Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

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Brief Title

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Official Title

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I

Brief Summary

      The purpose of this study is to test the good and bad effects of the study drugs bortezomib
      and vorinostat when they are given in combination with chemotherapy commonly used to treat
      acute lymphoblastic leukemia (ALL) in infants. For example, adding these drugs could decrease
      the number of leukemia cells, but it could also cause additional side effects. Bortezomib and
      vorinostat have been approved by the US Food and Drug Administration (FDA) to treat other
      cancers in adults, but they have not been approved for treating children with leukemia. With
      this research, we plan to meet the following goals:

      PRIMARY OBJECTIVE:

        -  Determine the tolerability of incorporating bortezomib and vorinostat into an ALL
           chemotherapy backbone for newly diagnosed infants with ALL.

      SECONDARY OBJECTIVES:

        -  Estimate the event-free survival and overall survival of infants with ALL who are
           treated with bortezomib and vorinostat in combination with an ALL chemotherapy backbone.

        -  Measure minimal residual disease (MRD) positivity using both flow cytometry and PCR.

        -  Compare end of induction, end of consolidation, and end of reinduction MRD levels to
           Interfant99 (ClinicalTrials.gov registration ID number NCT00015873) participant
           outcomes.
    

Detailed Description

      Treatment will consist of 4 main phases: Remission Induction, Consolidation, Reinduction, and
      Maintenance. High risk patients will receive a reintensification phase prior to transplant in
      first remission.

      REMISSION INDUCTION: Chemotherapy will be given in an attempt to induce the participant's
      leukemia into remission. Drugs given are intrathecal triple drug treatment with methotrexate,
      hydrocortisone and Ara-C (ITMHA); dexamethasone; vorinostat; bortezomib; PEG-asparaginase;
      mitoxantrone; cyclophosphamide; cytarabine; and 6-mercaptopurine.

      CONSOLIDATION PHASE: After the participant's blood counts have recovered from Remission
      Induction, he/she will move to the consolidation phase. This therapy is given to kill any
      remaining leukemia cells. Drugs given are ITMHA, high-dose methotrexate, and
      6-mercaptopurine.

      RE-INDUCTION: This phase aims to improve the participant's overall response to therapy by
      again seeking to bring his/her leukemia into remission. Drugs given are ITMHA, mitoxantrone,
      peg-asparaginase, dexamethasone, bortezomib, and vorinostat.Participants that achieve MRD
      negative status following Re-Induction may proceed directly to stem cell transplant (SCT)
      (SCT not part of this study).

      RE-INTENSIFICATION: Participants that remain MRD positive following Consolidation or
      Reinduction may receive Chimeric Antigen Receptor T-Cell therapy (CART), if available (CART
      is not part of this study), or proceed to a Reintensification phase then go on to stem cell
      transplant (SCT).

      MAINTENANCE PHASE: Participants with negative MRD after consolidation will skip the
      re-intensification phase and proceed to receive maintenance therapy to keep the leukemia from
      returning. Drugs given are ITMHA, dexamethasone, vincristine, 6-mercaptopurine and
      methotrexate. Each cycle of these drugs lasts 28 days and will be repeated up to 20 times as
      long as there are no serious side effects.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Probability of treatment-related mortality (TRM) during induction or reinduction therapy

Secondary Outcome

 3-year event free survival (EFS)

Condition

Acute Lymphoblastic Leukemia

Intervention

ITMHA

Study Arms / Comparison Groups

 Treatment
Description:  Participants who meet eligibility requirements will receive remission induction, consolidation treatment, reinduction, reintensification and maintenance therapy.
Interventions: ITMHA, dexamethasone, mitoxantrone, pegaspargase or asparaginase Erwinia chrysanthemi, bortezomib, vorinostat, cyclophosphamide, mercaptopurine, methotrexate, leucovorin calcium, cytarabine, etoposide, and vincristine.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

January 29, 2016

Completion Date

October 2031

Primary Completion Date

February 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patient is ≤ 365 days of age at the time of diagnosis.

          -  Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute
             undifferentiated leukemia with ≥25% blasts in the bone marrow (M3), with or without
             extramedullary disease. Patients with T-cell ALL are eligible. Patients with bilineage
             or biphenotypic acute leukemia are eligible, provided the morphology and
             immunophenotype are predominantly lymphoid.

          -  Limited prior therapy, including hydroxyurea for 72 hours or less, systemic
             glucocorticoids for one week or less, one dose of vincristine, and one dose of
             intrathecal chemotherapy.

          -  Written informed consent following Institutional Review Board, NCI, FDA, and Office
             for Human Research Protections (OHRP) Guidelines.

        Exclusion Criteria:

          -  Patients with prior therapy, other than therapy specified in the Inclusion Criteria.

          -  Patients with mature B-cell ALL or acute myelogenous (AML).

          -  Patients with Down syndrome.

          -  Inability or unwillingness of legal guardian/representative to give written informed
             consent.
      

Gender

All

Ages

N/A - 365 Days

Accepts Healthy Volunteers

No

Contacts

Tanja A. Gruber, MD, PhD, 866-278-5833, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02553460

Organization ID

TINI

Secondary IDs

NCI-2015-01493

Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital

Collaborators

 Gateway for Cancer Research

Study Sponsor

Tanja A. Gruber, MD, PhD, Principal Investigator, St. Jude Children's Research Hospital


Verification Date

October 2019