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NCT05282108: CARCML
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
trial testing Carcemia in Chronic Myeloid Leukemia in 240 participants. Currently enrolling.
1 August 2026
Quick facts
| Lead sponsor | Hikma Pharmaceuticals LLC |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 240 |
| Start date | 20 July 2022 |
| Primary completion | 1 August 2026 |
| Estimated completion | 1 November 2026 |
| Sites | 4 locations across Egypt |
Drugs / interventions tested
Conditions studied
- Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
Sponsor
Hikma Pharmaceuticals LLC — full company profile →
Who can join
18 and older, any sex, with Chronic Myeloid 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.
-
Proportion of patients who achieve and maintain major molecular response (MMR) at 12 months
Time frame: 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).
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05282108
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Myeloid Leukemia
Currently open trials in the same condition.
- NCT06817720 — Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chroni · Phase 2 · recruiting
- NCT07238712 — Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies · Phase 2 · recruiting
- NCT06453902 — TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients · Phase 2 · recruiting
- NCT06390306 — The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP · recruiting
- NCT06355583 — Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial · Phase 2 · recruiting
Other Hikma Pharmaceuticals LLC trials
Trials by the same sponsor.
- NCT06326697 — Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML) · Phase 1 · completed
- NCT05423769 — Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclero · completed
- NCT05563818 — Using Speech to Monitor Symptom Severity in Arabic Speaking Patients With Schizophrenia · completed
- NCT04468165 — Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical · completed
- NCT03625388 — Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05282108 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hikma Pharmaceuticals LLC
- Last refreshed: 23 March 2025
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/NCT05282108.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing