Trial Search Results

Study of Venetoclax in Combination With Chemotherapy in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Leukemia of Ambiguous Lineage

The purpose of this study is to test the safety of venetoclax and to find the highest dose of venetoclax that can be given safely when it is combined with one or two chemotherapy drugs (cytarabine or cytarabine and idarubicin). This study tests different doses of venetoclax to see which dose is safer in children with leukemia.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

St. Jude Children's Research Hospital

Collaborator: Gateway for Cancer Research

Stanford Investigator(s):

Intervention(s):

  • Drug: Venetoclax
  • Drug: Cytarabine
  • Drug: Idarubicin
  • Drug: Intrathecal Triple Therapy

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Participants must have a diagnosis of AML or acute leukemia of ambiguous lineage
   (acute undifferentiated leukemia or mixed phenotype a cute leukemia) and meet the
   criteria below:

      - Refractory leukemia, defined as persistent leukemia after at least two courses of
      induction chemotherapy, OR

      - Early relapsed leukemia, defined as the re-appearance of leukemia after the
      achievement of remission and within one year of diagnosis, OR

      - Relapsed leukemia that is refractory to at least one course of salvage therapy
      (i.e., therapy given after the relapse has occurred), OR

      - Second or greater relapse

      - Patients with late relapses, defined as the re-appearance of leukemia after the
      achievement of remission and greater than one year from diagnosis, may be
      enrolled in the dose expansion portion of the study only.

      - Patients in all categories above must have ≥ 5% blasts in the bone marrow as
      assessed by morphology or > 1 blasts in the bone marrow as assessed by flow
      cytometry. However, if an adequate bone marrow sample cannot be obtained,
      patients may be enrolled if there is unequivocal evidence of leukemia with ≥ 5%
      blasts in the peripheral blood. In addition, patients in all categories must not
      be eligible to undergo curative therapy, such as immediate SCT, because of
      disease burden, time needed to identify a stem cell donor, or other reasons.

   - Adequate organ function defined as the following:

      - Direct bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)

      - AST (SGOT) and ALT (SGPT) ≤ 4 x ULN

      - Normal creatinine for age or a calculated creatinine clearance ≥ 60 mL/min/1.73
      m2

      - Left ventricular ejection fraction ≥ 40% or shortening fraction ≥ 25%

   - St. Jude patients must be between 2 years and ≤ 21 years of age, on therapy (active
   patient), or within 3 years of completion of therapy. Patients treated at
   collaborating sites must be ≤ 24 years old.

   - Performance status: Lansky ≥ 50 for patients who are ≤ 16 years old and Karnofsky ≥
   50% for patients who are > 16 years old.

   - Patients must have fully recovered from the acute effects of all prior therapy and
   cannot have evidence of graft-versus-host disease (GVHD)

Exclusion Criteria:

   - Must not be pregnant or breastfeeding. Male or female of reproductive potential must
   agree to use effective contraception for the duration of study participation.

   - Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic
   leukemia, or bone marrow failure syndromes are not eligible.

   - Uncontrolled infection. Infections controlled on concurrent anti-microbial agents are
   acceptable, and anti-microbial prophylaxis per institutional guidelines are
   acceptable.

   - Impairment of GI function or GI disease that may significantly alter the absorption of
   venetoclax.

Ages Eligible for Study

2 Years - 20 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christopher Le
650-725-4318
Recruiting