Clinical trial NCT02775903: An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
Official title: A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Keywords: MEDI4736
Durvalumab
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Hematopoietic Stem Cell Transplantation
Azacitidine
Safety
Efficacy
PD-L1
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.


Eligibility criteria: Inclusion Criteria:

For both cohorts:

1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
3. Female subjects of childbearing potential may participate, providing they meet the following conditions:

   1. Have 2 negative pregnancy tests as verified by the Investigator prior to starting any investigational product (IP) therapy: serum pregnancy test at screening and negative serum or urine pregnancy test (Investigator's discretion) within 72 hours prior to starting treatment with IP (Cycle 1, Day 1). They must agree to ongoing pregnancy testing during the course of the study (before beginning each subsequent cycle of treatment), and after the last dose of any IP. This applies even if the subject practices complete abstinence from heterosexual contact.
   2. Agree to practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to the use of a highly effective method of contraception use from 28 days prior to starting durvalumab or azacitidine, and must agree to continue using such precautions while taking durvalumab or azacitidine (including dose interruptions) and up to 90 days after the last dose of durvalumab or azacitidine. Cessation of contraception after this point should be discussed with a responsible physician.
   3. Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of IP.
   4. Refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.
4. Male subject must:

   1. Either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to avoid fathering a child, to use highly effective methods of contraception, male condom plus spermicide during sexual contact with a pregnant female or a female of childbearing potential (even if he has undergone a successful vasectomy) from starting dose of IP (Cycle 1 Day 1), including dose interruptions through 90 days after receipt of the last dose of durvalumab or azacitidine.
   2. Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP.
5. Understand and voluntarily sign a biomarker-specific component of the informed consent form prior to any study-related procedures conducted.
6. Willing and able to adhere to the study visit schedule and other protocol requirements.

   MDS Cohort:
7. Age ≥ 18 years at the time of signing the informed consent form.
8. Central confirmation of diagnosis of previously untreated primary or secondary myelodysplastic syndromes (MDS) as per World Health Organization (WHO) classification. Results of central pathology review are required prior to receiving the first dose of IP.
9. Central confirmation of the categorization of the MDS risk classification, as per the Revised - International prognostic scoring system (IPSS-R) Intermediate risk with \>10% blasts or poor or very poor cytogenetics, or IPSS-R High or Very High risk (results of central pathology review required prior to receiving the first dose of IP).

   Acute myeloid leukemia (AML) Cohort:
10. Age ≥ 65 years at the time of signing the informed consent form (ICF).
11. Central confirmation of diagnosis of one of the following untreated AML as per WHO classification:

    * Newly diagnosed, histologically confirmed de novo AML (bone marrow blasts ≥ 20%), or
    * AML secondary to prior MDS, or
    * AML secondary to exposure to potentially leukemogenic therapies or agents (eg, radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years.
12. Central confirmation of intermediate or poor risk status, based on Cytogenetics for acute myeloid leukemia.

Exclusion Criteria:

For both cohorts:

1. Prior hematopoietic stem cell transplant.
2. Considered eligible for hematopoietic stem cell transplant (allogeneic or autologous) at the time of signing the ICF.
3. Prior exposure to azacitidine, decitabine or prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative.
4. Inaspirable bone marrow.
5. Use of any of the following within 28 days prior to the first dose of IP:

   * Thrombopoiesis-stimulating agents (eg, romiplostim, eltrombopag, Interleukin-11)
   * Any hematopoietic growth factors (erythropoietin-stimulating agents \[ESAs\], granulocyte colony-stimulating factor (G-CSF) and other red blood cell (RBC) hematopoietic growth factors (eg, Interleukin-3)
   * Any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment
6. Prior history of malignancies (except MDS for AML subjects), unless the subject has been free of the disease for ≥ 2 years. However, subjects with the following history/concurrent conditions are allowed:

   * Basal or squamous cell carcinoma of the skin
   * Carcinoma in situ of the cervix
   * Carcinoma in situ of the breast
   * Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \[tumor, node, metastases (TNM)\] clinical staging system).
7. Pregnant or breast-feeding females or females who intend to become pregnant during study participation.
8. Subject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, Crohn's disease\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease \[exclude only if active within the last 6 months prior to signing the ICF\], or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:

   * Subjects with vitiligo or alopecia;
   * Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement for ≥ 3 months prior to signing the ICF; or
   * Subjects with psoriasis not requiring systemic treatment
9. Significant active cardiac disease within the previous 6 months prior to signing the ICF, including:

