Chronic Myeloid Leukemia in Myeloid Blast CrisisPhase 2NICE-BORANCT01690065
Nilotinib-Chemotherapy in CML Myeloid BP or Bcr-abl(+) AML
A Phase 2 study testing Nilotinib+AD induction in people with Chronic Myeloid Leukemia in Myeloid Blast Crisis and Untreated Adult Acute Myeloid Leukemia, run by Ulsan University Hospital at 2 sites in South Korea.
Trial summary
The current standard therapy in previously untreated adults with chronic phase (CP) of CML is imatinib and the result of long-term follow-up of IRIS study proves that imatinib for CML CP is reasonable therapy.(1, 2) However, some patients were initially diagnosed as advanced CML, accelerated phase (AP) or blastic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Myeloid Leukemia in Myeloid Blast Crisis, Untreated Adult Acute Myeloid Leukemia
- What is being tested?
- Nilotinib+AD induction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2012to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously-untreated patients having bcr-abl gene rearrangement (or t(9;22)) and 20% or more of myeloid blasts in bone marrow and/or blood, or converted CML CP/AP to MBP after initial imatinib treatment.
- 15 years old or older, but 65 years or younger
- Adequate performance status (Karnofsky score of 50 or more)
- Adequate hepatic and renal function (AST, ALT, bilirubin and creatinine < 2.5 x upper normal limit). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.
- Adequate cardiac function (left ventricular ejection fraction of 45% or more on heart scan or echocardiogram)
- Signed and dated informed consent must be obtained.
Who cannot join
- Patients without bcr-abl gene rearrangement
- Acute lymphoblastic leukemia with bcr-abl gene rearrangement or t(9;22)
- Any previous history of TKIs except for imatinib in CML CP.
- Therapy-related leukemia or leukemia after myelodysplastic syndrome.
- Patients with CNS leukemia
- Patients with primary granulocytic sarcoma without bone marrow involvement
Show all 20Show fewer
- Prior chemotherapy for leukemia or anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
- Presence of significant active infection
- Presence of uncontrolled bleeding
- Significant cardiovascular disease including myocardial infarction within previous 6 months
- Cardiac dysfunction: LVEF < 45% or institutional lower normal range (any higher value of them) by echocardiogram or MUGA scan; Long QT syndrome or its family history; Clinically significant resting bradycardia (<50 beats/minute); QTc > 450 msec (by QTcF formula) on baseline ECG . If QTcF > 450 msec and electrolytes are abnormal, retest QTc after the correction of electrolytes; Myocardial infarction within 12 months; Other clinically significant cardiac diseases (for example, unstable angina, congestive heart failure, uncontrolled hypertension or uncontrolled arrhythmia)
- Chronic or acute hepatic disease, pancreatic disease or severe renal disease
- Severe or life-threatening other medical conditions
- Any coexisting major illness or organ failure
- Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible History of congenital or acquired coagulopathy unrelated to malignancy
- Pregnancy issues: (a) pregnant woman, (b) lactating woman, (c) reproductive woman who does not confirm negative baseline pregnancy test (d) man or reproductive woman who cannot continue an appropriate contraceptive method (postmenopausal woman who has no menstruation for last 12 months is considered as non-reproductive)
- Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
- History of non-compliance or patient who cannot sign informed consent
- Hypersensitivity to nilotinib or any of the experience
- Concurrent medications (Gastrointestinal dysfunction that can significantly change the absorption of test drug; - Strong CYP3A4 inhibitor and cannot stop or change the medication before starting study; Medication to prolong QT interval and cannot stop or change the medication before starting study) • The capsules contain lactose, and nilotinib is therefore not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul St Mary's Hospital
Seoul
Dong-Wook Kim, M.D., Ph.D., dwkim@catholic.ac.kr
Dong-Wook Kim, M.D., Ph.D.
- Recruiting
Ulsan University Hospital
Ulsan, 682714
Hawk Kim, M.D., Ph.D.
Jae-Hoo Park, M.D., Ph.D.
