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

Conditions

• Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

N/A - 365 Days

Healthy Volunteers

Not accepted

Interventions

• ITMHA — DRUG
  Given intrathecally (IT).
• Dexamethasone — DRUG
  Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
• Mitoxantrone — DRUG
  Given IV.
• Pegaspargase — DRUG
  Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used.
• Asparaginase Erwinia Chrysanthemi — DRUG
  Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM).
• Bortezomib — DRUG
  Given IV.
• Vorinostat — DRUG
  Taken PO or NG.
• Cyclophosphamide — DRUG
  Given IV.
• Mercaptopurine — DRUG
  Given PO or NG.
• Methotrexate — DRUG
  Given IV, IM or PO.
• Leucovorin Calcium — DRUG
  Leucovorin rescue PO or IV.
• Cytarabine — DRUG
  Given IV.
• Etoposide — DRUG
  Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given.
• Vincristine — DRUG
  Given IV.

Study Details

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.

Key Dates

Start date

Jan 29, 2016

Status verified

Dec 2025

Primary completion

May 10, 2022

Completion

Oct 31, 2031

Study Design

Enrollment

50 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  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.

Primary Outcome Measure

Percentage of Treatment-related Mortality (TRM) [ Time Frame: At the end of reinduction (up to 5 months after start of therapy) ]

Locations (9)

Find similar trials in Los Angeles, CA

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