   * New York Heart Association (NYHA) Class III or IV congestive heart failure;
   * Unstable angina or angina requiring surgical or medical intervention; and/or
   * Significant cardiac arrhythmia
   * Myocardial infarction
10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment), uncontrolled hypertension, cardiac arrhythmia, pneumonitis, interstitial lung disease, active peptic ulcer disease or gastritis that would limit compliance with study requirement.
11. Known human immunodeficiency virus (HIV) or hepatitis C (HCV) infection, or evidence of active hepatitis B virus (HBV) infection.
12. Known or suspected hypersensitivity to azacitidine, mannitol, or durvalumab, its constituents, or to any other humanized monoclonal antibody.
13. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
14. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
15. Prior anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), programmed death-1 (PD-1), or programmed death ligand-1 (PD-L1) or other immune checkpoint mAb exposure.
16. Other investigational monoclonal antibodies (mAbs) within 6 months prior to first dose of IP.
17. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:

    * Intranasal, inhaled, topical, or local steroid injections (eg, intra-articular injection)
    * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
    * Steroids as premedication for hypersensitivity reactions (eg, computed tomography \[CT\] scan premedication)
18. History of primary immunodeficiency.
19. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and for 30 days after the last dose of durvalumab).
20. Unwilling or unable to complete subject reported outcome assessments without assistance or with minimal assistance from trained site personnel and/or caregiver.
21. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.
22. Presence of advanced malignant hepatic tumors.
23. Any of the following laboratory abnormalities:

    * Serum aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \> 2.5 × upper limit of normal (ULN)
    * Serum total bilirubin \> 1.5 × ULN. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of \> 2% with either a positive Coombs' test or over 50% of indirect bilirubin
    * Serum creatinine \> 2.5 × ULN.

    MDS Cohort:
24. Any previous cytotoxic, cytostatic, hormonal, biological or immunological treatment for MDS (ESA with or without G-CSF are allowed under certain conditions, see exclusion criterion # 5).
25. Any investigational therapy within 28 days prior to the first dose of IP.
26. Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
27. Absolute white blood cell (WBC) count ≥ 15 × 10\^9/L.

    AML Cohort:
28. Previous cytotoxic, cytostatic, hormonal, biological or immunological treatment (ESA with or without G-CSF and iron chelating therapy and hydroxyurea are allowed under certain conditions, see exclusion criterion #5) or biologic treatment for AML.
29. Any investigational therapy within 28 days prior to the first dose of IP.
30. Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
31. Prior use of targeted therapy agents (eg, FLT3 inhibitors, other kinase inhibitors).
32. Suspected or proven acute promyelocytic leukemia (French-American-British (FAB) M3) based on morphology, immunophenotype, molecular assay, or karyotype; AML associated with t(9;22) karyotype, biphenotypic acute leukemia or AML with previous hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms.
33. Acute myeloid leukemia associated with inv(16), t(8;21), t(16;16), t(15;17) karyotypes or molecular evidence of such translocations if not associated with a c-Kit mutation.
34. Absolute WBC count ≥ 15 × 10\^⁹/L (NOTE: Hydroxyurea is not allowed to attain a WBC count ≤ 15 x 10⁹/L).
35. Known history or presence of Sweet Syndrome at screening

