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NCT04530565 · ClinicalTrials.gov registry record · Phase 3

Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults

A Phase 3 study of B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 3
Development phase
348
Enrollment target
20
Study locations

NCT04530565: Recruiting Phase 3 study of B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, sponsored by National Cancer Institute (NCI).

NCT04530565 is a Phase 3 study of B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 348 participants, above the 128-participant average among 8 other B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 trials with a reported enrollment target (172% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04530565, a Phase 3 study of B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 3
Development phase
348 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Will compare OS following induction with steroids + tyrosine kinase inhibitor (TKI) + blinatumomab and induction with steroids + TKI + chemotherapy. Will be based on an intent-to-treat analysis. Estimates of OS including medians and confidence intervals, will be calculated using the Kaplan-Meier method. Comparisons of OS between treatment arms will be conducted using the one-sided stratified log-rank test, stratified on the same factors used in the randomization. Cox proportional hazards models

Conditions Studied

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

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

FieldValue
Enrollment Target 348 participants
Start Date 2021-01-25
Est. Completion 2028-07-01
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What NCT04530565 shows while recruiting

NCT04530565 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, above the 128-participant average among 8 other B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 trials with a reported enrollment target (172% higher).

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.

NCT04530565 names 20 study sites across 7 states, led by Alaska, California, Alabama.

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.

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).

Who is sponsoring clinical trial NCT04530565?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

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 NCT04530565's enrollment target sits among peer trials

348 2nd of 8 the highest of 8 other B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 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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More recruiting context for NCT04530565

Source: ClinicalTrials.gov NCT04530565, the US trial registry maintained by the National Library of Medicine. NCT04530565 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.