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A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (MIRROS)

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ClinicalTrials.gov Identifier: NCT02545283
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS), leukemia-free survival (LFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Cytarabine Drug: Idasanutlin Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Actual Study Start Date : December 30, 2015
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : May 26, 2021


Arm Intervention/treatment
Experimental: Idasanutlin plus Cytarabine
Participants will receive induction therapy idasanutlin and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.
Drug: Cytarabine
Participants will receive cytarabine 1 gram per square meter (g/m^2) intravenous (IV) infusion for 5 days of every treatment cycle.

Drug: Idasanutlin
Participants will receive idasanutlin 300 mg per oral (PO) twice daily (BID) (in Cycle 1) or once daily (QD) (in Cycles 2 and 3) for 5 days of every treatment cycle.

Placebo Comparator: Placebo plus Cytarabine
Participants will receive induction therapy idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.
Drug: Cytarabine
Participants will receive cytarabine 1 gram per square meter (g/m^2) intravenous (IV) infusion for 5 days of every treatment cycle.

Other: Placebo
Participants will receive idasanutlin matching placebo PO BID or QD for 5 days of every treatment cycle.




Primary Outcome Measures :
  1. Overall Survival in TP53 WT Population [ Time Frame: Baseline up to approximately 3.5 years ]

Secondary Outcome Measures :
  1. Overall Survival in the Overall Population [ Time Frame: Baseline up to approximately 3.5 years ]
  2. Percentage of Participants in CR at the End of Induction According to Hematologic Malignancy Response Assessment (HMRA) in TP53 WT Population [ Time Frame: At the end of induction (up to Day 56) ]
  3. Percentage of Participants in CRp at the End of Induction According to HMRA in TP53 WT Population [ Time Frame: At the end of induction (up to Day 56) ]
  4. Percentage of Participants with Overall Remission at the End of Induction According to HMRA in TP53 WT Population [ Time Frame: At the end of induction (up to Day 56) ]
  5. EFS According to HMRA in TP53 WT Population [ Time Frame: Baseline up to treatment failure, relapse or death from any cause (up to approximately 3.5 years) ]
  6. LFS According to HMRA in TP53 WT Population [ Time Frame: Date of remission to date of relapse or death (up to approximately 3.5 years) ]
  7. Percentage of Participants Undergoing HSCT Following Response, in TP53 WT Population [ Time Frame: Baseline up to approximately 3.5 years ]
  8. Percentage of Participants in CR at the End of Induction According to HMRA in Overall Population [ Time Frame: At the end of induction (up to Day 56) ]
  9. Percentage of Participants in CRp at the End of Induction According to HMRA in Overall Population [ Time Frame: At the end of induction (up to Day 56) ]