About this study
Official title: Nilotinib Combined by Chemotherapy for Myeloid Blastic Phase of Chronic Myeloid Leukemia or Bcr-abl Positive Acute Myeloid Leukemia
The current standard therapy in previously untreated adults with chronic phase (CP) of CML is imatinib and the result of long-term follow-up of IRIS study proves that imatinib for CML CP is reasonable therapy.(1, 2) However, some patients were initially diagnosed as advanced CML, accelerated phase (AP) or blastic phase (BP). Various chemotherapies were tried and were found that there were no highly effective chemotherapies for CML BP.(3-11) Imatinib in patients with these advanced CML is also disappointing because of low response rates as well as short response duration, and sudden transformation to BC is found even in initial CML CP patients. (12-17). Recent studies showed that nilotinib or dasatinib is better than imatinib in terms of rapid response and higher molecular response in newly diagnosed CML patients.(18-21) More potent bcr-abl suppression of nilotinib is supposed to be more active than imatinib even in patients with advanced CML. However, nilotinib in patients with imatinib-resistant or -intolerant CML BP showed low hematologic response and major cytogenetic response.(22, 23)
Read the detailed description
- 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.
- Being tested
- Nilotinib+AD induction
- Keywords
- chronic myeloid leukemia, myeloid blastic phase, bcr-abl(+) acute myeloid leukemia, nilotinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nilotinib+AD inductionDrug
Also called Tasigna
- Post-remission consolidation chemotherapy
- 4 courses of high-dose cytarabine will be given as post-remission therapy. Cytarabine 3 g/m2 will be administered in a 3-hour iv infusion every 12 hours on days 1, 3, and 5 (a total of six doses per course).
- Nilotinib 400mg bid PO will be administered continuously during consolidation chemotherapy and for 2 years after the consolidation therapy or until allogeneic hematopoietic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Nilotinib+AD induction | Experimental | Nilotinib plus AD induction chemotherapy
* AD regimen : Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Daunorubicin 90 mg/m2/day iv daily for 3 days (D 1-3)
* Nilotinib 400mg bid PO (continuous without interruption from D8 of induction chemotherapy)
* Re-induction chemotherapy AD regimen : Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 5 days (D 1-5) plus Daunorubicin 45 mg/m2/day iv daily for 2 days (D 1-2) Receives: Drug: Nilotinib+AD induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
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.
Measured: Within 8 weeks after induction therapy
Secondary outcomes (2)
Safety
- This study will also evaluate the safety of nilotinib and chemotherapy combination therapy.
- CTCAE ver. 4.03 will be used for safety measurement.
Measured: Within 8 weeks after induction therapy
Time-dependent variables
- 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).
Measured: at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid Leukemia in Myeloid Blast CrisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Korean Society of Hematology CML working party
- Responsible party
- Principal investigator, Hawk Kim, Ulsan University Hospital
- Investigators
- Hawk Kim, M.D., Ph.D., Principal investigator, Ulsan University Hospital, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690065
- Sponsor's protocol ID
- CAMN107AKR07T
- Acronym
- NICE-BORA
- Status last verified
- May 2016
- First submitted
- 11 Sep 2012
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ; IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004. doi: 10.1056/NEJMoa022457.
PubMed 12637609Hochhaus A, O'Brien SG, Guilhot F, Druker BJ, Branford S, Foroni L, Goldman JM, Muller MC, Radich JP, Rudoltz M, Mone M, Gathmann I, Hughes TP, Larson RA; IRIS Investigators. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61. doi: 10.1038/leu.2009.38. Epub 2009 Mar 12.
PubMed 19282833Bauduer F, Delmer A, Blanc MC, Delmas-Marsalet B, Cadiou M, Rio B, Marie JP, Zittoun R. Treatment of chronic myelogenous leukemia in blast crisis and in accelerated phase with high- or intermediate-dose cytosine arabinoside and amsacrine. Leuk Lymphoma. 1993 Jun;10(3):195-200. doi: 10.3109/10428199309145883.
PubMed 8220118Coleman M, Silver RT, Pajak TF, Cavalli F, Rai KR, Kostinas JE, Glidewell O, Holland JF. Combination chemotherapy for terminal-phase chronic granulocytic leukemia: cancer and leukemia group B studies. Blood. 1980 Jan;55(1):29-36.
