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NCT02204722: IDEAL
A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients
Phase 4 trial testing 600mg/day of Imatinib in Chronic Myeloid Leukemia in 55 participants. Terminated before completion.
23 May 2017
Quick facts
| Lead sponsor | Dong-A ST Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 13 October 2014 |
| Primary completion | 23 May 2017 |
| Estimated completion | 9 January 2018 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- 600mg/day of Imatinib — full drug profile →
- 400mg/day of Imatinib — full drug profile →
Conditions studied
- Chronic Myeloid Leukemia — all drugs for Chronic Myeloid Leukemia →
Sponsor
Dong-A ST Co., Ltd. — full company profile →
Who can join
18 and older, any sex, with Chronic Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level after three month dosing and be maintained their dose of 400mg/day. On the other hand, the group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. The superiority of the group B will be proved by evaluating the MMR rate of these two groups after 12 months of administeration of Imatinib.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02204722
- 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 Dong-A ST Co., Ltd. trials
Trials by the same sponsor.
- NCT07342062 — Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fed State · Phase 1 · completed
- NCT07297940 — Pharmacokinetics and Safety Profiles of DA-1229_01 in Healthy Subjects at Fasting State · Phase 1 · completed
- NCT07027982 — A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjec · Phase 1 · completed
- NCT07046715 — Clinical Trial Comparing Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 · Phase 1 · completed
- NCT07007533 — A Study to Compare and Evaluate the Safety, Tolerability and Pharmacokinetics Between DA-5223 and DA-5223-R in Healthy A · Phase 1 · 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 NCT02204722 (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 Dong-A ST Co., Ltd.
- Last refreshed: 15 June 2018
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/NCT02204722.
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