  10. Percentage of Participants with Overall Remission at the End of Infusion According to HMRA in Overall Population [ Time Frame: At the end of induction (up to Day 56) ]
  11. EFS According to HMRA in Overall Population [ Time Frame: Baseline up to treatment failure, relapse or death from any cause (up to approximately 3.5 years) ]
  12. LFS According to HMRA in Overall Population [ Time Frame: Date of remission to date of relapse or death (up to approximately 3.5 years) ]
  13. Percentage of Participants Undergoing HSCT Following Response, in Overall Population [ Time Frame: Baseline up to approximately 3.5 years ]
  14. Apparent Clearance (CL/F) of Idasanutlin [ Time Frame: Cycle 1: Predose (0 hour [Hr]), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) ]
  15. Apparent Volume of Distribution (Vd/F) of Idasanutlin [ Time Frame: Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) ]
  16. Maximum Concentration Observed (Cmax) of Idasanutlin [ Time Frame: Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) ]
  17. Steady-State Concentration (C trough) of Idasanutlin [ Time Frame: Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) ]
  18. Area Under the Concentration-Time Curve (AUC) During One Dosing Interval (AUCtau) of Idasanutlin [ Time Frame: Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) ]
  19. AUC from Time Zero to 24 Hours Post Dose (AUC0-24) of Idasanutlin [ Time Frame: Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) ]
  20. Half-Life (t 1/2) of Idasanutlin [ Time Frame: Cycle 1: Predose (0 Hr), end of 1-3 Hr cytarabine infusion, 6 Hr postdose on Days 1, 5; Predose (0 Hr) on Day 2; at Days 8, 10; Cycle 2, 3: predose (0 Hr) on Days 2, 5 (predose/postdose: relative to idasanutlin morning dose; cycle length= 28 days) ]
  21. Total Clearance (CL) of Cytarabine [ Time Frame: Cycle 1: Within 2 Hr pre-cytarabine dose, end of 1-3 Hr cytarabine infusion, 6 Hr post idasanutlin morning dose on Days 1, 5; Within 2 Hr pre-cytarabine dose on Day 2; Cycle 2, 3: Within 2 Hr pre-cytarabine dose on Day 2 (Cycle length= 28 days) ]
  22. Volume of Distribution (Vd) of Cytarabine [ Time Frame: Cycle 1: Within 2 Hr pre-cytarabine dose, end of 1-3 Hr cytarabine infusion, 6 Hr post idasanutlin morning dose on Days 1, 5; Within 2 Hr pre-cytarabine dose on Day 2; Cycle 2, 3: Within 2 Hr pre-cytarabine dose on Day 2 (Cycle length= 28 days) ]
  23. Percentage of Participants with Adverse Events [ Time Frame: Baseline up to approximately 3.5 years ]
  24. Change from Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score [ Time Frame: Cycle 1 Day 1 (Baseline), Days 8, 15, 28 of Cycle 1, Days 1, 8, 15, 28 of Cycles 2, 3, 28 days after last dose (last dose on Cycle 3 Day 5), thereafter every 3 months until relapse (maximum up to 3.5 years) ]
  25. Change from Baseline in EuroQol 5 Dimension 5-Level (EQ-5D-5L) Questionnaire Score [ Time Frame: Cycle 1 Day 1 (Baseline), Days 8, 15, 28 of Cycle 1, Days 1, 8, 15, 28 of Cycles 2, 3, 28 days after last dose (last dose on Cycle 3 Day 5), thereafter every 3 months until relapse (maximum up to 3.5 years) ]


