Who is sponsoring NCT01294618?

NCT01294618 is sponsored by Hospices Civils de Lyon.

What condition does NCT01294618 study?

NCT01294618 studies Chronic Myelogenous Leukemia.

Is NCT01294618 still recruiting?

NCT01294618 is currently completed. Last updated 23 May 2019.

Last reviewed 2019-05-23 · How we verify

NCT01294618: NILOPEG

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

"Phase II Multicenter Study Evaluating the Efficacy and the Safety of a Combination of Nilotinib Plus Pegylated Interferon Alpha 2a for de Novo Chronic Phase Chronic Myelogenous Leukemia Patients"

Completed Phase 2 Last updated 23 May 2019

What this trial tests

Phase 2 trial testing Nilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice. in Chronic Myelogenous Leukemia in 60 participants. Completed in 1 September 2013.

Timeline

1 March 2011

Primary endpoint
1 March 2011

1 September 2013

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 March 2011
Primary completion	1 March 2011
Estimated completion	1 September 2013
Sites	1 location across France

Drugs / interventions tested

Nilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.

Conditions studied

Chronic Myelogenous Leukemia — all drugs for Chronic Myelogenous Leukemia →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Chronic Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Cumulative incidence of complete molecular remissions after 12 months of treatment with nilotinib + Pegylated Interferon (PEG-IFN)
Time frame: 24 months
The trial opens for enrolment in 2011 March 7th for 18 months. Each patient will be followed for 24 months after entry.

Sponsor's own description

The aim of this study is to demonstrate the safety and the efficacy of a combination of 2 treatments shown to have some efficacy in Chronic Phase Chronic Myelogenous Leukemia (CP CML) separately, but that have never been combined to date, and this combination is expected to substantially increase the molecular response rates.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Re-emergence of interferon-α in the treatment of chronic myeloid leukemia.
Talpaz M, Hehlmann R, Quintás-Cardama A, Mercer J, et al · · 2013 · cited 95× · PMID 23238589 · DOI 10.1038/leu.2012.313
To wake up cancer stem cells, or to let them sleep, that is the question.
Takeishi S, Nakayama KI. · · 2016 · cited 84× · PMID 27116333 · DOI 10.1111/cas.12958
Trial Watch: Immunostimulatory cytokines.
Vacchelli E, Galluzzi L, Eggermont A, Galon J, et al · · 2012 · cited 70× · PMID 22754768 · DOI 10.4161/onci.20459
Combination Therapies in Chronic Myeloid Leukemia for Potential Treatment-Free Remission: Focus on Leukemia Stem Cells and Immune Modulation.
Mu H, Zhu X, Jia H, Zhou L, et al · · 2021 · cited 23× · PMID 34055612 · DOI 10.3389/fonc.2021.643382
Tyrosine kinase inhibitors and interferon.
Dimou M, Panayiotidis P. · · 2014 · cited 5× · PMID 24455115 · DOI 10.4084/mjhid.2014.006

Verify or expand the search:

Other recruiting trials for Chronic Myelogenous Leukemia

Currently open trials in the same condition.

NCT06680661 — ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis · Phase 2 · recruiting
NCT06088888 — TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia · Phase 1 · recruiting
NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
NCT05805605 — Allo HSCT Using RIC and PTCy for Hematological Diseases · Phase 2 · recruiting
NCT04877522 — Asciminib Roll-over Study · Phase 4 · recruiting

Other Hospices Civils de Lyon trials

Trials by the same sponsor.

NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01294618 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
Last refreshed: 23 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01294618.

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