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NCT03914625 · ClinicalTrials.gov registry record · Phase 3

A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia

A Phase 3 study of Down Syndrome and B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
6,720
Enrollment target
20
Study locations

NCT03914625 is a Phase 3 study of Down Syndrome and B Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 6,720 participants, above the 2,347-participant average among 54 other Down Syndrome trials with a reported enrollment target (186% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT03914625, a Phase 3 study of Down Syndrome and B Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
6,720 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Conditions Studied

Down Syndrome B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Dexamethasone
  • DRUG Cytarabine
  • BIOLOGICAL Blinatumomab
  • DRUG Asparaginase Erwinia chrysanthemi

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center - Downey
  • City of Hope Comprehensive Cancer Center - Duarte
  • Loma Linda University Medical Center - Loma Linda
  • Miller Children's and Women's Hospital Long Beach - Long Beach
  • Children's Hospital Los Angeles - Los Angeles
  • Cedars Sinai Medical Center - Los Angeles
  • Mattel Children's Hospital UCLA - 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

Arizona

  • Banner Children's at Desert - Mesa
  • Phoenix Childrens Hospital - Phoenix
  • Banner University Medical Center - Tucson - Tucson

Alabama

  • Children's Hospital of Alabama - Birmingham
  • USA Health Strada Patient Care Center - Mobile

Alaska

  • Providence Alaska Medical Center - Anchorage

Arkansas

  • Arkansas Children's Hospital - Little Rock

Trial Details

FieldValue
Enrollment Target 6,720 participants
Start Date 2019-07-03
Est. Completion 2027-09-30
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT03914625

The ClinicalTrials.gov registry entry for NCT03914625 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 6,720 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,347-participant average among 54 other Down Syndrome trials with a reported enrollment target (186% higher). 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 Down Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT03914625 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT03914625 about?

NCT03914625 is a clinical study titled "A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia". This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in th...

What is the current status of trial NCT03914625?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 6,720 participants. The study started on 2019-07-03. Estimated completion is 2027-09-30.

What conditions does trial NCT03914625 study?

This clinical trial studies the following conditions: Down Syndrome, B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma.

What interventions are being tested in trial NCT03914625?

The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Blinatumomab (BIOLOGICAL), Asparaginase Erwinia chrysanthemi (DRUG).

Who is sponsoring clinical trial NCT03914625?

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

Where is trial NCT03914625 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.