RecruitingPhase 2

Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 365 Days
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 3 years
  • Procedures mentioned: Blood draws, MRI scans, CT scans, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of MARMA in the absence of disease progression or unacceptable toxicity."
  • "Cycles repeat every 12 weeks (84 days) for up to 2 years from the start of interim maintenance 1 in the absence of disease progression or unacceptable toxicity."
  • "All patients undergo bone marrow aspiration, collection of blood samples and echocardiography (ECHO) or multigated acquisition scan (MUGA) throughout the trial."
  • "Patients may undergo computed tomography (CT), magnetic resonance imaging (MRI), fludeoxyglucose-positron emission tomography (FDG-PET), and/or lumbar puncture if clinically indicated."
  • "After completion of study treatment, patients are followed up for up to 3 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests adding venetoclax, blinatumomab, or both to usual chemotherapy for infants with newly diagnosed acute lymphoblastic leukemia (ALL), a blood cancer. It includes infants with or without a change in the KMT2A gene. Researchers will check whether these added drugs are safe and work better than chemotherapy alone.

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must join the APEC14B1 study and agree to its eligibility screening before treatment and joining this study.
  • Must be 365 days old or younger when diagnosed.
  • Time in the womb plus time since birth must total more than 36 weeks when joining.
  • Must have newly diagnosed B-cell ALL or acute leukemia with an unclear or mixed cell type. For unclear or mixed types, at least half of the leukemia cells must be B-cell type.
  • Leukemia cells must have a marker called CD19.
  • A parent, legal guardian, or patient, as appropriate, must sign a form agreeing to join.
  • All hospital and federal rules for studies in people must be met.

Who can't join

  • Infants with Down syndrome cannot join.
  • Infants whose B-cell ALL developed after chemotherapy for an earlier cancer cannot join.
  • Past cell-killing chemotherapy for this leukemia or any earlier cancer is not allowed, except for the limited treatments below.
  • Prednisone, prednisolone, or methylprednisolone is allowed for no more than 3 days in the week before joining. Inhaled steroids and steroids used on the skin do not count. Steroids taken more than 28 days before joining do not affect eligibility.
  • Dexamethasone in the 28 days before study treatment is not allowed, except one dose during or within 6 hours before or after sedation to prevent or treat airway swelling.
  • One dose of cytarabine or methotrexate into the fluid around the spinal cord in the week before joining is allowed.
  • Hydroxyurea for no more than 3 days in the week before joining is allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321 * Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \> 36 weeks gestational age (cumulative prenatal and postnatal age must be \> 36 weeks) at the time of enrollment * Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \[WHO\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage * Diagnostic immunophenotype: Leukemia cells must express CD19 Exclusion Criteria: * Patients with Down Syndrome * Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy * Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of: * Steroid pretreatment: * PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility * Inhaled and topical steroids are not considered pretreatment * Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \> 28 days before enrollment does not affect eligibility * Intrathecal cytarabine or methotrexate: * An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility * Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status * Hydroxyurea: * Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met

Study sites (115)

AK

AL

AR

AZ

  • Banner Children's at Desert · Mesa, AZ 85202Site Public Contact · Study contact · 480-412-3100Joseph C. Torkildson · Principal investigatorMore trials in Mesa

CA

CO

CT

DC

DE

FL

GA

HI

  • Kapiolani Medical Center for Women and Children · Honolulu, HI 96826Site Public Contact · Study contact · 808-983-6090Wade T. Kyono · Principal investigatorMore trials in Honolulu

IA

ID

IL

IN

KY

LA

MA

MD

ME

MI

MN

MO

MS

  • University of Mississippi Medical Center · Jackson, MS 39216Site Public Contact · Study contact · 601-815-6700Amanda Strobel · Principal investigatorMore trials in Jackson

NC

ND

NE

  • Children's Hospital and Medical Center of Omaha · Omaha, NE 68114Site Public Contact · Study contact · 402-955-3949Jill C. Beck · Principal investigatorMore trials in Omaha

NH

NJ

NV

NY

OH

OK

PA

RI

SC

SD

TN

TX

VA

WA

WI