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ACTIVE NOT RECRUITING
NCT03962465
PHASE1

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

Sponsor: University of Virginia

View on ClinicalTrials.gov

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.

Official title: Phase I Study of Inotuzumab Ozogamicin With 3 and 4 Drug Augmented Berlin-Frankfurt-Münster (BFM) Re-Induction for Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)

Key Details

Gender

All

Age Range

16 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2022-07-22

Completion Date

2026-07

Last Updated

2023-08-22

Healthy Volunteers

No

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

Locations (4)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

University of Virginia

Charlottesville, Virginia, United States

VCU Massey Cancer Center

Richmond, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States