Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

NCT01254188 | Completed Phase 3 Results

• 1 other identifier: CAMN107E2401
• Study Type: interventional
• Target: 421
• Locations: 19 countries
• Sites: 100

Brief Summary

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemia,; CML,; nilotinib,; myelogenous,; Philadelphia chromosome

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients Achieving MMR by 12 Months

  MMR is defined as BCR-ABL ratio (%) on IS \<= 0.1% (corresponds to \>=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method

  12 months

Secondary Outcomes (7)

• Time to Molecular Response at 24 Months

  24 months

• Duration of Major Molecular Response

  3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected

• Complete Cytogenetic Response

  6 months

• Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.

  6,12,18 and 24 months

• Overall Survival

  3, 6, 9, 12, 15, 18, 21, 24 Months

Study Arms (1)

Nilotinib

EXPERIMENTAL

300 mg BID

Drug: Nilotinib

Interventions

Nilotinib DRUG

This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.

Also known as: AMN107

Nilotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

You may not qualify if:

• Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
• Uncontrolled congestive heart failure or hypertension
• Myocardial infarction or unstable angina pectoris within past 12 months
• Known T315I mutations
• QTcF \>450 msec
• Significant arrhythmias

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (100)

Novartis Investigative Site

Algiers, Bouzareah, 16000, Algeria

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Oran, 31000, Algeria

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Buenos Aires, Buenos Aires, C1114AAN, Argentina

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Caba, Buenos Aires, C1221ADC, Argentina

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Paraná, Entre Ríos Province, E3100BBJ, Argentina

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Canberra, Australian Capital Territory, 2605, Australia

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Concord NSW, New South Wales, 2139, Australia

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Gosford, New South Wales, 2250, Australia

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Kingswood, New South Wales, 2747, Australia

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Kogarah, New South Wales, 2217, Australia

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Liverpool, New South Wales, 2170, Australia

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St Leonards, New South Wales, 2065, Australia

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Westmead, New South Wales, 2145, Australia

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Douglas, Queensland, 4810, Australia

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Woolloongabba, Queensland, 4102, Australia

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Adelaide, South Australia, 5000, Australia

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Bedford Park, South Australia, 5042, Australia

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Hobart, Tasmania, 7000, Australia

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Box Hill, Victoria, 3128, Australia

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Clayton, Victoria, 3168, Australia

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Fitzroy, Victoria, 3065, Australia

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Heidelberg, Victoria, 3084, Australia

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Parkville, Victoria, 3050, Australia

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Wodonga, Victoria, 3690, Australia

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Nedlands, Western Australia, 6009, Australia

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Perth, Western Australia, 6000, Australia

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Salvador, Estado de Bahia, 41253-190, Brazil

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Goiânia, Goiás, 74605-020, Brazil

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Curitiba, Paraná, 81520-060, Brazil

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Porto Alegre, Rio Grande do Sul, 90430-091, Brazil

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Edmonton, Alberta, T6G 1Z2, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, V6Z1Y6, Canada

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Moncton, New Brunswick, E1C 6Z8, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Barrie, Ontario, L4M 6M2, Canada

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Brampton, Ontario, L6R 3J7, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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London, Ontario, N6A 4G5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Weston, Ontario, M9N 1N8, Canada

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Windsor, Ontario, N8W 2X3, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Saskatoon, Saskatchewan, S7N 4H4, Canada

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Cairo, Cairo Governorate, 11566, Egypt

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Al Mansurah, 35516, Egypt

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Alexandria, 21131, Egypt

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Cairo, Egypt

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Tamil Nadu, Chennai, 600035, India

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Pune, Maharashtra, 411004, India

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Vellore, Tamil Nadu, 632004, India

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Jerusalem, 9112001, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 5266202, Israel

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Beirut, 166830, Lebanon

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Saida, 652, Lebanon

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Kuala Selangor, 68000, Malaysia

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Pulau Pinang, 10990, Malaysia

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San Luis Potosí City, San Luis Potosí, 78416, Mexico

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Hermosillo, Sonora, 83000, Mexico

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Muscat, 123, Oman

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Arkhangelsk, Russia, 163045, Russia

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Novosibirsk, Russia, 630051, Russia

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Perm, Russia, 614077, Russia

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Ryazan, Russia, 390039, Russia

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Saint Petersburg, Russia, 197341, Russia

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Tyumen, Russia, 625023, Russia

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Irkutsk, 664079, Russia

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Moscow, 125167, Russia

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Moscow, 125284, Russia

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Nizhny Novgorod, 603126, Russia

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Rostov-on-Don, 344022, Russia

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Rostov-on-Don, 344090, Russia

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Saint Petersburg, 191024, Russia

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Saint Petersburg, 197022, Russia

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Tula, 300053, Russia

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Yekaterinburg, 620137, Russia

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Dammam, 15215, Saudi Arabia

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Jeddah, 21423, Saudi Arabia

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Jeddah, 21499, Saudi Arabia

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Riyadh, 11211, Saudi Arabia

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Riyadh, 11426, Saudi Arabia

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Soweto, Gauteng, 2013, South Africa

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Bloemfontein, 9301, South Africa

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Observatory, 7925, South Africa

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Parktown, 2193, South Africa

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Pretoria, 0002, South Africa

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Niaosong Township, Taiwan, 83301, Taiwan

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Taichung, Taiwan, 40447, Taiwan

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Taipei, Taiwan, ROC, 112, Taiwan

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Novartis Investigative Site

Linkou District, 33305, Taiwan

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Chiang Mai, 50200, Thailand

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Muang, 40002, Thailand

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Sousse, Tunisie, 4000, Tunisia

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Tunis, 1008, Tunisia

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Novartis Investigative Site

Dubai, United Arab Emirates

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Related Publications (1)

• Hughes TP, Munhoz E, Aurelio Salvino M, Ong TC, Elhaddad A, Shortt J, Quach H, Pavlovsky C, Louw VJ, Shih LY, Turkina AG, Meillon L, Jin Y, Acharya S, Dalal D, Lipton JH. Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd. Br J Haematol. 2017 Oct;179(2):219-228. doi: 10.1111/bjh.14829. Epub 2017 Jul 12.

  PMID: 28699641 DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Translocation, Genetic; Chromosome Aberrations

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: April 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 3, 2016
• Results First Posted: March 3, 2016

Record last verified: 2016-02

Locations

CA (18); EG (4); MY (2); ME (2); AU (21); ZA (5); TH (2); TU (2); AE (1); IL (3); RU (16); AR (3); SA (5); BR (4); TW (4); OM (1); AL (2); IN (3); LE (2)