Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

NCT ID: NCT05282108

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2026-11-30

Brief Summary

The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

Detailed Description

This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.

Conditions

Chronic Myeloid Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Carcemia group

The cohort treated with Carcemia

Carcemia

Intervention Type: DRUG

Generic Imatinib

Glivec Group

The cohort treated with Glivec

Glivec

Intervention Type: DRUG

Imatinib

Interventions

Carcemia

Generic Imatinib

Intervention Type: DRUG

Glivec

Imatinib

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years

2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis

3. Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment

4. Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range

5. Written informed consent

Exclusion Criteria

1. CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis 2. CML in BP at enrolment 3. Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hikma Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Institute (NCI)

Cairo, , Egypt

Site Status: RECRUITING

Ain Shams University Hospital

Cairo, , Egypt

Site Status: NOT_YET_RECRUITING

Nasser Institute

Cairo, , Egypt

Site Status: RECRUITING

Tanta Oncology Center

Tanta, , Egypt

Site Status: NOT_YET_RECRUITING

Countries

Egypt

Central Contacts

Ruba A Jaber

Role: CONTACT

rjaber@Hikma.com

+96265805430 ext. 11663

References

Ercaliskan A, Seyhan Erdogan D, Eskazan AE. Current evidence on the efficacy and safety of generic imatinib in CML and the impact of generics on health care costs. Blood Adv. 2021 Sep 14;5(17):3344-3353. doi: 10.1182/bloodadvances.2021004194.

Reference Type: BACKGROUND

PMID: 34477815 (View on PubMed)

Abou Dalle I, Kantarjian H, Burger J, Estrov Z, Ohanian M, Verstovsek S, Ravandi F, Borthakur G, Garcia-Manero G, Jabbour E, Cortes J. Efficacy and safety of generic imatinib after switching from original imatinib in patients treated for chronic myeloid leukemia in the United States. Cancer Med. 2019 Nov;8(15):6559-6565. doi: 10.1002/cam4.2545. Epub 2019 Sep 10.

Reference Type: BACKGROUND

PMID: 31502383 (View on PubMed)

Awidi A, Abbasi S, Alrabi K, Kheirallah KA. Generic Imatinib Therapy Among Jordanians: An Observational Assessment of Efficacy and Safety in Routine Clinical Practice. Clin Lymphoma Myeloma Leuk. 2017 Dec;17(12):e55-e61. doi: 10.1016/j.clml.2017.08.001. Epub 2017 Aug 5.

Reference Type: BACKGROUND

PMID: 28844599 (View on PubMed)

Danthala M, Gundeti S, Kuruva SP, Puligundla KC, Adusumilli P, Karnam AP, Bala S, Konatam ML, Maddali LS, Digumarti RR. Generic Imatinib in Chronic Myeloid Leukemia: Survival of the Cheapest. Clin Lymphoma Myeloma Leuk. 2017 Jul;17(7):457-462. doi: 10.1016/j.clml.2017.05.006. Epub 2017 May 10.

Reference Type: BACKGROUND

PMID: 28559151 (View on PubMed)

Jiang H, Zhi LT, Hou M, Wang JX, Wu DP, Huang XJ. [Comparison of generic and original imatinib in the treatment of newly diagnosed patients with chronic myelogenous leukemia in chronic phase: a multicenter retrospective clinical study]. Zhonghua Xue Ye Xue Za Zhi. 2017 Jul 14;38(7):566-571. doi: 10.3760/cma.j.issn.0253-2727.2017.07.003. Chinese.

Reference Type: BACKGROUND

PMID: 28810322 (View on PubMed)

Gemelli M, Elli EM, Elena C, Iurlo A, Intermesoli T, Maffioli M, Pungolino E, Carraro MC, D'Adda M, Lunghi F, Anghileri M, Polverelli N, Rossi M, Bacciocchi M, Bono E, Bucelli C, Passamonti F, Antolini L, Gambacorti-Passerini C. Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study. Blood Res. 2020 Sep 30;55(3):139-145. doi: 10.5045/br.2020.2020130.

