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DNA Methyltransferase Inhibitor
Triple Drug Combo for Myeloid Leukemia
Phase 1
Recruiting
Led By Jacqueline S Garcia, MD
Research Sponsored by Jacqueline Garcia, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up while on study treatment for up 1 year
Awards & highlights
Study Summary
This trial is testing the safety of a new three drug combination to treat advanced myeloid malignancies.
Who is the study for?
Adults diagnosed with advanced myeloid malignancies such as Myeloid Leukemia or Myelodysplastic Syndrome, who have not responded to certain previous treatments, can join. They must be in good general health with proper liver and kidney function, able to swallow pills, and willing to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing the safety of a new combination treatment for myeloid cancers using three drugs: Navitoclax, Venetoclax, and Decitabine. The goal is to see how well patients tolerate this regimen and what effects it has on their disease.See study design
What are the potential side effects?
Potential side effects from these medications may include nausea, fatigue, bleeding problems due to low platelet counts (thrombocytopenia), liver issues indicated by elevated enzymes in blood tests, infections due to weakened immune system response (neutropenia), and possibly other organ-related inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ while on study treatment for up 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~while on study treatment for up 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity (DLT)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Median Progression-Free Survival (PFS)
Objective Response Rate (ORR)
Overall Survival (OS)
Other outcome measures
Navitoclax Target Dose Rate
Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Dermatitis
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Blood creatinine increased
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%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
5Treatment groups
Experimental Treatment
Group I: Recommended Phase 2 Dose Level: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]Experimental Treatment3 Interventions
RP2D [AML and Non-AML]
Decitabine [intravenously (IV) preferred] To be determined based on dose escalation design.
Venetoclax [orally] To be determined based on dose escalation design.
Navitoclax [orally] To be determined based on dose escalation design.
Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Group II: Dose Level 2: Venetoclax + Decitabine + Navitoclax [AML]Experimental Treatment3 Interventions
Dose Level 2 [AML]
Decitabine [intravenously (IV) preferred] Cycle 1+: dosing on days 1-5
Venetoclax [orally] Cycle 1: ramp-up on day 1-2, days 3-21 continued dosing in absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing on days 1-21
Navitoclax [orally] Cycle 1: dosing on days 3-14 Cycle 2+: dosing on days 1-14
Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Group III: Dose Level 1: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]Experimental Treatment3 Interventions
Dose Level 1 [AML and Non-AML]
Decitabine [intravenously (IV) preferred] Cycle 1+: dosing on days 1-5
Venetoclax [orally] Cycle 1: ramp-up starting on day 1-2 then days 3-14 continued dosing in absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing days 1-14
Navitoclax [orally] Cycle 1: Dosing days 3-14 Cycle 2+: dosing on days 1-14
Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Group IV: Dose Level 0: Decitabine + Venetoclax + Navitoclax [AML and Non-AML]Experimental Treatment3 Interventions
Dose Level 0 [AML and Non-AML]
Decitabine [intravenously (IV) preferred]
Venetoclax Cycle 1: ramp-up days 1-2 and days 3-14 absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing days 1-14
Navitoclax Cycle 1: dosing days 3-14; Cycle 2+: dosing on days 1-14
Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Group V: Dose Level -1: Venetoclax + Decitabine + Navitoclax [Non-AML]Experimental Treatment3 Interventions
Dose Level -1 [Non-AML]
Decitabine [intravenously (IV) preferred] Cycle 1+:dosing [intravenously (IV) preferred] on days 1-3
Venetoclax [orally] Cycle 1: ramp-up of starting day 1-2 then days 3-7 continued dosing in absence of strong/moderate CYP3A inhibitor and reduced doses dependent on presence of moderate or strong CYP3A inhibitor Cycle 2+: dosing on days 1-7
Navitoclax [orally] Cycle 1: Dosing days 3-14 Cycle 2+: continued dosing on days 1-14
Cycle length=28 days Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Decitabine
2004
Completed Phase 3
~1680
Navitoclax
2012
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Jacqueline Garcia, MDLead Sponsor
2 Previous Clinical Trials
116 Total Patients Enrolled
AbbVieIndustry Sponsor
958 Previous Clinical Trials
502,354 Total Patients Enrolled
Jacqueline S Garcia, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My leukemia has spread to my brain or spinal cord.I haven't had leukemia treatment in the last 14 days, except for hydroxyurea.I have never been treated with navitoclax or any BCL-XL inhibitors.I have another cancer that doesn't need treatment right now.I am willing and able to undergo intensive chemotherapy.I have HIV that is not well-controlled and I am on medication that is not allowed in the trial.I do not have any uncontrolled health conditions or recent serious infections.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 0: Decitabine + Venetoclax + Navitoclax [AML and Non-AML]
- Group 2: Dose Level 1: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]
- Group 3: Dose Level 2: Venetoclax + Decitabine + Navitoclax [AML]
- Group 4: Dose Level -1: Venetoclax + Decitabine + Navitoclax [Non-AML]
- Group 5: Recommended Phase 2 Dose Level: Venetoclax + Decitabine + Navitoclax [AML and Non-AML]
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are engaged in this clinical experiment?
"Correct. According to information from clinicaltrials.gov, this research project is presently enrolling participants and has been since July 18th 2022. The trial seeks a total of 36 patients across 3 medical facilities."
Answered by AI
Has Venetoclax obtained clearance from the Federal Drug Administration?
"Venetoclax's safety is estimated to be a score of 1 due to the lack of clinical data validating its efficacy and safety. This evaluation was made by our team at Power given that this trial is in Phase 1."
Answered by AI
Are there any available places for participants in this research?
"Per the information listed on clinicaltrials.gov, enrollment for this trial is still open to new participants. The original posting date was July 18th 2022 and it has been recently revised on July 21st of the same year."
Answered by AI
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