Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
NCT04530565 · View on ClinicalTrials.gov ↗
Study Summary
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- DRUG Cytarabine
- BIOLOGICAL Blinatumomab
- PROCEDURE Bone Marrow Aspiration and Biopsy
Study Locations (20)
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
California
- 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
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
Arkansas
- Mercy Hospital Fort Smith — Fort Smith
Connecticut
- Yale University — New Haven
Georgia
- Augusta University Medical Center — Augusta
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04530565
The ClinicalTrials.gov registry entry for NCT04530565 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 348 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04530565 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Alaska, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04530565 about?
NCT04530565 is a clinical study titled "Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults". This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The in...
What is the current status of trial NCT04530565?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2021-01-25. Estimated completion is 2028-07-01.
What conditions does trial NCT04530565 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04530565?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Cytarabine (DRUG), Blinatumomab (BIOLOGICAL), Bone Marrow Aspiration and Biopsy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04530565?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04530565 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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