ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission (ENDURE-CML-IX)

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ClinicalTrials.gov Identifier: NCT03117816

Recruitment Status : Recruiting

First Posted : April 18, 2017

Last Update Posted : May 21, 2019

See Contacts and Locations

Sponsor:

Collaborators:

Deutsche Krebshilfe e.V., Bonn (Germany)

AOP Orphan Pharmaceuticals AG

Information provided by (Responsible Party):

Kerstin Balthasar, Philipps University Marburg Medical Center

Study Description

Brief Summary:

A randomized, open-label assessor blinded, multi-center, controlled phase II Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).

Condition or disease	Intervention/treatment	Phase
Chronic Myeloid Leukemia in Remission	Drug: AOP2014 / Pegylated-Proline-interferon alpha-2b Other: Surveillance	Phase 2

Detailed Description:

Four hypotheses are tested in hierarchical order. To avoid inflation of type 1 error (false rejection of a null hypothesis), further confirmatory testing has to be stopped as soon as a null hypothesis could not be rejected.

All four hypotheses are tested at significance level 0.05. Null hypotheses 1, 2, and 4 deal with probabilities of molecular relapse-free survival 7, 13, and 25 months after randomisation, respectively; arms A and B are compared with the uncorrected chi-square test. Null hypothesis 3 investigates molecular relapse-free survival as a time-to-event variable; the two arms are compared with the log-rank test

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	214 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Masking Description:	A randomized, open-label assessor blinded, multi-center, controlled phase II trial
Primary Purpose:	Prevention
Official Title:	Efficacy and Safety of Pegylated Proline Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients With Chronic Myeloid Leukemia (CML) Who Discontinue ABL-Kinase Inhibitor Therapy - a Randomized Phase II, Multicenter Trial With Post-study Follow-up
Actual Study Start Date :	May 4, 2017
Estimated Primary Completion Date :	September 2021
Estimated Study Completion Date :	December 2024

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Chronic myeloid leukemia

MedlinePlus related topics: Chronic Myeloid Leukemia Leukemia

Drug Information available for: Proline Interferon Interferon Alfa-2b

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: investigational arm A There will be an overlapping treatment with AOP2014 and TKI for one month. After one month, the TKI therapy will be stopped and patient will receive only AOP2014 treatment for the next 14 months.	Drug: AOP2014 / Pegylated-Proline-interferon alpha-2b AOP2014 as pre-filled auto-injection pen for subcutaneous injection, containing 250 µg AOP2014 / 0.5 ml. The solution also contains inactive ingredients (sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, and acetic acid). The solution is colorless to light yellow.
surveillance arm B This is an open-label study with a "surveillance" group as comparator arm. Similar as in the arm A, patient will discontinue TKI therapy one month after randomization. From then on patient will receive no further CML treatment.	Other: Surveillance For patients randomized into this treatment arm stopp their standard treatment and will just be under observation.

Outcome Measures

Primary Outcome Measures :

RFS 7 [ Time Frame: 7 months after randomization ]
The primary efficacy endpoint is molecular relapse free survival, RFS 7 months after randomization. Relapse is defined as loss of major molecular remission, MMR, which is any increase of the BCR-ABL ratio to > 0.1% according to the international scale (IS). Time to relapse is defined as the time from randomization to relapse

Secondary Outcome Measures :

RFS 13 [ Time Frame: 13 months after randomization ]
The relapse free survival, RFS 13 months after randomization
RFS 25 [ Time Frame: 25 months after randomization ]
The relapse free survival, RFS 25 months after randomization
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Day 0 - Month 15 (Arm B) or Month 16 (additional safety visit one month after last application for Arm A) ]
Adverse events, serious adverse events (AEs, SAEs)• Safety, tolerability and toxicity based on incidences of adverse events, serious adverse events
Quality of life measured by EORTC QLQ-C30 [ Time Frame: Day 0 - Month 25 ]
The data will be compared between the treatment groups and to QoL of normal population.
Quality of life measured by EORTC-QLQ-CML24 [ Time Frame: Day 0 - Month 25 ]
The data will be compared between the treatment groups and to QoL of normal population. Furthermore, results of the CML24 module should be shared with the EORTC group to complete the validation of this questionnaire
detection of blood parameter 95 CD86+pDC as RFS predictor [ Time Frame: Day 0 - Month 15 ]
To validate the value of 95 CD86+pDC / 105 lymphocytes at baseline (before TKI stop) as a predictor of RFS
OS (overall survival) [ Time Frame: Day 0 - Month 25 (plus annual post study follow up Months 36,48,60) ]
Overall survival (OS), defined as the time between the date of randomization and the date of death from any cause.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed written informed consent form.
Capability and willingness to comply with study procedures and ability to self-administration of the study drug.
Male or female aged ≥ 18 years.
At least three years of TKI therapy.
BCR-ABL-positive, chronic phase CML patients with a transcript level according to the international scale (IS) of at least MR4, or better (MR4.5, MR5). MR4 is defined as (i) detectable disease ≤0.01% BCR-ABL IS or (ii) undetectable disease in cDNA with ≥10,000 ABL or ≥24,000 GUS transcripts for at least one year. There have to be at least three consecutive PCR-results with MR4 or better within the last year (+ months) before study entry. The latest of these PCRs must be a confirmatory MR4 measurement prior to randomization by the EUTOS-certified Study Reference Laboratories for PCR (BCR-ABL mRNA). No PCR-results in the last year before randomisation can be worse than MR4. If the last PCR was not done within two months from baseline (day 0) in an EUTOS-certified study Reference Laboratory; the PCR sample must be sent to an EUTOS-certified study Reference Laboratory at screening.
Patients who had failed to discontinue TKI in a prior discontinuation attempt are eligible for this protocol, if they fulfil criterion 5 after retreatment with TKI. A prior TKI discontinuation failure must be specifically indicated at inclusion and documented.
Adequate organ function:

