Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations
NCT ID: NCT02272478
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
1600 participants
INTERVENTIONAL
2014-10-30
2022-02-28
Brief Summary
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At entry, a randomisation will compare a standard chemotherapy schedule DA (Daunorubicin/Ara-C) combined with 1 dose of Mylotarg (gemtuzumab ozogamicin, or GO) in course 1 against CPX-351. Patients who have known adverse risk cytogenetics (using Grimwade 2010 classification favourable/intermediate/adverse) at diagnosis may enter a Phase 2 evaluation of the combination of Vosaroxin plus Decitabine. Patients who achieve complete remission (CR) and who are MRD negative by flow cytometry after course one of DA will receive one further course of DA, with a randomisation to receive, either a course of DA or intermediate dose Cytarabine (IDAC) as a third course. Patients who are MRD negative by flow cytometry after course one of CPX-351 will receive up to 2 further course of CPX. Patients who fail to achieve a CR after course 1 of DA or who are MRD positive by flow cytometry or for whom MRD information is not available, are eligible to be randomised to compare DA with DA plus Cladribine (DAC) or FLAG-Ida for up to two courses of therapy. Patients who fail to achieve a CR after course 1 of CPX-351 or who are MRD positive by flow cytometry or for whom MRD information is not available are eligible to be randomised between a second course of standard dose CPX versus a repeat of the course 1 schedule. Patients receiving Vosaroxin and Decitabine are excluded from these post course 1 randomisations .
Following the outcome of course 1, patients who received DA chemotherapy on course 1 will be randomised to receive further chemotherapy with the 2nd generation FLT3 inhibitor AC220. Patients randomised to AC220 will be allocated a maximum of 3 courses (short AC220) or 3 courses plus maintenance for 1 year (long AC220). Patients receiving Vosaroxin and Decitabine are excluded from this randomisation.
Patients will be eligible for a non-intensive allogeneic stem cell transplant if a suitable HLA matched donor is available.
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Detailed Description
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There are five randomised comparisons within the trial:
1. At diagnosis:
For patients not known to have adverse risk cytogenetics DA chemotherapy plus a single dose of 3 mg/m2 of Mylotarg versus CPX-351. Patients with abnormal LFTs can enter the randomisation but receive DA alone or CPX-351.
2. For patients who received DA chemotherapy but are not in CR or who are MRD +ve, or for whom MRD is not assessable.
DA versus DAC versus FLAG-Ida
3. All patients at second course who have received DA and have not received Vosaroxin and Decitabine induction AC220 versus no AC220 for a maximum of 3 cycles; then with or without maintenance for 1 year for patients allocated AC220
4. For patients who are in CR or CRi and MRD -ve post course1 and have completed 2 courses of DA DA versus intermediate dose Cytarabine (IDAC)
5. For patients who received CPX-351 chemotherapy but are not in CR or who are MRD +ve, or for whom MRD is not assessable CPX-351 100 units/m2 x 3 doses versus CPX-351 100 units/m2 x 2 doses
The trial will also assess:
* Non-intensive allogeneic stem cell transplant for patients with matched sibling or matched unrelated donors.
* The combination of Vosaroxin and Decitabine for those with known adverse risk cytogenetics at diagnosis
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Arm A
Patients not known adverse karyotype
Randomise between
Daunorubicin 60mg/m2 daily by i.v. infusion on days 1, 3 and 5 (3 doses) Cytosine Arabinoside 100mg/m2 12 hourly by i.v. push on days 1 - 10 inclusive (20 doses) Mylotarg (GO) 3mg/m2 on day 1 of DA chemotherapy
Versus
CPX-351 100 units/m2 on days 1, 3 and 5
Arm A Mylotarg plus DA Versus CPX-351
Patients not known to have adverse risk cytogenetics will enter a randomisation comparing DA with Mylotarg (GO) delivered at 3mg/m2 on day 1 of chemotherapy, with CPX-351 on days 1, 3 and 5.
Arm B
Patients with known adverse karyotype
5 cycles of Vosaroxin and Decitabine therapy
Arm B Vosaroxin and Decitabine
If a patient is known to have adverse risk Cytogenetics at diagnosis they will enter a registration to receive up to 5 courses of Vosaroxin and Decitabine.
