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NCT02981628 · ClinicalTrials.gov registry record · Phase 2
Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia
A Phase 2 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT02981628: Recruiting Phase 2 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, sponsored by Children's Oncology Group.
NCT02981628 is a Phase 2 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 80 participants, below the 145-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02981628, a Phase 2 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Children's Oncology Group.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.
Primary Outcome
The response rate will be estimated using the proportion of eligible/evaluable patients with CR/CRi response. A one-sided lower 95% Agresti-Coull confidence limit will be calculated.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Asparaginase Erwinia chrysanthemi
- DRUG Calaspargase Pegol
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2017-06-19 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT02981628 shows while recruiting
NCT02981628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 145-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (45% lower).
The record links to 4 conditions, with Recurrent B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02981628 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT02981628 about?
NCT02981628 is a clinical study titled "Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia". This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, cal...
What is the current status of trial NCT02981628?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2017-06-19. Estimated completion is 2026-12-31.
What conditions does trial NCT02981628 study?
This clinical trial studies the following conditions: Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma, Refractory B Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT02981628?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Asparaginase Erwinia chrysanthemi (DRUG), Calaspargase Pegol (DRUG).
Who is sponsoring clinical trial NCT02981628?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02981628 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent B 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 NCT02981628's enrollment target sits among peer trials
80 4th of 12 higher than 9 of 12 other Recurrent B Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent B 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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