PubMed 6927956Dutcher JP, Eudey L, Wiernik PH, Paietta E, Bennett JM, Arlin Z, Kellermeyer R, Rowe J, O'Connell M, Oken M, et al. Phase II study of mitoxantrone and 5-azacytidine for accelerated and blast crisis of chronic myelogenous leukemia: a study of the Eastern Cooperative Oncology Group. Leukemia. 1992 Aug;6(8):770-5.
PubMed 1379312Dutcher JP, Lee S, Paietta E, Bennett JM, Stewart JA, Wiernik PH. Phase II study of carboplatin in blast crisis of chronic myeloid leukemia: Eastern Cooperative Oncology Group Study E1992. Leukemia. 1998 Jul;12(7):1037-40. doi: 10.1038/sj.leu.2401056.
PubMed 9665187Feldman EJ, Alberts DS, Arlin Z, Ahmed T, Mittelman A, Baskind P, Peng YM, Baier M, Plezia P. Phase I clinical and pharmacokinetic evaluation of high-dose mitoxantrone in combination with cytarabine in patients with acute leukemia. J Clin Oncol. 1993 Oct;11(10):2002-9. doi: 10.1200/JCO.1993.11.10.2002.
PubMed 8410125Giles FJ, Feldman EJ, Roboz GJ, Larson RA, Mamus SW, Cortes JE, Verstovsek S, Faderl S, Talpaz M, Beran M, Albitar M, O'Brien SM, Kantarjian HM. Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with untreated or imatinib mesylate-resistant chronic myelogenous leukemia in blastic phase. Leuk Res. 2003 Dec;27(12):1091-6. doi: 10.1016/s0145-2126(03)00094-8.
PubMed 12921945Kantarjian HM, O'Brien S, Cortes J, Giles FJ, Faderl S, Issa JP, Garcia-Manero G, Rios MB, Shan J, Andreeff M, Keating M, Talpaz M. Results of decitabine (5-aza-2'deoxycytidine) therapy in 130 patients with chronic myelogenous leukemia. Cancer. 2003 Aug 1;98(3):522-8. doi: 10.1002/cncr.11543.
PubMed 12879469Koller CA, Miller DM. Preliminary observations on the therapy of the myeloid blast phase of chronic granulocytic leukemia with plicamycin and hydroxyurea. N Engl J Med. 1986 Dec 4;315(23):1433-8. doi: 10.1056/NEJM198612043152301.
PubMed 2431313O'Brien S, Kantarjian H, Keating M, Beran M, Koller C, Robertson LE, Hester J, Rios MB, Andreeff M, Talpaz M. Homoharringtonine therapy induces responses in patients with chronic myelogenous leukemia in late chronic phase. Blood. 1995 Nov 1;86(9):3322-6.
PubMed 7579434Jabbour E, Kantarjian H, O'Brien S, Rios MB, Abruzzo L, Verstovsek S, Garcia-Manero G, Cortes J. Sudden blastic transformation in patients with chronic myeloid leukemia treated with imatinib mesylate. Blood. 2006 Jan 15;107(2):480-2. doi: 10.1182/blood-2005-05-1816. Epub 2005 Sep 29.
PubMed 16195326Kantarjian HM, Cortes J, O'Brien S, Giles FJ, Albitar M, Rios MB, Shan J, Faderl S, Garcia-Manero G, Thomas DA, Resta D, Talpaz M. Imatinib mesylate (STI571) therapy for Philadelphia chromosome-positive chronic myelogenous leukemia in blast phase. Blood. 2002 May 15;99(10):3547-53. doi: 10.1182/blood.v99.10.3547.
PubMed 11986206Morimoto A, Ogami A, Chiyonobu T, Takanashi M, Sugimoto T, Imamura T, Ishida H, Yoshihara T, Imashuku S. Early blastic transformation following complete cytogenetic response in a pediatric chronic myeloid leukemia patient treated with imatinib mesylate. J Pediatr Hematol Oncol. 2004 May;26(5):320-2. doi: 10.1097/00043426-200405000-00013.
PubMed 15111787Pavlu J, Czepulkowski B, Kaczmarski R, Jan-Mohamed R. Early blastic transformation with CNS infiltration in a patient with chronic myeloid leukaemia treated with imatinib. Lancet Oncol. 2005 Feb;6(2):128. doi: 10.1016/S1470-2045(05)01744-4. No abstract available.
