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Feasibility of treatment free remission with generic imatinib: Results of GIFT-in-CML-CP study
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  • Deepak Goni ,
  • Arihant Jain,
  • Nishant Jindal ,
  • Ram Nampoothiri,
  • Deepesh Lad,
  • Shano Naseem,
  • Gaurav Prakash,
  • Alka Khadwal,
  • Neelam Varma,
  • Pankaj Malhotra
Deepak Goni
PGIMER
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Arihant Jain
PGIMER
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Nishant Jindal
PGIMER
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Ram Nampoothiri
PGIMER
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Deepesh Lad
PGIMER
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Shano Naseem
PGIMER
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Gaurav Prakash
PGIMER
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Alka Khadwal
PGIMER
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Neelam Varma
PGIMER
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Pankaj Malhotra
PGIMER
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Abstract

Both innovator and generic imatinib are approved for the treatment of Chronic Myeloid Leukemia-Chronic phase (CML-CP). Currently, there are no studies on the feasibility of treatment free remission (TFR) with generic imatinib. In a single center prospective Generic Imatinib Free Trial - in -CML-CP (GIFT-in-CML-CP) study, twenty-six patients on generic imatinib for more than 3 years and in sustained deep molecular response (BCR ABLIS <0.01% for more than 2 years) were included. After treatment discontinuation, patients were monitored with complete blood count and BCR ABLIS by real time quantitative PCR monthly for one year and three monthly thereafter. Generic imatinib was restarted at single documented loss of major molecular response. At a median follow-up of 20 months (range, 4-34 months), 42.3% patients (n=11) continued to be in TFR. Estimated TFR at 1 year was 44%. All patients restarted on generic imatinib regained major molecular response. On multivariate analysis, attainment of complete molecular remission (CMR) prior to TFR trial was predictive of TFR [p=0.022, HR 0.284 (0.096-0.837)]. We conclude that , generic imatinib can be safely discontinued in CML-CP patients who are in deep molecular remission.