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Anti-metabolites

Low Dose Decitabine + Venetoclax for Blood Cancer

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

Must not have

Prior Treatment with azacitidine, decitabine or venetoclax

APL (acute promyelocytic leukemia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with azacitidine, decitabine, or venetoclax before.

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I have been diagnosed with acute promyelocytic leukemia.

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I am not willing to use two forms of birth control.

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I am allergic to decitabine or venetoclax.

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My HIV infection is not under control.

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

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

Primary study objectives

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

Secondary study objectives

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

Event-free survival (EFS)

Infection rate requiring hospitalization

+3 more

Side effects data

From 2022 Phase 3 trial • 727 Patients • NCT02085408

94%

White blood cell decreased

93%

Platelet count decreased

89%

Neutrophil count decreased

89%

Anemia

26%

Aspartate aminotransferase increased

22%

Alanine aminotransferase increased

19%

Creatinine increased

17%

Blood bilirubin increased

13%

Alkaline phosphatase increased

11%

Hypomagnesemia

Febrile neutropenia

Lymphocyte count decreased

Lung infection

Fatigue

Hyperglycemia

Urinary tract infection

Diarrhea

Investigations - Other, specify

Colitis

Hypoxia

Dyspnea

Pneumonitis

Infections and infestations - Other

Hyponatremia

Pharyngitis

Hypokalemia

Generalized muscle weakness

Skin infection

Eye disorders - Other, specify

Leukocytosis

Thromboembolic event

100%

80%

60%

40%

20%

Study treatment Arm

Arm F (Maintenance: Decitabine)

Arm B (Induction: Clofarabine)

Arm A (Induction: Daunorubicin + Cytarabine)

Arm C (Consolidation: Cytarabine)

Arm D (Consolidation: Clofarabine)

Arm E (Maintenance: Observation)

Arm G (Transplant)

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

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 / 10Eligibility criteria met