with 10%, CELLULITIS with 10%, PNEUMONIA FUNGAL with 10%.

Trial Design

1 Treatment Group

Single Arm
1 of 1

Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: Decitabine · No Placebo Group · Phase 2

Single ArmExperimental Group · 2 Interventions: Venetoclax, Decitabine · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2100
Decitabine
2004
Completed Phase 3
~1910

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
412 Previous Clinical Trials
554,788 Total Patients Enrolled
Mendel Goldfinger, MDPrincipal InvestigatorMontefiore Medical Center

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.