|
|
|
|
| LEADER |
01000caa a22002652 4500 |
| 001 |
CTG004354346 |
| 003 |
DE-627 |
| 005 |
20230425175145.0 |
| 007 |
cr uuu---uuuuu |
| 008 |
210507s2019 xx |||||o 00| ||eng c |
| 035 |
|
|
|a (DE-627)CTG004354346
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)EUCTR2012-004092-40-PL
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)CAMN107I2201
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)2012-004092-40-SE
|
| 040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
| 041 |
|
|
|a eng
|
| 245 |
1 |
0 |
|a A clinical research study evaluating the possibility to suspend the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients who have very small amount of leukemia cells remaining after nilotinib (Tasigna) treatment.
|b A single-arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disease (MRD) status on first line nilotinib treatment
|
| 264 |
|
1 |
|c 2019
|
| 336 |
|
|
|a Text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a Computermedien
|b c
|2 rdamedia
|
| 338 |
|
|
|a Online-Ressource
|b cr
|2 rdacarrier
|
| 500 |
|
|
|a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 29-03-2013, Last updated: 2022-11-24
|
| 650 |
|
4 |
|a Medical Condition: Adult patients treated with a planned dose of nilotinib 300 mg BID (or at a reduced dose level of 400 mg QD if required from the perspective of tolerance) for a minimum of 2 calendar years for newly diagnosed BCR-ABL positive Chronic Myelogenous Leukemia in chronic phase and have achieved MR 4.5 (BCR-ABL = 0.0032% IS) at any time point before being enrolled in the study MedDRA version: 21.0 Level: LLT Classification code 10054352 Term: Chronic phase chronic myeloid leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
|
| 650 |
|
4 |
|a Study Type: Interventional
|
| 650 |
|
4 |
|a Phase: Phase 2
|
| 650 |
|
4 |
|a Recruitment Status: Authorised-recruitment may be ongoing or finished
|
| 650 |
|
4 |
|a 610
|
| 773 |
0 |
8 |
|i Enthalten in
|t WHO International Clinical Trials Registry Platform
|g (2019) vom: 16. Dez.
|
| 773 |
1 |
8 |
|g year:2019
|g day:16
|g month:12
|
| 856 |
4 |
0 |
|u https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004092-40
|z kostenfrei
|3 Volltext
|
| 912 |
|
|
|a GBV_CTG
|
| 912 |
|
|
|a SSG-OLC-PHA
|
| 951 |
|
|
|a AR
|
| 952 |
|
|
|j 2019
|b 16
|c 12
|
Klinische Studie