Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03962465 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of B-cell Acute Lymphoblastic Leukemia, sponsored by University of Virginia.

Active
Registry status
Phase 1
Development phase
36
Enrollment target
4
Study locations

NCT03962465 is a Phase 1 study of B-cell Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 36 participants, below the 87-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (59% lower). The trial reports 4 study locations across 3 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03962465, a Phase 1 study of B-cell Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by University of Virginia.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
4
Study locations

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 Studied

B-cell Acute Lymphoblastic Leukemia

Interventions

  • DRUG Vincristine
  • DRUG Cytarabine
  • DRUG Daunorubicin
  • DRUG Inotuzumab ozogamicin
  • DRUG Prednisone Pill

Study Locations (4)

Virginia

  • University of Virginia - Charlottesville
  • VCU Massey Cancer Center - Richmond

Tennessee

  • Vanderbilt-Ingram Cancer Center - Nashville

Wisconsin

  • University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2022-07-22
Est. Completion 2026-07
Phase Phase 1

Sponsor

University of Virginia

449 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03962465

The ClinicalTrials.gov registry entry for NCT03962465 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 87-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (59% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Vincristine is the first listed.

NCT03962465 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Virginia, Tennessee, Wisconsin.

Frequently Asked Questions

What is clinical trial NCT03962465 about?

NCT03962465 is a clinical study titled "Phase I Study of Inotuzumab With Augmented BFM Re-Induction for Patients With Relapsed/Refractory B-cell ALL". 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 pegaspargas...

What is the current status of trial NCT03962465?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-07-22. Estimated completion is 2026-07.

What conditions does trial NCT03962465 study?

This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT03962465?

The interventions under investigation include: Vincristine (DRUG), Cytarabine (DRUG), Daunorubicin (DRUG), Inotuzumab ozogamicin (DRUG), Prednisone Pill (DRUG).

Who is sponsoring clinical trial NCT03962465?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03962465 being conducted?

This trial has 4 study locations across Tennessee, Virginia, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for B-cell Acute Lymphoblastic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

B-cell Acute Lymphoblastic Leukemia

All registered trials for this condition

Tennessee

All trials with a study site in Tennessee

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.