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Chronic Myeloid LeukemiaCARCMLNCT05282108

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

An observational study of Chronic Myeloid Leukemia, run by Hikma Pharmaceuticals LLC at 4 sites in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Carcemia and Glivec
How many people
240 participants
Where
4 sitesEgypt
Study dates
20 Jul 2022to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be recruited from different sites in Egypt

Who may be able to join

  • Age ≥18 years
  • Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
  • Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
  • 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
  • Written informed consent

Who cannot join

  • 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.
  • -

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ruba A Jaber contact

+96265805430 ext. 11663

rjaber@Hikma.com

Egypt4 sites, 4 recruiting

  • National Cancer Institute (NCI)

    Cairo, 11796

    Recruiting

  • Ain Shams University Hospital

    Cairo

    Not yet recruiting

  • Nasser Institute

    Cairo

    Recruiting

  • Tanta Oncology Center

    Tanta

    Not yet recruiting

Other trials in Egypt

About this study

Official title: Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia; a Multicenter, Observational Study

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

Read the 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.

Being tested
Carcemia, Glivec
Keywords
Imatinib, Carcemia, Leukemia, Cohort study, Effectiveness, Safety, Observational study, Cancer, Blood cancer, Health related qulaity of life, Glivec
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Neoplasms, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarcemiaDrug

    Generic Imatinib

  • GlivecDrug

    Imatinib

Study groups in NCT05282108
Study groupRoleWhat they receive
Carcemia groupThe cohort treated with Carcemia
Receives: Drug: Carcemia
Glivec GroupThe cohort treated with Glivec
Receives: Drug: Glivec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months

    Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months using RQ-PCR test (Appendix II) using Chi-square test. The MMR is defined as ration of BCR-ABL to ABL (or other housekeeping gene) ≤ 0.1% on the international scale (MMR is equal to a 3-log reduction in the ratio of BCR-ABL1: ABL from a standardized median baseline value).

    Measured: 12 months

Secondary outcomes (8)

  1. the safety & tolerability of imatinib after 12 months

    In both cohorts, the safety \& tolerability of imatinib after 12 months of treatment will be assessed by:

    • The number, type, severity and frequency of the adverse reactions particularly those described in the SmPC of the reference product.
    • Incidence of adverse events (AEs) \& serious adverse events (SAEs).
    • AEs leading to permanent treatment discontinuation.
    • Clinically relevant changes in laboratory tests (according to laboratory reference ranges).

    Measured: 12 months

  2. Progression free survival (PFS) at 12 months

    Measured: 12 months

  3. Event free survival (EFS) at 12 months

    Measured: 12 months

  4. Survival without blastic phase (BP) at 12 months

    Measured: 12 months

  5. Overall survival (OS) at 12 months

    Measured: 12 months

  6. Complete cytogenetic response (CCyR) at 12 months

    Measured: 12 months

  7. Deep Molecular response (DMR) at 12 months

    Measured: 12 months

  8. Treatment compliance

    Treatment compliance while on imatinib will be evaluated by identifying the frequency of not taking the medications as prescribed and the reason behind that based on the prescription pattern. The decision on non-compliance is based on the treating physician's judgment."

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start20 Jul 2022
  3. Primary completionAug 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05282108
Sponsor's protocol ID
HIK-CAR-2021-04
Acronym
CARCML
Status last verified
Mar 2025
First submitted
3 Mar 2022
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34477815

  • 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.

    PubMed 31502383

  • 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.

    PubMed 28844599

  • 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.

    PubMed 28559151

  • 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.

    PubMed 28810322

  • 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.

    PubMed 32792470

  • 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.

    PubMed 33022644

  • 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.

    PubMed 26799612

  • 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.

    PubMed 19884523

  • 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.

    PubMed 23803709

  • 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.

    PubMed 32127639

  • 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.

    PubMed 12637609

  • 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.

    PubMed 21747082

  • 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.

    PubMed 12668652

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Myeloid Leukemia, run by Hikma Pharmaceuticals LLC at 4 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruba A Jaber (+96265805430 ext. 11663, rjaber@Hikma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05282108, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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