Nilotinib-Chemotherapy in CML Myeloid BP or Bcr-abl(+) AML (NICE-BORA)
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|ClinicalTrials.gov Identifier: NCT01690065|
Recruitment Status : Recruiting
First Posted : September 21, 2012
Last Update Posted : May 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia in Myeloid Blast Crisis Untreated Adult Acute Myeloid Leukemia||Drug: Nilotinib+AD induction||Phase 2|
- IMATINIB COMBINED WITH CHEMOTHERAPY FOR PHYLADELPHIA POSITIVE ACUTE LYMPHOBLASTIC LYMPHOMA (PH+ ALL) The trials combining imatinib with high-dose chemotherapy were successfully resulting in high response rate and longer survival and a role for bridging therapy to allogeneic hematopoietic stem cell transplantation (alloHSCT) by means of concurrent or alternating regimen in patients with Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL).(24-29) Current combination therapy of imatinib and chemotherapy became standard therapy of Ph+ ALL and new 2nd generation TKIs are investigating. These experiences may be translated into the treatment of CML BP.
- HIGH-DOSE DAUNORUBICIN IN ACUTE MYELOID LEUKEMIA (AML) INDUCTION CHEMOTHERAPY Two recently published papers of randomized trials comparing standard dose daunorubicin (45 mg/m2 for 3 days) and high dose daunorubicin (90 mg/m2 for 3 days) demonstrated improved CR rate and survival with high dose daunorubicin in younger (60 years or younger) and older (over 60 years) patients, respectively.(30, 31) Therefore high-dose daunorubicin can be applied safely and effectively to the treatment of CML BP.
- NILOTINIB COMBINED WITH CHEMOTHERAPY FOR PHYLADELPHIA POSITIVE CML MYELOID BLASTIC PHASE (MBP) OR PHYLADELPHIA POSITIVE AML We will try 2nd generation TKI, nilotinib and high-dose daunorubicin induction chemotherapy combination to find out the combination therapy can improve response rate and survival in patients with CML MBP.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nilotinib Combined by Chemotherapy for Myeloid Blastic Phase of Chronic Myeloid Leukemia or Bcr-abl Positive Acute Myeloid Leukemia|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Nilotinib+AD induction
Nilotinib plus AD induction chemotherapy
Drug: Nilotinib+AD induction
• Post-remission consolidation chemotherapy
Other Name: Tasigna
- Complete remission rate [ Time Frame: Within 8 weeks after induction therapy ]Primary purpose of this study is to define the efficacy of combined chemotherapy and nilotinib in chronic myeloid leukemia (CML) myeloid blastic phase (MBP) and bcr-abl positive acute myeloid leukemia (AML). The efficacy will be evaluated by complete remission (CR) rate.
- Safety [ Time Frame: Within 8 weeks after induction therapy ]
- This study will also evaluate the safety of nilotinib and chemotherapy combination therapy.
- CTCAE ver. 4.03 will be used for safety measurement.
- Time-dependent variables [ Time Frame: at least 2 years ]• This study will evaluate the impacts of nilotinib combined with chemotherapy on duration of CR, relapse-free survival (RFS), event-free survival (EFS), and overall survival (OS).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690065
|Contact: Hawk Kim, M.D., Ph.D.||+email@example.com|
|Contact: Min Jung Kim, R.N.||+firstname.lastname@example.org|
|Korea, Republic of|
|Seoul St Mary's Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Dong-Wook Kim, M.D., Ph.D. email@example.com|
|Principal Investigator: Dong-Wook Kim, M.D., Ph.D.|
|Ulsan University Hospital||Recruiting|
|Ulsan, Korea, Republic of, 682714|
|Principal Investigator: Hawk Kim, M.D., Ph.D.|
|Sub-Investigator: Jae-Hoo Park, M.D., Ph.D.|
|Sub-Investigator: Jae-Cheol Jo, M.D., Ph.D.|
|Principal Investigator:||Hawk Kim, M.D., Ph.D.||Ulsan University Hospital, University of Ulsan College of Medicine|