To compare proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm
ID
Bron
Verkorte titel
Aandoening
Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Compare proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm [ Time Frame: 12 Months ] [ Designated as safety issue: No ]<br>
MMR is defined as <0.1%Bcr-Abl1 on the International Scale (IS) by Real Time Quantitative Polymerase Chain Reaction (RT-PCR)
Doel van het onderzoek
To compare proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm
Onderzoeksopzet
12 Months
18 Months
5 Years
See outcomes
Onderzoeksproduct en/of interventie
The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to 5 years (240 weeks) after randomization.
Algemeen / deelnemers
De Boelelaan 1117
J.J.W.M. Janssen
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442604
jjwm.janssen@vumc.nl
Wetenschappers
De Boelelaan 1117
J.J.W.M. Janssen
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4442604
jjwm.janssen@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Molecular diagnosis of CP CML of < 6 months (from initial diagnosis)
2. Adequate hepatic, renal and pancreatic function
3. Age > 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment.
2. Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.
3. Extramedullary disease only.
4. Major surgery or radiotherapy within 14 days of randomization.
5. History of clinically significant or uncontrolled cardiac disease.
6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C or evidence of decompensated liver disease or cirrhosis.
7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.
8. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.
9. Current, or recent (within 6 months), participation in other clinical trials.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4723 |
| NTR-old | NTR4868 |
| Ander register | NL48355.029.14 : NCT02130557 |