PubMed 15683824
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nilotinib Combined by Chemotherapy for Myeloid Blastic Phase of Chronic Myeloid Leukemia or Bcr-abl Positive Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT01690065
- Acronym / sponsor ID
- NICE-BORA / CAMN107AKR07T
- Keywords
- chronic myeloid leukemia, myeloid blastic phase, bcr-abl(+) acute myeloid leukemia, nilotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Collaborators
- The Korean Society of Hematology CML working party
- Study start
- Sep 2012
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard therapy in previously untreated adults with chronic phase (CP) of CML is imatinib and the result of long-term follow-up of IRIS study proves that imatinib for CML CP is reasonable therapy.(1, 2) However, some patients were initially diagnosed as advanced CML, accelerated phase (AP) or blastic phase (BP). Various chemotherapies were tried and were found that there were no highly effective chemotherapies for CML BP.(3-11) Imatinib in patients with these advanced CML is also disappointing because of low response rates as well as short response duration, and sudden transformation to BC is found even in initial CML CP patients. (12-17). Recent studies showed that nilotinib or dasatinib is better than imatinib in terms of rapid response and higher molecular response in newly diagnosed CML patients.(18-21) More potent bcr-abl suppression of nilotinib is supposed to be more active than imatinib even in patients with advanced CML. However, nilotinib in patients with imatinib-resistant or -intolerant CML BP showed low hematologic response and major cytogenetic response.(22, 23)
Detailed description
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nilotinib+AD induction | Experimental | Drug: Nilotinib+AD inductionNilotinib plus AD induction chemotherapy * AD regimen : Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Daunorubicin 90 mg/m2/day iv daily for 3 days (D 1-3) * Nilotinib 400mg bid PO (continuous without interruption from D8 of induction chemotherapy) * Re-induction chemotherapy AD regimen : Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 5 days (D 1-5) plus Daunorubicin 45 mg/m2/day iv daily for 2 days (D 1-2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with previously-untreated patients having bcr-abl gene rearrangement (or t(9;22)) and 20% or more of myeloid blasts in bone marrow and/or blood, or converted CML CP/AP to MBP after initial imatinib treatment.
- 15 years old or older, but 65 years or younger
- Adequate performance status (Karnofsky score of 50 or more)
- Adequate hepatic and renal function (AST, ALT, bilirubin and creatinine < 2.5 x upper normal limit). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.
- Adequate cardiac function (left ventricular ejection fraction of 45% or more on heart scan or echocardiogram)
Key exclusion criteria (20 listed)
- Patients without bcr-abl gene rearrangement
- Acute lymphoblastic leukemia with bcr-abl gene rearrangement or t(9;22)
- Any previous history of TKIs except for imatinib in CML CP.
- Therapy-related leukemia or leukemia after myelodysplastic syndrome.
- Patients with CNS leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nilotinib+AD inductionAlso: Tasigna• Post-remission consolidation chemotherapy * 4 courses of high-dose cytarabine will be given as post-remission therapy. Cytarabine 3 g/m2 will be administered in a 3-hour iv infusion every 12 hours on days 1, 3, and 5 (a total of six doses per course). * Nilotinib 400mg bid PO will be administered continuously during consolidation chemotherapy and for 2 years after the consolidation therapy or until allogeneic hematopoietic stem cell transplantation | Drug | Nilotinib+AD induction |
Primary outcome
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.
2 secondary outcomes
Safety
Time frame: Within 8 weeks after induction therapy
Time-dependent variables
Time frame: at least 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 12637609O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ; IRIS Investigators. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004. doi: 10.1056/NEJMoa022457.
- Background: PubMed 19282833Hochhaus A, O'Brien SG, Guilhot F, Druker BJ, Branford S, Foroni L, Goldman JM, Muller MC, Radich JP, Rudoltz M, Mone M, Gathmann I, Hughes TP, Larson RA; IRIS Investigators. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009 Jun;23(6):1054-61. doi: 10.1038/leu.2009.38. Epub 2009 Mar 12.
- Background: PubMed 8220118Bauduer F, Delmer A, Blanc MC, Delmas-Marsalet B, Cadiou M, Rio B, Marie JP, Zittoun R. Treatment of chronic myelogenous leukemia in blast crisis and in accelerated phase with high- or intermediate-dose cytosine arabinoside and amsacrine. Leuk Lymphoma. 1993 Jun;10(3):195-200. doi: 10.3109/10428199309145883.
