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NCT01925131 · ClinicalTrials.gov registry record · Phase 1
S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia
A Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Burkitt Lymphoma, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 5
- Study locations
NCT01925131 is a Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Burkitt Lymphoma that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 50 participants, below the 64-participant average among 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials with a reported enrollment target (22% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT01925131, a Phase 1 study of Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Burkitt Lymphoma, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG prednisone
- DRUG cyclophosphamide
- DRUG vincristine sulfate
- BIOLOGICAL inotuzumab ozogamicin
Study Locations (5)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Stanford Cancer Institute Palo Alto - Palo Alto
New York
- University of Rochester - Rochester
Ohio
- Cleveland Clinic Foundation - Cleveland
Texas
- Ben Taub General Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-06-13 |
| Est. Completion | 2023-01-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01925131
The ClinicalTrials.gov registry entry for NCT01925131 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 64-participant average among 8 other Recurrent Adult Acute Lymphoblastic Leukemia trials with a reported enrollment target (22% lower). The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Recurrent Adult Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT01925131 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT01925131 about?
NCT01925131 is a clinical study titled "S1312, Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Leukemia". This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentia...
What is the current status of trial NCT01925131?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2014-06-13. Estimated completion is 2023-01-01.
What conditions does trial NCT01925131 study?
This clinical trial studies the following conditions: Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Burkitt Lymphoma, B-cell Adult Acute Lymphoblastic Leukemia, Acute Leukemias of Ambiguous Lineage, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT01925131?
The interventions under investigation include: laboratory biomarker analysis (OTHER), prednisone (DRUG), cyclophosphamide (DRUG), vincristine sulfate (DRUG), inotuzumab ozogamicin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01925131?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01925131 being conducted?
This trial has 5 study locations across California, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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