Arm C
Prior to Course 2 - Patients receving DA plus GO in course 1 and MRD positive PC1
Randomise between
Daunorubicin 50mg/2 daily by i.v. infusion on days 1, 3 and 5 (3 doses) Cytosine Arabinoside 100mg/m2 12 hourly by i.v.push on days 1 - 8 inclusive (16 doses)
Versus
Daunorubicin 50mg/m2 daily by i.v. infusion on days 1, 3 and 5 Cytosine Arabinoside 100mg/m2 12 hourly by i.v. push on days 1 - 8 inclusive Cladribine 5mg/m2 daily on days 1 - 5 inclusive
Versus Patients aged 60-69 Fludarabine 30mg/m2 daily on i.v. on days 2 - 6 inclusive Cytosine Arabinoside 1g/m2 daily over 4 hours Fludarabine on days 2 - 6 inclusive
Patients aged 70+ Fludarabine 25mg/m2 daily i.v. on days 2 - 5 inclusive Cytosine Arabinoside 1g/m2 daily over 4 hours Fludarabine on days 2 - 5 inclusive Idarubicin 5mg/m2 i.v. daily on days 3, 4 and 5 (3 doses)
And Randomisation to receive AC220 or not
Arm D Small molecule or Not
The randomisation to AC220 or not will take place immediately before course 2 of treatment for patients who have received DA induction +/- Mylotarg, irrespective of residual disease status. Patients allocated to receive AC220 will be randomised in a 1:1 fashion to AC220 or no small molecule with a 1:1 randomisation in patients drawing AC220 between short and long therapy.
Arm C DA V FLAG-Ida V DAC
If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1:1 fashion between DA, FLAG-Ida (or mini FLAG-Ida if 70 years or older) and DAC.
Arm D
Prior to Course 2 - Patients that received DA plus GO in course 1 and MRD negative PC1
Randomisation to receive AC220 or not
Arm D Small molecule or Not
The randomisation to AC220 or not will take place immediately before course 2 of treatment for patients who have received DA induction +/- Mylotarg, irrespective of residual disease status. Patients allocated to receive AC220 will be randomised in a 1:1 fashion to AC220 or no small molecule with a 1:1 randomisation in patients drawing AC220 between short and long therapy.
Arm E
Prior to Course 2 for patients receiving CPX in course 1 and MRD positive PC1
Randomisation between
CPX-351 100 units/m2 on days 1, and 3 (CPX 200) versus CPX-351 100 units/m2 on days 1, 3 and 5 (CPX 300)
Arm E CPX-351 (200 V 300)
If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1 fashion between CPX given on days 1, 3 and 5 (3 doses) and CPX given on days 1 and 3 (2 doses).
Arm F
Prior to Course 3 - Patients that received DA plus GO in course 1 and MRD negative PC1
Randomise between Daunorubicin 50 mg/m2 daily by i.v. infusion on days 1 and 3 (2 doses) Cytosine Arabinoside 100 mg/m2 12-hourly by i.v. push on days 1 - 5 inclusive (10 doses)
versus
Intermediate dose Cytarabine (IDAC) schedule Cytosine Arabinoside 1g/m2 daily by 4 hour infusion on days 1- 5 inclusive (5 doses)
Arm F DA V IDAC
Following recovery from course 2, patients in the MRD-ve arm will be randomised between a further 5-day cycle of DA or a cycle of intermediate dose cytarabine (IDAC) as the third chemotherapy course.
Interventions
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Arm A Mylotarg plus DA Versus CPX-351
Patients not known to have adverse risk cytogenetics will enter a randomisation comparing DA with Mylotarg (GO) delivered at 3mg/m2 on day 1 of chemotherapy, with CPX-351 on days 1, 3 and 5.
Arm B Vosaroxin and Decitabine
If a patient is known to have adverse risk Cytogenetics at diagnosis they will enter a registration to receive up to 5 courses of Vosaroxin and Decitabine.
Arm D Small molecule or Not
The randomisation to AC220 or not will take place immediately before course 2 of treatment for patients who have received DA induction +/- Mylotarg, irrespective of residual disease status. Patients allocated to receive AC220 will be randomised in a 1:1 fashion to AC220 or no small molecule with a 1:1 randomisation in patients drawing AC220 between short and long therapy.