especially total bilirubin, lactate dehydrogenase [LDH], aspartate aminotransferase [AST], alanine aminotransferase [ALT] and coagulation parameters ≤ 2 × upper limit of normal (ULN)
Adequate hematological parameters:

platelet count ≥ 100 × 1000000000/L; white blood cell count ≥ 2.5 × 1000000000/L; lymphocytes ≥ 1.0 × 1000000000/L; hemoglobin ≥ 9.0 g/dL or 5.59 mmol/L.
Female patients with reproductive potential must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used. Male patients must agree to use condoms during study participation.
Negative serum pregnancy test in women of childbearing potential.
Date of diagnosis of CML confirmed by laboratory PCR must be known.

Exclusion Criteria:

Rare variants of BCR-ABL not quantifiable by RT-PCR according to the international scale (IS).
Current or previous autoimmune diseases requiring treatment.
Immunosuppressive treatment of any kind; transplant recipients
Prior allogeneic stem cell transplantation.
Prior pegylated IFN therapy. Prior low dose conventional IFN treatment with ≤ 3 x 3 Mio I.E. / week for less than 1 year is acceptable.
History of TKI resistance within the last 4 years of TKI therapy.
History of accelerated phase or blast crisis.
Hypersensitivity/allergy to the active substance or excipients of the formulation.
Severe hepatic dysfunction or decompensated cirrhosis.
End stage renal disease (GFR <15 ml/min)
Thyroid disease that cannot be controlled by conventional therapy.
Uncontrolled diabetes mellitus
Epilepsy or other disorders of the central nervous system.
Severe cardiac disease history including unstable or uncontrolled cardiac disease in the previous 6 months.
Uncontrolled hypertension
Any history of retinopathy e.g. retinal detachment, degeneration or thromboembolic events.
Clinically significant concomitant diseases or conditions, which, in the opinion of the investigator, would lead to an unacceptable risk for the patient to participate in the study (please refer also to the actual Investigator Brochure).
Other malignancy, except adequately treated superficial bladder cancer, basal or squamous cell carcinoma of the skin, or other cancer(s) for which the patient has been disease free for more than 3 years.
Active or uncontrolled infections at the time of randomization.
Pregnant and/or nursing women.
Use of antibiotic therapy within the last 2 weeks prior to randomization
Concurrent use of molecular targeted therapy.
Tested HIV sero-positivity or tested active hepatitis B or C infection.
Participation in another clinical study with other investigational drugs within 14 days prior to randomization.
Vaccination within 1 month prior to randomization.
Any medical, mental, psychological or psychiatric condition (particularly severe depression, suicidal ideation or suicide attempt) that in the opinion of the investigator would not permit the patient to complete the study or comply to study procedures.
Drug and/or alcohol abuse.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117816

Contacts

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Contact: Andreas Burchert, Prof. Dr.	0049 6421 586 ext 5611	burchert@staff.uni-marburg.de
Contact: Kerstin Balthasar	0049 6421 286 ext 6558	kerstin.balthasar@kks.uni-marburg.de

