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NCT01735955 · ClinicalTrials.gov registry record · Phase 4

Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study

A Phase 4 study of Acute Lymphoblastic Leukemia (ALL) and Chronic Myelogenous Leukemia (CML), sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 4
Development phase
57
Enrollment target
20
Study locations

NCT01735955 is a Phase 4 study of Acute Lymphoblastic Leukemia (ALL) and Chronic Myelogenous Leukemia (CML) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 57 participants, below the 6,302-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01735955, a Phase 4 study of Acute Lymphoblastic Leukemia (ALL) and Chronic Myelogenous Leukemia (CML), has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 4
Development phase
57 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the treatment as judged by the investigator

Conditions Studied

Acute Lymphoblastic Leukemia (ALL) Chronic Myelogenous Leukemia (CML) Metastatic Gastrointestinal Stromal Tumors (GIST) Receptor Tyrosine Kinase (KIT) Mutated Melanoma

Interventions

  • DRUG Nilotinib

Study Locations (20)

Other

  • Novartis Investigative Site - Vienna
  • Novartis Investigative Site - Lille
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Hong Kong SAR
  • Novartis Investigative Site - Budapest
  • Novartis Investigative Site - Budapest
  • Novartis Investigative Site - Haifa
  • Novartis Investigative Site - Amsterdam
  • Novartis Investigative Site - Leiden

Ontario

  • Novartis Investigative Site - Hamilton
  • Novartis Investigative Site - Toronto

New York

  • Novartis Investigative Site - Albany

Texas

  • Novartis Investigative Site - Houston

British Columbia

  • Novartis Investigative Site - Vancouver

Nova Scotia

  • Novartis Investigative Site - Halifax

BO

  • Novartis Investigative Site - Bologna

GE

  • Novartis Investigative Site - Genova

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2013-03-29
Est. Completion 2023-07-07
Phase Phase 4

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01735955

The ClinicalTrials.gov registry entry for NCT01735955 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,302-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Acute Lymphoblastic Leukemia (ALL) appearing as the primary indexed condition, and to 1 intervention - of which Nilotinib is the first listed.

NCT01735955 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Ontario, New York.

Frequently Asked Questions

What is clinical trial NCT01735955 about?

NCT01735955 is a clinical study titled "Study to Allow Access to Nilotinib for Patients Who Are on Nilotinib Treatment in a Novartis-sponsored Study". The purpose of this study was to allow continued use of nilotinib in patients who were on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and were benefiting from the treatment as judged by the investigator

What is the current status of trial NCT01735955?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 57 participants. The study started on 2013-03-29. Estimated completion is 2023-07-07.

What conditions does trial NCT01735955 study?

This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Metastatic Gastrointestinal Stromal Tumors (GIST), Receptor Tyrosine Kinase (KIT) Mutated Melanoma.

What interventions are being tested in trial NCT01735955?

The interventions under investigation include: Nilotinib (DRUG).

Who is sponsoring clinical trial NCT01735955?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01735955 being conducted?

This trial has 20 study locations across New York, Texas, British Columbia, Nova Scotia, Ontario. 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.