Health TrialsbyHealthPanel

Venetoclax to Augment Epigenetic Modification and Chemotherapy

ConditionsAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia Refractory
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-25
SponsorMedical College of Wisconsin

About this trial

The investigator is testing the addition of venetoclax to 5-azacitidine and vorinostat followed by standard chemotherapy to enhance treatment response in AML patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis

Patients with AML must have measurable disease (≥M1 marrow) in the bone marrow.

1st or greater relapse, OR

Failed to go into remission after 1st or greater relapse, OR

Disqualifiers

Patients will be excluded if they have a systemic fungal, bacterial, viral, or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. The patient needs to be off pressors and have negative blood cultures for 48 hours.

Patients will be excluded if they have had any positive fungal culture within 30 days prior to enrollment or evidence of disseminated fungal disease.

Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.

Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder, or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Venetoclax

    Drug

    Dose Level 0: Day 1 60 mg/m2 PO x1, Days 2-14 120 mg/m2/dose PO once daily (Max: 200 mg/day) Dose level 1: Day 1 120 mg/m2 PO x1, Days 2-14 240 mg/m2/dose PO once daily (Max: 400 mg/day) Dose level 2: Day 1 180 mg/m2 PO x1, Days 2-14 360 mg/m2/dose PO once daily (Max: 600 mg/day)

  • Azacitadine

    Drug

    75 mg/m2/dose IV once daily over 15 minutes

  • Vorinostat

    Drug

    1 year to 17.99 years old: 180 mg/m2/dose PO once daily ≥18 years old 200 mg PO BID. Doses should be separated by 12 hr (±4 hr)

  • Cytarabine

    Drug

    2000 mg/m2/dose IV once daily over 3 hours IT Cytarabine: 1. \- 1.99 years old: 30 mg 2. \- 2.99 years old: 50 mg * 3 years old: 70 mg

  • Fludarabine

    Drug

    30 mg/m2/dose IV once daily over 30 minutes

  • Filgrastim

    Drug

    5 microgram/kg/dose subcutaneous (or IV over 15-30 min) once daily

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: AML without Down SyndromeOther 6 interventions
Group B: AML with Down SyndromeOther 6 interventions

Trial outcomes

Primary outcomes

1

Venetoclax Dose-Limiting Toxicity

The primary endpoint, for dose escalation of venetoclax, is the occurrence of a dose-limiting toxicity (DLT) observed during the first course of therapy.

Time frame
42 months

Secondary outcomes

1

Response Rates

Response rates as measured by morphologic response (CR)

Time frame
42 months
2

Response Rates

Response rates as measured by morphologic response (PD)

Time frame
42 months
3

Response Rates

Response rates as measured by morphologic response (SD)

Time frame
42 months
4

Response Rates

Response rates as measured by morphologic response (CRi)

Time frame
42 months

Other outcomes

Sponsors and contacts

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

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
Apply now