Arm C DA V FLAG-Ida V DAC
If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1:1 fashion between DA, FLAG-Ida (or mini FLAG-Ida if 70 years or older) and DAC.
Arm E CPX-351 (200 V 300)
If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1 fashion between CPX given on days 1, 3 and 5 (3 doses) and CPX given on days 1 and 3 (2 doses).
Arm F DA V IDAC
Following recovery from course 2, patients in the MRD-ve arm will be randomised between a further 5-day cycle of DA or a cycle of intermediate dose cytarabine (IDAC) as the third chemotherapy course.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* They have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia as defined by the WHO Classification (Appendix A) this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2). (NB patients with prior MDS (\>10% blasts, RAEB2) have received azacitidine are not eligible for the trial, but patients with \<10% who have failed a hypomethylating agent and developed AML may enter the trial).
* Patients should normally be over the age of 60, but patients under this age are eligible if they are not considered eligible for the MRC AML19 trial please contact the trial team for further information.
* Patients entering the Vosaroxin/Decitabine arm must be over the age of 60 and have known adverse risk cytogenetics.
* They have given written informed consent.
* Serum creatinine ≤ 1.5 × ULN (upper limit of normal)
* Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP). Men should be advised to not father a child while receiving trial treatment. Similarly women must agree to adequate contraceptive measures and avoid becoming pregnant while on protocol treatment. In both males and females these measures must be in place for at least 3 months following completion of Decitabine and at least 6 months after the last administration of Cladribine. The time period following treatment with Decitabine where it is safe to become pregnant is unknown. In the event of pregnancy at any point during the trial, the IMPs should be immediately stopped and the Trial Team should be contacted and pregnancy reporting procedures followed.
* ECOG Performance Status of 0-2
Exclusion Criteria
* They have previously received cytotoxic chemotherapy for AML \[Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy, is not an exclusion\]
* They are in blast transformation of chronic myeloid leukaemia (CML)
* They have a concurrent active malignancy excluding basal cell carcinoma
* They are pregnant or lactating
* They have Acute Promyelocytic Leukaemia
* Known infection with human immunodeficiency virus (HIV)
* Patients with prior cumulative anthracycline exposure (from prior treatment of a non AML cancer) of greater than 300 mg/m2 daunorubicin (or equivalent).
* History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before entry
* Pre-existing liver impairment with known cirrhosis
* Total bilirubin \> 1.5 x the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \> 2.5 x ULN
* Alanine aminotransferase (ALT) \> 2.5 x ULN
* Total bilirubin \> 1.5 x the upper limit of normal (ULN),
* Aspartate aminotransferase (AST) \> 2.5 x ULN
* Alanine aminotransferase (ALT) \> 2.5 x ULN
* Left ventricular ejection fraction (LVEF) \< 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\]
* Hypersensitivity to cytarabine, daunorubicin or liposomal products
* History of Wilson's disease or other copper-metabolism disorder
• Patient's serum creatinine must be within the local ULN to enter the randomisation. Patients for whom this is not the case can be randomised between the remaining options.
In addition patients are not eligible for the AC220 randomisation if they have:
Known serious cardiac illness or medical conditions, including but not limited to:
I. Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker II. Ventricular tachycardia or a supraventricular tachycardia that requires treatment with a Class Ia antiarrhythmic drug (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
III. Use of medications that have been linked to the occurrence of torsades de pointes (see Appendix for the list of such medications) IV. Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker V. Complete left bundle branch block (LBBB) VI. History of long QT Syndrome or a family member with this condition VII. Serum potassium, magnesium, and calcium levels not outside the laboratory's reference range VIII. QTc \>450 ms (average of triplicate ECG recordings); a consistent method of QTc calculation must be used for each patient's QTc measurements. QTcF (Fridericia's formula) is preferred. Please see the trial website for QTcF calculator.
