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Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL

NCT03349281 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-10-20

No results posted yet for this study

Summary

The investigators postulate that Pevonedistat will be effective in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) when combined with a standard backbone ALL chemotherapy regimen.

Conditions

  • Refractory Acute Lymphoblastic Leukemia
  • Relapsed Acute Lymphoblastic Leukemia

Interventions

DRUG

Pevonedistat

Administered each cycle on days 1, 3 and 5.

DRUG

Vincristine

Administered each cycle on days 2, 9, 16 and 23.

DRUG

Dexamethasone

Taken orally each cycle on days 2 through 15.

DRUG

PEG-asparaginase

Administered via intramuscular injection (IM) each cycle on days 9 and 23.

DRUG

Doxorubicin

Administered via IV each cycle on day 2.

DRUG

Cytarabine

Administered to all subjects via IT injection on day 1; and on days 9, 16, and 23 to CNS positive subjects.

DRUG

Methotrexate

Administered via IT injection to CNS negative subjects on day 16; and to CNS positive subjects on days 9, 16 and 23.

DRUG

Hydrocortisone

Administered via IT injection to CNS positive subjects on days 9, 16, and 23.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Julio Barredo, MD

    lead OTHER

Principal Investigators

  • Julio Barredo, MD · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2021-08-11
Completion
2022-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03349281 on ClinicalTrials.gov