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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:

  • Documented/confirmed first/second refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
  • No more than 2 prior induction regimens (excluding prior HSCT) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione)
  • Eastern Cooperative Oncology Group performance status of 0 to 1
  • Adequate hepatic and renal function
  • White blood cell (WBC) count at randomization less than or equal to (</=) 50000 cells per cubic millimeter (/mm^3)

Exclusion Criteria:

  • First relapsed participants aged less than (<) 60 years with first CR duration greater than (>) 1 year
  • Participants with prior documented antecedent hematological disorder (AHD)
  • AML secondary to any prior chemotherapy unrelated to leukemia
  • Participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (>/=) 18 g/m^2 of cytarabine
  • Participants who have received allogeneic HSCT within 90 days prior to randomization
  • Participants who have received immunosuppressive therapy for graft versus host disease within 2 weeks prior to randomization
  • Prior treatment with an Murine Double Minute 2 (MDM2) antagonist
  • Participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug
  • Participants with a history of other malignancy within 5 years prior to screening
  • Participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Participants with extramedullary AML with no evidence of systemic involvement
  • Pregnant or breastfeeding participants

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): NCT02545283


Contacts
Contact: Reference Study ID Number: WO29519 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Hide Study Locations
Locations
United States, New York
Northwell Health Recruiting
Great Neck, New York, United States, 11021
New York Medical College Not yet recruiting
Hawthorne, New York, United States, 10532
Ichan School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, Pennsylvania
Abramson Cancer Center; Univ of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75204
M.D. Anderson Cancer Center; Department of Hematology Recruiting
Houston, Texas, United States, 77030
Baylor Scott & White Health Not yet recruiting
Temple, Texas, United States, 76502
United States, Wisconsin
Aurora Research Institute Not yet recruiting
Wauwatosa, Wisconsin, United States, 53226
Australia, Australian Capital Territory
Canberra Hospital; Haematology Department Recruiting
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Concord Repatriation General Hospital; Haematology Recruiting
Sydney, New South Wales, Australia, 2139
Australia, South Australia
Royal Adelaide Hospital; Haematology Clinical Trials Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Geelong Hospital; Andrew Love Cancer Centre Recruiting
Geelong, Victoria, Australia, 3220
Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation Recruiting
Melbourne, Victoria, Australia, 3004
Austria
Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie Recruiting
Graz, Austria, 8036
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. Terminated
Salzburg, Austria, 5020
Belgium
CH Jolimont - Lobbes (Jolimont) Recruiting
Haine-Saint-Paul, Belgium, 7100
UZ Leuven Gasthuisberg Terminated
Leuven, Belgium, 3000
CHU Sart-Tilman Recruiting
Liège, Belgium, 4000
AZ Delta (Campus Wilgenstraat) Active, not recruiting
Roeselare, Belgium, 8800
Canada, Manitoba
Cancer Care Manitoba Terminated
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Clinic; Clinical Trials Department Completed
Hamilton, Ontario, Canada, L8V 5C2
Ottawa General Hospital Withdrawn
Ottawa, Ontario, Canada, K1H 8L6
Finland
Helsinki University Central Hospital; Hematology Recruiting
Helsinki, Finland, 00290
Tampere University Hospital; Hematology Recruiting
Tampere, Finland, 33521
France
Centre Hospitalier Uni Ire; Service Des Maladies Du Sang Active, not recruiting
Angers Cedex 9, France, 49933
Hopital Claude Huriez; Hematologie Recruiting
Lille, France, 59037
Institut J Paoli I Calmettes; Onco Hematologie 2 Active, not recruiting
Marseille, France, 13273
Hopital Hotel Dieu Et Hme;Hopital De Jour Recruiting
Nantes, France, 44093
Hopital Saint Louis; Oncologie Medicale Recruiting
Paris, France, 75475
HOPITAL SAINT ANTOINE;Hematologie Clinique Recruiting
Paris, France, 75571
Hopital De Haut Leveque; Hematologie Clinique Recruiting
Pessac, France, 33604
Centre Hospitalier Lyon Sud; Hematolgie Recruiting
Pierre Benite, France, 69495
IUCT Oncopole; Hematologie Recruiting
Toulouse, France, 31059
Hopitaux De Brabois; Hematologie Medecine Interne Recruiting
Vandoeuvre Les Nancy, France, 54511
Germany
Uniklinik RWTH Aachen; Med. Klinik IV; Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammz Recruiting
Aachen, Germany, 52074
Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie Terminated
Bonn, Germany, 53127
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie Active, not recruiting
Braunschweig, Germany, 38114
Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III Recruiting
Chemnitz, Germany, 09113
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I Recruiting
Dresden, Germany, 01307
