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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: Active Phase 1 study of B-cell Acute Lymphoblastic Leukemia, sponsored by University of Virginia.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What the registry record for NCT03962465 still lists
NCT03962465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 87-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (59% lower).
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 a single indexed study location in 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.
Where NCT03962465's enrollment target sits among peer trials
36 16th of 21 higher than 5 of 21 other B-cell Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B-cell Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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