Locations

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France
Institut Bergonié	Not yet recruiting
Bordeaux, France, 33076
Contact: Gabriel Etienne, MD +33 (0)5 5633 ext 0448 g.etienne@bordeaux.unicancer.fr
Centre Léon Bérard	Not yet recruiting
Lyon, France, 69373
Contact: Franck E. Nicolini, MD, PhD, HDR ++33 (0)4 7878 ext 2737 Franck-Emmanuel.NICOLINI@lyon.unicancer.fr
CHRU de Nancy - Hôpitaux de Brabois	Not yet recruiting
Vandœuvre-lès-Nancy, France, 54500
Contact: Agnès Guerci-Bresler, MD +33 (0)3 8315 ext 3282 a.guerci@chu-nancy.fr
Germany
Universitätsklinikum Aachen	Recruiting
Aachen, Germany, 52074
Contact: Martina Crysant, MD ++49 241 80 ext 80591 mcrysandt@ukaachen.de
Contact: Tim H. Brümmendorf, Prof ++49 241 80 ext 89805 tbruemmendorf@ukaachen.de
Principal Investigator: Martina Crysant, MD
Studienzentrum Aschaffenburg	Recruiting
Aschaffenburg, Germany, 63739
Contact: Martine Klausmann, MD ++49 6021-342 ext 780 mk@klausmann.de
Contact: Silke Schirrmacher-Memmel, MD ++49 6021-342 ext 780 sm@klausmann.de
Universitätsmedizin Berlin Charite- Campus Virchow Klinikum	Recruiting
Berlin, Germany, 13353
Contact: Philipp Le Courte, MD ++49 30 450 665 ext 307 philipp.lecoutre@charite.de
Contact: Theo Kim, MD ++49 30 450 ext 513077 theo.kim@charite.de
Principal Investigator: Philipp Le Courte, MD
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III	Recruiting
Bonn, Germany, 53105
Contact: Jai-Jün Shiue, MD ++49 228 287 17 ext 233 jai-juen.shiue@ukb.uni-bonn.de
Contact: Lino Teichmann, MD 0228-287 51 ext 630 lino.teichmann@ukb.uni-bonn.de
Klinikum Bremen Mitte, Medizinische Klinik I	Recruiting
Bremen, Germany, 28177
Contact: Matthias Bormann, Dr.med. ++49 421 497 ext 5132 matthias.bormann@klinikum-bremen-mitte.de
Contact: Bernd Hertenstein, Prof ++49 421 497 ext 5240 bernd.hertenstein@klinikum-bremen-mitte.de
BAG / Onkologische Gemeinschaftspraxis	Recruiting
Dresden, Germany, 01307
Contact: Thomas Illmer, PD Dr. ++49 351 44000 ext 22 illmer@onkologie-dresden.net
Contact: Jens Freiberg-Richter, Dr. med. ++49 351 44000 ext 22 freiberg-richter@onkologie-dresden.net
Universitätsklinikum Düsseldorf	Recruiting
Dusseldorf, Germany, 40225
Contact: Norbert Gattermann, Prof +49 211- 81 ext 16500 gattermann@med.uni-duesseldorf.de
Contact: Judith Strapatsas (née Neukirchen), MD +49 211- 81 ext 17720 judith.strapatsas@med.uni-duesseldorf.de
Principal Investigator: Norbert Gattermann, Prof
Universitätsklinikum Erlangen	Recruiting
Erlangen, Germany, 91054
Contact: Stefan Krause, Prof ++49 9131 85 ext 35957 stefan.krause@uk-erlangen.de
Contact: Norbert Meidenbauer, PD, MD ++49 9131 85 ext 36766 norbert.meidenbauer@uk-erlangen.de
Principal Investigator: Stefan Krause, Prof
Universitätsklinikum Essen, Klinik für Hämatologie	Recruiting
Essen, Germany, 45147
Contact: Joachim Goethert, MD ++49 201 723 84 ext 729 joachim.goethert@uk-essen.de
Contact: Maher Hanoun, MD 0201 723 83 ext 847 maher.hanoun@uk-essen.de
Klinikum der Goethe Universität, Medizinische Klinik II	Recruiting
Frankfurt a. Main, Germany, 60590
Contact: Fabian Lang, Dr.med. ++49 69 6301 ext 4013 fabian.lang@kgu.de
Contact: Jörg Chromik, Dr.med. ++49 69 6301 ext 6103 joerg.chromik@kgu.de
Universitätsklinikum Hamburg Eppendorf	Recruiting
Hamburg, Germany, 20246
Contact: Philippe Schafhausen, Dr. med. +49 40 7410 ext 57122 schafhausen@uke.de
Contact: Snjezana Janjetovic, Dr. med. +49 40 7410 ext 50661 s.janjetovic@uke.de