Universitätsklinikum Hamburg-Eppendorf; Med. II. Klinik Terminated
Hamburg, Germany, 20246
Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie Active, not recruiting
Hannover, Germany, 30625
Klinik der Uni zu Köln; I. Med. Klinik Recruiting
Köln, Germany, 50937
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik Active, not recruiting
Mainz, Germany, 55131
Universitätsklinikum Marburg Zentrum f. Innere Medizin Active, not recruiting
Marburg, Germany, 35043
Israel
Soroka Medical Center; Hematology Deptartment Terminated
Beer Sheva, Israel, 8410101
Shaare Zedek Medical Center; Hematology Dept. Recruiting
Jerusalem, Israel, 9103102
Hadassah Ein Karem Hospital; Haematology Recruiting
Jerusalem, Israel, 9112001
Rabin Medical Center-Beilinson Campus;Hematology-Oncology Recruiting
Petach Tikva, Israel, 4941492
Sheba Medical Center Terminated
Ramat Gan, Israel, 5262100
Ichilov Sourasky Medical Center; Heamatology Recruiting
Tel Aviv, Israel, 6423906
Assuta Medical Centre, Hematology; Hematology Terminated
Tel Aviv, Israel, 6971028
Italy
Azienda Ospedaliera di Catanzaro; Ematologia, Oncologia e Medicina Trasfusionale Recruiting
Catanzaro, Calabria, Italy, 88100
Ospedale Cardarelli; Divisione Di Ematologia Completed
Napoli, Campania, Italy, 80131
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia Recruiting
Meldola, Emilia-Romagna, Italy, 47014
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia Recruiting
Ravenna, Emilia-Romagna, Italy, 48100
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica Recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia Recruiting
Roma, Lazio, Italy, 00133
IRCCS AOU S.Martino; Clinica Ematologica Recruiting
Genova, Liguria, Italy, 16132
ASST PAPA GIOVANNI XXIII; Ematologia Recruiting
Bergamo, Lombardia, Italy, 24127
Ospedale San Raffaele, IRCCS Recruiting
Milano, Lombardia, Italy, 20132
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia Recruiting
Milano, Lombardia, Italy, 20162
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone Recruiting
Orbassano (TO), Piemonte, Italy, 10043
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia Recruiting
Torino, Piemonte, Italy, 10126
Ospedale Businco; Ematologia Terminated
Cagliari, Sardegna, Italy, 09121
AO Ospedali Riuniti Villa Sofia-Cervello-Presidio Ospedaliero Cervello; Dip. Ematologia e Oncologia Terminated
Palermo, Sicilia, Italy, 90146
Az. Osp. Di Careggi; Divisione Di Ematologia Recruiting
Firenze, Toscana, Italy, 50135
Ospedale Santa Chiara; Unita Operativa Di Ematologia Recruiting
Pisa, Toscana, Italy, 56100
Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Chonnam National University Hwasun Hospital Recruiting
Jeollanam-do, Korea, Republic of, 58128
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System; Pharmacy Recruiting
Seoul, Korea, Republic of, 03722
Seoul St Mary's Hospital Completed
Seoul, Korea, Republic of, 06591
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 6351
Netherlands
Academisch Medisch Centrum; Hematologie Active, not recruiting
Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Maastricht Completed
Maastricht, Netherlands, 6202 AZ
New Zealand
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service Recruiting
Auckland, New Zealand, 1023
Canterbury Health Laboratories; Haematology Terminated
Christchurch, New Zealand, 8011
Norway
Haukeland Universitetssjukehus; Klinisk forskningspost Recruiting
Bergen, Norway, 5021
Oslo Universitetssykehus HF, Rikshospitalet Recruiting
Oslo, Norway, 0372
Panama
Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología Recruiting
Panama City, Panama, 0824
Russian Federation
Kirov State Inst. of Hematology & Blood Transfusion Recruiting
Kirov, Russian Federation, 610027
"Hematological Scientific Center Recruiting
Moscow, Russian Federation, 125167
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta Recruiting
Saint-Petersburg, Russian Federation, 197022
FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health Recruiting
Sankt-Petersburg, Russian Federation, 197341
Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia Recruiting
Barcelona, Spain, 08025
Hospital Universitari Vall d'Hebron; Servicio de Hematologia Terminated
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología Recruiting
Barcelona, Spain, 08036
Hospital Univ. 12 de Octubre; Servicio de Hematologia Recruiting
Madrid, Spain, 28041
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Universitario la Fe; Servicio de Hematologia Recruiting
Valencia, Spain, 46026
Switzerland
Universitätsspital Basel; Hämatologie Recruiting
Basel, Switzerland, 4031
Inselspital Bern; Universitätsklinik für medizinische Onkologie Withdrawn
Bern, Switzerland, 3010
Universitätsspital Zürich; Klinik für Hämatologie Active, not recruiting
Zürich, Switzerland, 8091
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Christie Hospital NHS Trust Recruiting
Manchester, United Kingdom, M20 4BX
Nottingham City Hospital; Oncology Withdrawn
Nottingham, United Kingdom, NG5 1PB
Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02545283     History of Changes
Other Study ID Numbers: WO29519
2014-003065-15 ( EudraCT Number )
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs