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Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL

NCT03962465 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-08-22

No results posted yet for this study

Summary

In the proposed study, escalating doses of inotuzumab ozogamicin will be added to a standard pediatric inspired re-induction regimen and administered to patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Two re-induction regimens will be tested (one without pegaspargase and one including pegaspargase) and participants will be followed for disease status, allogeneic hematopoietic cell transplant (allo HCT), veno-occlusive disease following allo HCT, and overall survival.

Conditions

Interventions

DRUG

Inotuzumab ozogamicin

By IV, given on days 12 and 19 Inotuzumab ozogamicin is approved as a single-agent in this population (patients with B-ALL) but adding it to these drug combinations has not been tested in humans

DRUG

Prednisone Pill

Taken daily days 1-28 by mouth

DRUG

Daunorubicin

By IV, given on days 1, 8, 15, and 22

DRUG

Vincristine

By IV, given on days 1, 8, 15, and 22

DRUG

Cytarabine

Intrathecal, administered on day 1 only

DRUG

Methotrexate

Intrathecal, administered on days 8 and 29

DRUG

Pegaspargase

By IV, given on day 4

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Vanderbilt University

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • University of Virginia

    lead OTHER

Principal Investigators

  • Michael Douvas, MD · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2023-07-15
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03962465 on ClinicalTrials.gov