Acute Myeloid Leukemia Clinical Trial

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

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) 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.

View Eligibility Criteria

Eligibility 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 2
Adequate hepatic and renal function
White blood cell (WBC) count at randomization less than or equal to (
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 or for engraftment syndrome after autologous stem cell transplantation 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 except for malignancy that has been in remission without treatment for at least 2 years prior to randomization
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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

447

Study ID:

NCT02545283

Recruitment Status:

Terminated

Sponsor:

Hoffmann-La Roche

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There are 82 Locations for this study

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Northwell Health
Great Neck New York, 11021, United States
New York Medical College
Hawthorne New York, 10532, United States
Ichan School of Medicine at Mount Sinai
New York New York, 10029, United States
Abramson Cancer Center; Univ of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Baylor University Medical Center
Dallas Texas, 75204, United States
M.D. Anderson Cancer Center; Department of Hematology
Houston Texas, 77030, United States
Canberra Hospital; Haematology Department
Canberra Australian Capital Territory, 2605, Australia
Concord Repatriation General Hospital; Haematology
Sydney New South Wales, 2139, Australia
Royal Adelaide Hospital; Haematology Clinical Trials
Adelaide South Australia, 5000, Australia
Geelong Hospital; Andrew Love Cancer Centre
Geelong Victoria, 3220, Australia
Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation
Melbourne Victoria, 3004, Australia
Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
Graz , 8036, Austria
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul , 7100, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
AZ Delta (Campus Rumbeke)
Roeselare , 8800, Belgium
Juravinski Cancer Clinic; Clinical Trials Department
Hamilton Ontario, L8V 5, Canada
Helsinki University Central Hospital; Hematology
Helsinki , 00290, Finland
Tampere University Hospital; Hematology
Tampere , 33521, Finland
Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
Angers Cedex 9 , 49933, France
Hopital Claude Huriez; Hematologie
Lille , 59037, France
Institut J Paoli I Calmettes; Onco Hematologie 2
Marseille , 13273, France
Hopital Hotel Dieu Et Hme;Hopital De Jour
Nantes , 44093, France
Hopital Saint Louis; Oncologie Medicale
Paris , 75475, France
HOPITAL SAINT ANTOINE;Hematologie Clinique
Paris , 75571, France
Hopital De Haut Leveque; Hematologie Clinique
Pessac , 33604, France
Centre Hospitalier Lyon Sud; Hematolgie
Pierre Benite , 69495, France
IUCT Oncopole; Hematologie
Toulouse , 31059, France
Hopitaux De Brabois; Hematologie Medecine Interne
Vandoeuvre Les Nancy , 54511, France
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.
Aachen , 52074, Germany
Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie
Bonn , 53127, Germany
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
Braunschweig , 38114, Germany
Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III
Chemnitz , 09113, Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden , 01307, Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
Hannover , 30625, Germany
Klinik der Uni zu Köln; I. Med. Klinik
Köln , 50937, Germany
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
Mainz , 55131, Germany
Universitätsklinikum Marburg Zentrum f. Innere Medizin
Marburg , 35043, Germany
Shaare Zedek Medical Center; Hematology Dept.
Jerusalem , 91031, Israel
Hadassah Ein Karem Hospital; Haematology
Jerusalem , 91120, Israel
Rabin Medical Center-Beilinson Campus;Hematology-Oncology
Petach Tikva , 49414, Israel
Ichilov Sourasky Medical Center; Heamatology
Tel Aviv , 64239, Israel
Ospedale Cardarelli; Divisione Di Ematologia
Napoli Campania, 80131, Italy
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli
Bologna Emilia-Romagna, 40138, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia
Meldola Emilia-Romagna, 47014, Italy
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia
Ravenna Emilia-Romagna, 48100, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine Friuli-Venezia Giulia, 33100, Italy
Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
Roma Lazio, 00133, Italy
IRCCS AOU S.Martino; Clinica Ematologica
Genova Liguria, 16132, Italy
ASST PAPA GIOVANNI XXIII; Ematologia
Bergamo Lombardia, 24127, Italy
Ospedale San Raffaele, IRCCS
Milano Lombardia, 20132, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milano Lombardia, 20162, Italy
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
Orbassano (TO) Piemonte, 10043, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Torino Piemonte, 10126, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
Firenze Toscana, 50135, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa Toscana, 56100, Italy
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Seoul St Mary's Hospital
Seoul , 06591, Korea, Republic of
Academisch Medisch Centrum; Hematologie
Amsterdam , 1105 , Netherlands
Academisch Ziekenhuis Maastricht
Maastricht , 6202 , Netherlands
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland , 1023, New Zealand
Haukeland Universitetssjukehus; Klinisk forskningspost
Bergen , 5021, Norway
Oslo Universitetssykehus HF, Rikshospitalet
Oslo , 0372, Norway
Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología
Panama City , 0824, Panama
"Hematological Scientific Center
Moscow , 12516, Russian Federation
St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta
Saint-Petersburg , 19702, Russian Federation
FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health
Sankt-Petersburg , 19734, Russian Federation
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
Barcelona , 08025, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona , 08036, Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Hospital Universitario la Fe; Servicio de Hematologia
Valencia , 46026, Spain
Universitätsspital Basel; Hämatologie
Basel , 4031, Switzerland
Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie
Zürich , 8091, Switzerland
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
University Hospital of Wales
Cardiff , CF14 , United Kingdom
St Bartholomew's Hospital
London , EC1M , United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

447

Study ID:

NCT02545283

Recruitment Status:

Terminated

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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