Tasigna and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study (TIGER)
|ClinicalTrials.gov Identifier: NCT01657604|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2012
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Peginterferon α2b Drug: Nilotinib||Phase 3|
- Evaluation of the major molecular response (MMR) rate at 18 months of nilotinib compared to nilotinib+pegylated Interferon alpha (IFN) in adult patients with newly diagnosed Ph/BCR-ABL CML in chronic phase.
- Evaluation of the feasibility to discontinue drug therapy in stable deep molecular response (MR4) after nilotinib versus IFN maintenance therapy.
- Evaluation of the efficacy and tolerability of IFN added to nilotinib 2x300 mg/day.
- Evaluation of the efficacy and tolerability of a maintenance therapy with nilotinib versus IFN after stable MMR after at least 24 months of nilotinib therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||717 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Optimization of Newly Diagnosed Ph/BCR-ABL Positive Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase With Nilotinib vs. Nilotinib Plus Interferon Alpha Induction and Nilotinib or Interferon Alpha Maintenance Therapy|
|Actual Study Start Date :||August 24, 2012|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2022|
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily with Peginterferon α2b at a starting target dose of 30μg/week.
Drug: Peginterferon α2b
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily with at a starting target dose of 30μg/week. After confirmed MMR or at least 24 mo. after start of therapy, maintenance therapy (nilotinib will be discontinued) will start for a study duration of up to 5 years.
Other Name: Redipen
Active Comparator: Nilotinib
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily.
Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily for a study duration of up to 5 years.
Other Name: Tasigna
- MMR rate at 18 months of nilotinib monotherapy versus nilotinib+pegylated interferon alpha [ Time Frame: at least 18 months after start of study treatment ]rate of MMR 18 months after randomization for each study treatment
- rate of continuous MMR after discontinuation of nilotinib versus pegylated interferon alpha [ Time Frame: at least 12 months after stopping all therapy ]rate of patients with molecular relapse (loss of MMR) 12 months after discontinuation of any treatment for CML
- rate of CCyR and MMR [ Time Frame: at 12, 18 and 24 months after start of treatment ]
- Time to CCyR, MMR, MR4 and MR4.5 [ Time Frame: date of randomization until time to endpoints or end of study duration (at least 36 months) ]this time to-event endpoints give an impression of the velocity of drug response and of the time until a certain remission should be waited for
- rate of MR4 and MR4.5 during maintenance therapy and after discontinuation [ Time Frame: start of maintenance therapy (after at least 24 months of treatment) until end of study duration (at least 36 months) ]
- Progression-Free Survival (PFS) [ Time Frame: at 12, 24 and 60 months after start of treatment ]
- Rate of patients off treatment for at least 6 months [ Time Frame: at 60 months after start of treatment ]all patients and comparison of treatment arms
- safety and tolerability profile of nilotinib in comparison with nilotinib+pegylated interferon alpha and pegylated interferon alpha [ Time Frame: time of first study treatment until 28 days after stop of study treatment (expected 36 months) ]the time of risk is the time while receiving the therapy plus 28 days thereafter
- patients compliance to nilotinib based therapies [ Time Frame: until stop of study treatment (at least 36 months) ]
- quality of life during induction therapy with ilotinib versus nilotinib+pegylated interferon alpha and during maintenance therapy with nilotinib versus pegylated interferon alpha [ Time Frame: during induction therapy (until at least 24 months), during maintenance therapy (until at least 36 months) ]
- pharmacoeconomics of the treatment strategies [ Time Frame: after end of study (expected in December 2020) (up to 8 years) ]
- Overall Survival (OS) [ Time Frame: at 12, 24 and 60 months after start of treatment ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657604
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|Principal Investigator:||Andreas Hochhaus, Prof. MD||Jena University Hospital|