Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Conditions

• Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

29 Days - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Fludarabine — DRUG
  Intravenous (IV) infusion
• Cytarabine — DRUG
  Intravenous (IV) infusion
• Gemtuzumab Ozogamicin — DRUG
  Intravenous (IV) infusion
• Azacitidine — DRUG
  Intravenous (IV) infusion or subcutaneous injection
• Venetoclax — DRUG
  Orally via tablet or powder suspension

Study Details

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Key Dates

Start date

Oct 1, 2022

Status verified

May 2026

Primary completion

Feb 28, 2027

Completion

Apr 30, 2031

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: Control Arm without Venetoclax
  During Cycle 1 (42-day-cycles), participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. Gemtuzumab 3 mg/m\^2 will be given on Day 6 (only for participants with CD33 expression on leukemia blasts). During Cycle 2 participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. After Cycle 2 participants are assessed for HSCT or azacitidine maintenance therapy.
• Experimental: Arm B: Experimental Arm with Venetoclax
  During Cycle 1 (42-day-cycles), participants will receive 300 mg adult dose equivalent of venetoclax once on Day 1 followed by 600 mg adult dose equivalent of venetoclax on Days 2-21. Participants will also receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 8-12. Gemtuzumab 3 mg/m\^2 will be given on Day 13 (only for participants with CD33 expression on leukemia blasts). During Cycle 2, participants will receive 600 mg adult dose equivalent of venetoclax on Days 1-21. Participants will receive 30 mg/m\^2 of fludarabine followed by 2 g/m\^2 of cytarabine on Days 1-5. After Cycle 2 participants are assessed for HSCT or azacitidine maintenance therapy in combination with venetoclax.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 5 years ]

Central Contacts

• Gwen Nichols, MD
  914-821-8217
  [email protected]
• Michel Zwaan
  +31 88 972 5206
  [email protected]

Locations (45)

Find similar trials in Phoenix, AZ

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