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COMPLETED Phase 2

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

NCT02828358 · View on ClinicalTrials.gov ↗

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02828358

The ClinicalTrials.gov registry entry for NCT02828358 describes a study currently listed as completed. It is categorized as Phase 2, 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 78 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 3 conditions, with Mixed Phenotype Acute Leukemia 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: NCT02828358 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02828358?

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 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.

Related

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