Evangelische Krankenhaus Hamm gGmbH	Recruiting
Hamm, Germany, 59063
Contact: Elisabeth Lange, MD 0049 2381 90583 ext 25 marianne.david@valeo-kliniken.de
Contact: Thomas Wehler, Prof. Dr. 0049 2381 589 ext 1863 onkologie.hamm@valeo-kliniken.de
Onkologische Praxis Heilbronn	Withdrawn
Heilbronn, Germany, 74072
Universitätsklinikum Jena	Recruiting
Jena, Germany, 07740
Contact: Andreas Hochhaus, Prof +49 3641 932 ext 4200 Andreas.Hochhaus@med.uni-jena.de
Contact: Thomas Schenk, MD +49 3641 939 ext 6661 thomas.schenk@med.uni-jena.de
Principal Investigator: Andreas Hochhaus, Prof
Institut für Versorgungsforschung in der Onkologie GbR	Recruiting
Koblenz, Germany, 56068
Contact: Christoph Lutz, MD 0261-9215 ext 6930 lutz@invo-koblenz.de
Contact: Rudolf Weide, Prof. Dr. med. 0261-9215 ext 6930 weide@invo-koblenz.de
Universitätsklinikum Leipzig	Recruiting
Leipzig, Germany, 04103
Contact: Georg-Nikolaus Franke, MD ++49 341 97 ext 13020 Georg-Nikolaus.Franke@medizin.uni-leipzig.de
Contact: Song-Yau Wang, MD ++49 341 97 ext 13030 song-yau.wang@medizin.uni-leipzig.de
Principal Investigator: Georg-Nikolaus Franke, MD
Johannes-Gutenberg-Universität III. Medizinische Klinik	Recruiting
Mainz, Germany, 55131
Contact: Thomas Kindler, PD, MD ++49 6131 17 ext 5046 thomas.kindler@unimedizin-mainz.de
Contact: Markus Radsak, Prof ++49 6131 17 ext 5947 radsak@uni-mainz.de
Principal Investigator: Thomas Kindler, PD, MD
Universitätsmedizin Mannheim	Recruiting
Mannheim, Germany, 68169
Contact: Susanne Saussele, PD, MD ++49 621-383 ext 6966 Susanne.Saussele@medma.uni-heidelberg.de
Contact: Henning Popp, MD ++49 621-383 ext 4115 henning.popp@medma.uni-heidelberg.de
Principal Investigator: Susanne Saussele, PD, MD
Universitätsklinikum Gießen und Marburg GmbH	Recruiting
Marburg, Germany, 35043
Contact: Andreas Burchert, Prof. +49 6421 586 ext 6511 burchert@staff.uni-marburg.de
Contact: Stephan K. Metzelder, MD +49 6421 586 ext 2724 metzelde@med.uni-marburg.de
Principal Investigator: Andreas Burchert, Prof.
Universitätsklinikum Münster	Recruiting
Muenster, Germany, 48149
Contact: Eva Esseling, MD ++49 251 83 ext 52807 eva.esseling@ukmuenster.de
Contact: Jan-Henrik Mikesch, MD ++49 251 83 ext 52818 Jan-Henrik.Mikesch@ukmuenster.de
Principal Investigator: Eva Schmidt, MD
III. Medizinischen Klinik TUM Klinikum rechts der Isar	Recruiting
Munich, Germany, 81675
Contact: Philipp Jost, PD, MD ++49 89 4140 ext 5941 philipp.jost@tum.de
Contact: Stefanie Jilg, MD ++49 89 4140 ext 4111 stefanie.jilg@tum.de
Principal Investigator: Philipp Jost, PD, MD
Universitätsklinikum Tübingen	Recruiting
Tubingen, Germany, 72076
Contact: Robert Möhle, Prof ++40 7071-29 ext 83179 robert.moehle@med.uni-tuebingen.de
Contact: Martin Sökler, MD ++40 7071-29 ext 80686 martin.soekler@med.uni-tuebingen.de
Principal Investigator: Robert Möhle, Prof
Universitätsklinikum Ulm	Recruiting
Ulm, Germany, 89081
Contact: Frank Stegelmann, MD ++49 731-500 ext 45521 frank.stegelmann@uniklinik-ulm.de
Contact: Konstanze Döhner, Prof ++49 731-500 ext 45505 konstanze.doehner@uniklinik-ulm.de
Principal Investigator: Frank Stegelmann, MD
Universitätsklinikum Würzburg, Zentrum für Innere Medizin	Recruiting
Würzburg, Germany, 97080
Contact: Maria-Elisabeth Goebeler, Dr.med. ++49 931 201 ext 40966 goebeler_m@ukw.de
Contact: Volker Kunzmann, Prof. Dr. med. ++49 931 201 ext 40004 kunzmann_v@ukw.de