- Background: PubMed 6927956Coleman M, Silver RT, Pajak TF, Cavalli F, Rai KR, Kostinas JE, Glidewell O, Holland JF. Combination chemotherapy for terminal-phase chronic granulocytic leukemia: cancer and leukemia group B studies. Blood. 1980 Jan;55(1):29-36.
- Background: PubMed 1379312Dutcher JP, Eudey L, Wiernik PH, Paietta E, Bennett JM, Arlin Z, Kellermeyer R, Rowe J, O'Connell M, Oken M, et al. Phase II study of mitoxantrone and 5-azacytidine for accelerated and blast crisis of chronic myelogenous leukemia: a study of the Eastern Cooperative Oncology Group. Leukemia. 1992 Aug;6(8):770-5.
- Background: PubMed 9665187Dutcher JP, Lee S, Paietta E, Bennett JM, Stewart JA, Wiernik PH. Phase II study of carboplatin in blast crisis of chronic myeloid leukemia: Eastern Cooperative Oncology Group Study E1992. Leukemia. 1998 Jul;12(7):1037-40. doi: 10.1038/sj.leu.2401056.
- Background: PubMed 8410125Feldman EJ, Alberts DS, Arlin Z, Ahmed T, Mittelman A, Baskind P, Peng YM, Baier M, Plezia P. Phase I clinical and pharmacokinetic evaluation of high-dose mitoxantrone in combination with cytarabine in patients with acute leukemia. J Clin Oncol. 1993 Oct;11(10):2002-9. doi: 10.1200/JCO.1993.11.10.2002.
- Background: PubMed 12921945Giles FJ, Feldman EJ, Roboz GJ, Larson RA, Mamus SW, Cortes JE, Verstovsek S, Faderl S, Talpaz M, Beran M, Albitar M, O'Brien SM, Kantarjian HM. Phase II study of troxacitabine, a novel dioxolane nucleoside analog, in patients with untreated or imatinib mesylate-resistant chronic myelogenous leukemia in blastic phase. Leuk Res. 2003 Dec;27(12):1091-6. doi: 10.1016/s0145-2126(03)00094-8.
- Background: PubMed 12879469Kantarjian HM, O'Brien S, Cortes J, Giles FJ, Faderl S, Issa JP, Garcia-Manero G, Rios MB, Shan J, Andreeff M, Keating M, Talpaz M. Results of decitabine (5-aza-2'deoxycytidine) therapy in 130 patients with chronic myelogenous leukemia. Cancer. 2003 Aug 1;98(3):522-8. doi: 10.1002/cncr.11543.
- Background: PubMed 2431313Koller CA, Miller DM. Preliminary observations on the therapy of the myeloid blast phase of chronic granulocytic leukemia with plicamycin and hydroxyurea. N Engl J Med. 1986 Dec 4;315(23):1433-8. doi: 10.1056/NEJM198612043152301.
- Background: PubMed 7579434O'Brien S, Kantarjian H, Keating M, Beran M, Koller C, Robertson LE, Hester J, Rios MB, Andreeff M, Talpaz M. Homoharringtonine therapy induces responses in patients with chronic myelogenous leukemia in late chronic phase. Blood. 1995 Nov 1;86(9):3322-6.
- Background: PubMed 16195326Jabbour E, Kantarjian H, O'Brien S, Rios MB, Abruzzo L, Verstovsek S, Garcia-Manero G, Cortes J. Sudden blastic transformation in patients with chronic myeloid leukemia treated with imatinib mesylate. Blood. 2006 Jan 15;107(2):480-2. doi: 10.1182/blood-2005-05-1816. Epub 2005 Sep 29.
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Myelofibrosis, MPN - Accelerated or Blast Phase
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Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
Acute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hawk Kim, M.D., Ph.D. principal investigator
Ulsan University Hospital, University of Ulsan College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nilotinib+AD induction in people with Chronic Myeloid Leukemia in Myeloid Blast Crisis and Untreated Adult Acute Myeloid Leukemia, run by Ulsan University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hawk Kim, M.D., Ph.D. (+82-52-250-8892, kimhawkmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: Within 8 weeks after induction therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01690065, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.