Primary outcomes:
measure: MDS Cohort: Overall Response Rate
timeFrame: Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 239 days (AZA) and 215 days (DUR) in the AZA + DUR group and 210 days in the AZA alone group.
measure: AML Cohort: Overall Response Rate
timeFrame: Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 198 days (AZA) and 171 days (DUR) in the AZA + DUR group and 203 days in the AZA alone group.
Secondary outcomes:
measure: MDS Cohort: Kaplan Meier Estimate of Time to First Response
timeFrame: From randomization to the earliest date any response (up to approximately 34 months)
measure: MDS Cohort: Kaplan Meier Estimate of Relapse-free Survival
timeFrame: From randomization to to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months)
measure: MDS Cohort: Percentage of Participants Who Achieved a Cytogenetic Response
timeFrame: From randomization up to approximately 34 months
measure: MDS Cohort: Kaplan-Meier Estimate of Progression-free Survival (PFS)
timeFrame: From randomization to the first documented progressive disease (PD), relapse, or death due to any cause (up to approximately 34 months)
measure: MDS Cohort: Kaplan-Meier Estimate of Duration of Response
timeFrame: From randomization to the first overall response, or death (up to approximately 34 months)
measure: MDS Cohort: Kaplan-Meier Estimate of Time to AML Transformation
timeFrame: From randomization to the date the participant had documented transformation to AML (up to approximately 34 months)
measure: MDS Cohort: Percentage of Participants With Disease Transformation to AML
timeFrame: From randomization until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial (up to approximately 34 months)
measure: AML Cohort: Kaplan Meier Estimate of Time to First Response
timeFrame: From randomization and the earliest date any response (up to approximately 34 months)
measure: AML Cohort: Kaplan Meier Estimate of Relapse-free Survival
timeFrame: From randomization to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months)
measure: AML Cohort: Percentage of Participants Who Achieved a Complete Cytogenetic Response
timeFrame: From randomization up to approximately 34 months)
measure: AML Cohort: Percentage of Participants With Hematologic Improvement
timeFrame: From randomization up to approximately 34 months
measure: AML Cohort: Kaplan-Meier Estimate of Duration of Response
timeFrame: From randomization until relapse, PD, or death (up to approximately 34 months)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine proir to the extension study (up to approximately 34 months)
measure: Kaplan-Meier Estimate of Overall Survival
timeFrame: From randomization to date of death or last known alive date (up to approximately 34 months)
measure: One-year Survival
timeFrame: At 12 months after randomization
measure: Durvalumab Serum Concentration
timeFrame: Cycle 1 Day 1 end of infusion (EOI), Cycle 2 Day 1 pre-infusion, Cycle 4 Day 1 pre-infusion and EOI, and Cycle 6 Day 1 pre-infusion
measure: Change From Baseline in Selected Hematology Parameters I
timeFrame: Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)
measure: Change From Baseline in Selected Hematology Parameters II
timeFrame: Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)
measure: Change From Baseline in Selected Chemistry Parameters I
timeFrame: Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)
measure: Change From Baseline in Selected Chemistry Parameters II
timeFrame: Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)
measure: Change From Baseline in Selected Chemistry Parameters III
timeFrame: Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)
measure: Change From Baseline in Selected Chemistry Parameters IV
timeFrame: Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas- MD Anderson
state: Texas
city: Graz
country: Austria
facility: Medizinische Universitat Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck
city: Linz
country: Austria
facility: Elisabethinen Hospital Linz
city: Salzburg
country: Austria
facility: Salzburger Landkliniken St. Johanns-Spital
city: Wein
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Hanusch Krankenhaus der Stadt Wien
city: Wien
country: Austria
facility: Local Institution - 653
city: Brussels
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi
city: Gent
country: Belgium
facility: Local Institution - 202
city: Gent
country: Belgium
facility: UH Gent
city: Leuven
country: Belgium
facility: UH Gasthuisberg
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godine
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Notre Dame
state: Quebec
city: Angers
country: France
facility: Centre Hospitalier Universitaire d' Angers
city: Bobigny Cedex
country: France
facility: Hopital Avicenne
city: Creteil
country: France
facility: Hopital Henri Mondor
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Local Institution - 261
city: Nantes
country: France
facility: CHRU de Nantes - Hotel Dieu
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Local Institution - 251
city: Pessac
country: France
facility: CHU Bordeaux
city: Pessac
country: France
facility: Local Institution - 254
city: Pierre-Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Toulouse
country: France
facility: IUCT Oncopole
city: Dresden
country: Germany
facility: Local Institution - 604
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus
city: Dusseldorf
country: Germany
facility: Local Institution - 603
city: Dusseldorf
country: Germany
facility: Marien Hospital
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universitat
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hannover
country: Germany
facility: Medizinische Hochschule HannoverZentrum Innere Medizin
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Munchen
country: Germany
facility: Klinikum der LMU Campus Grosshadern
city: Munchen
country: Germany
facility: Local Institution - 605
city: Munchen
country: Germany
facility: Klinikum rechts der Isar der TU Munchen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Brecia
country: Italy
facility: AO Spedali Civili di Brescia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milano
country: Italy
facility: Ospedale Niguarda Milano
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
city: Pavia
country: Italy
facility: I.R.C.C.S. Policlinico San Matteo - Universita di Pavia
city: Pavia
country: Italy
facility: Local Institution - 302
city: Roma
country: Italy
facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli
city: Roma
country: Italy
facility: Local Institution - 303
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli - Istituto di Ematologia
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
city: Rome
country: Italy
facility: Local Institution - 304
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine
city: Varese
country: Italy
facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Brzozow
country: Poland
facility: Oddzial Hematologii Onkologicznej Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologicz
city: Gdansk
country: Poland
facility: Katedra i Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne
city: Lubin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku
city: Olsztyn
country: Poland
facility: Oddzial Hematologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW
city: Wroclaw
country: Poland
facility: Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra
city: Lisbon
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE
city: Porto
country: Portugal
facility: Ipo Instituto Portugues De Oncologia Porto
city: Porto
country: Portugal
facility: Local Institution - 502
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D hebron
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Caceres
country: Spain
facility: Complejo Hospitalario San Pedro de Alcantara
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: Local Institution - 555
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valencia
country: Spain
facility: Local Institution - 559
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: London Bloomsbury
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: St Bartholomews Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Oxford
country: United Kingdom
facility: Local Institution - 453
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Celgene Corporation
name: CL Beach, Pharm D
role: STUDY_DIRECTOR
References:
citation: Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Ogasawara K, Cavenagh J, Silverman LR, Voso MT, Hellmann A, Tormo M, O'Connor T, Previtali A, Rose S, Garcia-Manero G. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes. Blood Adv. 2022 Apr 12;6(7):2207-2218. doi: 10.1182/bloodadvances.2021005487.
citation: Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Hellmann A, Taussig DC, Tormo M, Voso MT, Cavenagh J, O'Connor T, Previtali A, Rose S, Silverman LR. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML. Blood Adv. 2022 Apr 12;6(7):2219-2229. doi: 10.1182/bloodadvances.2021006138.