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Pilot Study of Reduced Venetoclax Exposure

ConditionAcute Myeloid Leukemia in Remission
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health

About this trial

Pilot Study of Reduced Venetoclax Exposure

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stated willingness to comply with all study procedures and availability for the duration of the study

Ability to take oral medication and be willing to adhere to the study regimen

5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)

Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)

Disqualifiers

Treatment with another investigational drug

Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.

On concomitant targeted therapy such as FLT3 inhibitor or IDH1/2 inhibitor.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azacitidine

    Drug

    Given Day 1-7 with Venetoclax Day 1-14 every 28 days until off study

  • Decitabine

    Drug

    Given Day 1-5 with Venetoclax Day 1-14 every 28 days until off

  • Venetoclax

    Drug

    Venetoclax up to 400mg a day on Day 1-14 every 28 days until off in combination with Azacitidine or Decitabine

Treatment groups

41 Participants
are divided into 2 treatment groups
Group A: Azacytadine + VenetoclaxActive comparator 2 interventions
Group B: Decitabine + VenetoclaxActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Venetoclax Tolerability Rate

Tolerability rate defined as the proportion of patients who do not experience grade 4 neutropenia (per the CTCAE v5.0) for over 7 continuous days within the first three cycles of maintenance therapy (90 days). Patient will be evaluated on Day 1 of each cycle. Laboratory studies of prior cycle will be reviewed on that day to identify if patient had \>7 continuous days of cytopenia.

Time frame
12 months

Secondary outcomes

1

Evaluation of Event-Free Survival (EFS)

EFS: Time from treatment-to-treatment discontinuation, relapse, death of any cause, or lost to follow up (Lost to follow up defined as missing scheduled appointment with no response to 3 phone calls and 1 certified letter).

Time frame
12 months
2

Time to Detriment

Time to detriment defined as time to meaningful change in the EORTC-QLQ-C30. A meaningful change is defined as a decrease by at least 10 points from their baseline evaluation The EORTC-QLQ0-C30 will be filled out by patient on Day 1 of every cycle for the first 12 cycles of maintenance therapy.

Time frame
48 months
3

Number of pRBC transfusion

Number of pRBC transfusion received while on trial therapy. Number of platelet transfusion received while on trial therapy. Number of transfusions to be described per patient year. Data collected on Day 1 of every cycle.

Time frame
48 months
4

Evaluate Number of Hospital Admissions

To be evaluated at time of trial therapy discontinuation or 12 cycles of therapy, whichever occurs first.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov
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