Sponsors and Collaborators

Philipps University Marburg Medical Center

Deutsche Krebshilfe e.V., Bonn (Germany)

AOP Orphan Pharmaceuticals AG

Investigators

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Study Director:	Andreas Burchert, Prof. Dr.	Philipps University Marburg Medical Center
Principal Investigator:	Franck E Nicoloni, MD, PhD	Centre Léon Bérard Lyon

More Information

Publications:

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Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boqué C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Müller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saußele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM, Hehlmann R. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013 Aug 8;122(6):872-84. doi: 10.1182/blood-2013-05-501569. Epub 2013 Jun 26. Review.

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Müller MC, Cross NC, Erben P, Schenk T, Hanfstein B, Ernst T, Hehlmann R, Branford S, Saglio G, Hochhaus A. Harmonization of molecular monitoring of CML therapy in Europe. Leukemia. 2009 Nov;23(11):1957-63. doi: 10.1038/leu.2009.168. Epub 2009 Aug 27. Review.

Hehlmann R, Müller MC, Lauseker M, Hanfstein B, Fabarius A, Schreiber A, Proetel U, Pletsch N, Pfirrmann M, Haferlach C, Schnittger S, Einsele H, Dengler J, Falge C, Kanz L, Neubauer A, Kneba M, Stegelmann F, Pfreundschuh M, Waller CF, Spiekermann K, Baerlocher GM, Ehninger G, Heim D, Heimpel H, Nerl C, Krause SW, Hossfeld DK, Kolb HJ, Hasford J, Saußele S, Hochhaus A. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-study IV. J Clin Oncol. 2014 Feb 10;32(5):415-23. doi: 10.1200/JCO.2013.49.9020. Epub 2013 Dec 2.

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Corbin AS, Agarwal A, Loriaux M, Cortes J, Deininger MW, Druker BJ. Human chronic myeloid leukemia stem cells are insensitive to imatinib despite inhibition of BCR-ABL activity. J Clin Invest. 2011 Jan;121(1):396-409. doi: 10.1172/JCI35721. Epub 2010 Dec 13. Erratum in: J Clin Invest. 2011 Mar 1;121(3):1222.

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Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F, Legros L, Charbonnier A, Guerci A, Varet B, Etienne G, Reiffers J, Rousselot P; Intergroupe Français des Leucémies Myéloïdes Chroniques. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010 Nov;11(11):1029-35. doi: 10.1016/S1470-2045(10)70233-3. Epub 2010 Oct 19.

Ross DM, Branford S, Seymour JF, Schwarer AP, Arthur C, Yeung DT, Dang P, Goyne JM, Slader C, Filshie RJ, Mills AK, Melo JV, White DL, Grigg AP, Hughes TP. Safety and efficacy of imatinib cessation for CML patients with stable undetectable minimal residual disease: results from the TWISTER study. Blood. 2013 Jul 25;122(4):515-22. doi: 10.1182/blood-2013-02-483750. Epub 2013 May 23.

Rousselot P, Charbonnier A, Cony-Makhoul P, Agape P, Nicolini FE, Varet B, Gardembas M, Etienne G, Réa D, Roy L, Escoffre-Barbe M, Guerci-Bresler A, Tulliez M, Prost S, Spentchian M, Cayuela JM, Reiffers J, Chomel JC, Turhan A, Guilhot J, Guilhot F, Mahon FX. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol. 2014 Feb 10;32(5):424-30. doi: 10.1200/JCO.2012.48.5797. Epub 2013 Dec 9.

Branford S, Yeung DT, Ross DM, Prime JA, Field CR, Altamura HK, Yeoman AL, Georgievski J, Jamison BA, Phillis S, Sullivan B, Briggs NE, Hertzberg M, Seymour JF, Reynolds J, Hughes TP. Early molecular response and female sex strongly predict stable undetectable BCR-ABL1, the criteria for imatinib discontinuation in patients with CML. Blood. 2013 May 9;121(19):3818-24. doi: 10.1182/blood-2012-10-462291. Epub 2013 Mar 20.

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Layout table for additonal information

Responsible Party:	Kerstin Balthasar, KKS Marburg Sponsor representative, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:	NCT03117816 History of Changes
Other Study ID Numbers:	KKS-227 2016-001030-94 ( EudraCT Number )
First Posted:	April 18, 2017 Key Record Dates
Last Update Posted:	May 21, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Kerstin Balthasar, Philipps University Marburg Medical Center:


deep molecular remission of MR4 or better

Additional relevant MeSH terms:

Layout table for MeSH terms

Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases	Interferons Interferon-alpha Interferon alpha-2 Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs

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