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NCT03739814 · ClinicalTrials.gov registry record · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
A Phase 2 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT03739814 is a Phase 2 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 64 participants, below the 146-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT03739814, a Phase 2 study of Recurrent B Acute Lymphoblastic Leukemia and Refractory B Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- BIOLOGICAL Blinatumomab
- BIOLOGICAL Inotuzumab Ozogamicin
Study Locations (20)
California
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Community Cancer Institute - Clovis
- University Oncology Associates - Clovis
- City of Hope Comprehensive Cancer Center - Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Institute Palo Alto - Palo Alto
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Kingman Regional Medical Center - Kingman
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-05-08 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03739814
The ClinicalTrials.gov registry entry for NCT03739814 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 146-participant average among 12 other Recurrent B Acute Lymphoblastic Leukemia trials with a reported enrollment target (56% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Recurrent B Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03739814 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alaska, Alabama.
Frequently Asked Questions
What is clinical trial NCT03739814 about?
NCT03739814 is a clinical study titled "Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia". This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment...
What is the current status of trial NCT03739814?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2019-05-08. Estimated completion is 2027-02-01.
What conditions does trial NCT03739814 study?
This clinical trial studies the following conditions: Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative.
What interventions are being tested in trial NCT03739814?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Blinatumomab (BIOLOGICAL), Inotuzumab Ozogamicin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03739814?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03739814 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.
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