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DNA Methyltransferase Inhibitor

Triple Drug Combo for Myeloid Leukemia

Phase 1

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and while on study treatment for up 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity (DLT)

Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Median Progression-Free Survival (PFS)

Objective Response Rate (ORR)

Overall Survival (OS)

Other study objectives

Navitoclax Target Dose Rate

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Navitoclax

2012

Completed Phase 2

~120

Venetoclax

2019

Completed Phase 3

~2240