Reference Type: BACKGROUND

PMID: 32792470 (View on PubMed)

Deininger MW, Shah NP, Altman JK, Berman E, Bhatia R, Bhatnagar B, DeAngelo DJ, Gotlib J, Hobbs G, Maness L, Mead M, Metheny L, Mohan S, Moore JO, Naqvi K, Oehler V, Pallera AM, Patnaik M, Pratz K, Pusic I, Rose MG, Smith BD, Snyder DS, Sweet KL, Talpaz M, Thompson J, Yang DT, Gregory KM, Sundar H. Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020 Oct 1;18(10):1385-1415. doi: 10.6004/jnccn.2020.0047.

Reference Type: BACKGROUND

PMID: 33022644 (View on PubMed)

Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2016 update on diagnosis, therapy, and monitoring. Am J Hematol. 2016 Feb;91(2):252-65. doi: 10.1002/ajh.24275.

Reference Type: BACKGROUND

PMID: 26799612 (View on PubMed)

Baccarani M, Cortes J, Pane F, Niederwieser D, Saglio G, Apperley J, Cervantes F, Deininger M, Gratwohl A, Guilhot F, Hochhaus A, Horowitz M, Hughes T, Kantarjian H, Larson R, Radich J, Simonsson B, Silver RT, Goldman J, Hehlmann R; European LeukemiaNet. Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol. 2009 Dec 10;27(35):6041-51. doi: 10.1200/JCO.2009.25.0779. Epub 2009 Nov 2.

Reference Type: BACKGROUND

PMID: 19884523 (View on PubMed)

Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Muller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saussele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM, Hehlmann R. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013 Aug 8;122(6):872-84. doi: 10.1182/blood-2013-05-501569. Epub 2013 Jun 26.

Reference Type: BACKGROUND

PMID: 23803709 (View on PubMed)

Hochhaus A, Baccarani M, Silver RT, Schiffer C, Apperley JF, Cervantes F, Clark RE, Cortes JE, Deininger MW, Guilhot F, Hjorth-Hansen H, Hughes TP, Janssen JJWM, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Mayer J, Nicolini F, Niederwieser D, Pane F, Radich JP, Rea D, Richter J, Rosti G, Rousselot P, Saglio G, Saussele S, Soverini S, Steegmann JL, Turkina A, Zaritskey A, Hehlmann R. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020 Apr;34(4):966-984. doi: 10.1038/s41375-020-0776-2. Epub 2020 Mar 3.

Reference Type: BACKGROUND

PMID: 32127639 (View on PubMed)

O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ; IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004. doi: 10.1056/NEJMoa022457.

Reference Type: BACKGROUND

PMID: 12637609 (View on PubMed)

Kantarjian H, O'Brien S, Jabbour E, Shan J, Ravandi F, Kadia T, Faderl S, Garcia-Manero G, Borthakur G, Cortes J. Impact of treatment end point definitions on perceived differences in long-term outcome with tyrosine kinase inhibitor therapy in chronic myeloid leukemia. J Clin Oncol. 2011 Aug 10;29(23):3173-8. doi: 10.1200/JCO.2010.33.4169. Epub 2011 Jul 11.

Reference Type: BACKGROUND

PMID: 21747082 (View on PubMed)

Deininger MW, O'Brien SG, Ford JM, Druker BJ. Practical management of patients with chronic myeloid leukemia receiving imatinib. J Clin Oncol. 2003 Apr 15;21(8):1637-47. doi: 10.1200/JCO.2003.11.143. Epub 2003 Mar 13.

Reference Type: BACKGROUND

PMID: 12668652 (View on PubMed)

Other Identifiers

HIK-CAR-2021-04

Identifier Type: -

Identifier Source: org_study_id