Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02828358 · ClinicalTrials.gov registry record · Phase 2

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

A Phase 2 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
78
Enrollment target
20
Study locations

NCT02828358 is a Phase 2 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 78 participants, below the 397-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 6 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02828358, a Phase 2 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
78 participants
Enrollment target
20
Study locations

Study Summary

This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine sulfate, pegaspargase, hydrocortisone sodium succinate, azacitidine, cyclophosphamide, mercaptopurine, leucovorin calcium, 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. Giving more than one drug may kill more cancer cells.

Interventions

  • DRUG Cyclophosphamide
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Azacitidine
  • DRUG Cytarabine

Study Locations (20)

California

  • Kaiser Permanente Downey Medical Center - Downey
  • Loma Linda University Medical Center - Loma Linda
  • Children's Hospital Los Angeles - Los Angeles
  • Cedars Sinai Medical Center - 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
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • UCSF Medical Center-Mission Bay - San Francisco
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance

Alabama

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

Arizona

  • Banner Children's at Desert - Mesa
  • Phoenix Childrens Hospital - Phoenix

Colorado

  • Children's Hospital Colorado - Aurora
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver

Alaska

  • Providence Alaska Medical Center - Anchorage

Arkansas

  • Arkansas Children's Hospital - Little Rock

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2017-04-01
Est. Completion 2024-12-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02828358

The ClinicalTrials.gov registry entry for NCT02828358 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 397-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (80% 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 Mixed Phenotype Acute Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT02828358 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT02828358 about?

NCT02828358 is a clinical study titled "Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement". This pilot phase II trial studies the side effects of azacitidine and combination chemotherapy in infants with acute lymphoblastic leukemia and KMT2A gene rearrangement. Drugs used in chemotherapy, such as methotrexate, prednisolone, daunorubicin hydrochloride, cytarabine, dexamethasone, vincristine...

What is the current status of trial NCT02828358?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2017-04-01. Estimated completion is 2024-12-31.

What conditions does trial NCT02828358 study?

This clinical trial studies the following conditions: Mixed Phenotype Acute Leukemia, B Acute Lymphoblastic Leukemia, Acute Leukemia of Ambiguous Lineage.

What interventions are being tested in trial NCT02828358?

The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Azacitidine (DRUG), Cytarabine (DRUG).

Who is sponsoring clinical trial NCT02828358?

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

Where is trial NCT02828358 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.

Similar trials for Mixed Phenotype Acute Leukemia

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.