60 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Cardiff University
OTHER
Responsible Party
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Prof Nigel Russell
Prof
Principal Investigators
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Nigel Russell, Prof
Role: PRINCIPAL_INVESTIGATOR
Nottingham University
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Herlev and Gentofte Hospital
Copenhagen, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Roskilde Hospital
Roskilde, , Denmark
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Monklands Hospital
Airdrie, , United Kingdom
Ysbyty Gwynedd Hospital
Bangor, , United Kingdom
Royal United Hospital Bath
Bath, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Birmingham Heartland Hospital
Birmingham, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Ysbyty Glan Clwyd
Bodelwyddan, , United Kingdom
Pilgrim Hospital
Boston, , United Kingdom
Royal Bournemouth General Hospital
Bournemouth, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Bristol Haematology & Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
UHW
Cardiff, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Cheltenham General Hospital
Cheltenham, , United Kingdom
Countess of Chester Hospital
Chester, , United Kingdom
St Richard's Hospital
Chichester, , United Kingdom
University Hospital of Coventry and Warwickshire
Coventry, , United Kingdom
Derby Teaching Hospital
Derby, , United Kingdom
Russell Hall
Dudley, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Hairmyres Hospital
Glasgow, , United Kingdom
The New Victoria Hospital
Glasgow, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Royal Free Hospital
Hamstead, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Crosshouse & Ayr Hospital
Irvine, , United Kingdom
Kettering General Hospital
Kettering, , United Kingdom
Victoria Hospital
Kirkcaldy, , United Kingdom
Forth Valley Royal Hospital
Larbert, , United Kingdom
St Jame's University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
The Royal Liverpool University Hospital
Liverpool, , United Kingdom
Guy's Hospital
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
The Royal Marsden
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Maidstone District General Hospital
Maidstone, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Milton Keynes
Milton Keynes, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Norfolk & Norwich University
Norwich, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
Royal Oldham Hospital
Oldham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Whiston Hospital & St Helens
Prescot, , United Kingdom
Queen's Hospital
Romford, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
Wexham Park Hospital
Slough, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Stafford Hospital
Stafford, , United Kingdom
University Hospital of Royal Stoke
Stoke-on-Trent, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
St Helier Hospital
Sutton, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Torbay District General Hospital
Torquay, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Hillingdon Hospital
Uxbridge, , United Kingdom
Pinderfields Hospital
Wakefield, , United Kingdom
Sandwell Hospital
West Bromwich, , United Kingdom
Wishaw General Hospital
Wishaw, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
Worthing Hospital
Worthing, , United Kingdom
York Hospital
York, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Marianne Severinsen, MD
Role: primary
Hans B Ommen, MD
Role: primary
Claudia Schöllkopf, MD
Role: primary
Ulrik M Overgaard, MD
Role: primary
Duruta Weber, MD
Role: primary
Peter Møller
Role: primary
Dominic Culligan, MD
Role: primary
John Murphy, MD
Role: primary
Jim Seale, MD
Role: primary
Chris Knechtli, MD
Role: primary
Mary McMullin, MD
Role: primary
Manos Nikolousis, MD
Role: primary
Charles Craddock, DPhil
Role: primary
Paul Cahalin, MD
Role: primary
Earnest Heartin, MD
Role: primary
Charlotte Kallmeyer, MD
Role: primary
Joseph Chacko, MD
Role: primary
Sam Ackroyd, MD
Role: primary
Priyanka Mehta, MD
Role: primary
Kiran Tawana, MD
Role: primary
Steve Knapper, MD
Role: primary
Adam Rye, MD
Role: primary
Arvind Pillai, MD
Role: primary
Santosh Narat, MD
Role: primary
Beth Harris, MD
Role: primary
Ian Amott, MD
Role: primary
Rupert Hipkins, MD
Role: primary
Sudhir Tauro, MD
Role: primary
Peter Johnson, MD
Role: primary
Jason Coppell, MD
Role: primary
Mhairi Copland, MD
Role: primary
John Murphy, MD
Role: primary
Gail Loud, MD
Role: primary
Adam Rye, MD
Role: primary
Panagiotis Kottaridis, MD
Role: primary
Caroline Duncan, MD
Role: primary
Mahesh Prahladan, MD
Role: primary
William Gordon, MD
Role: primary
Mark Kwan, MD
Role: primary
Victoria Campbell, MD
Role: primary
Hugh Edwards, MD
Role: primary
Richard Kelly, MD
Role: primary
Katherine Hodgson, MD
Role: primary
Charlotte Kallmeyer, MD
Role: primary
Vikram Singh, MD
Role: primary
Amit Patel, MD
Role: primary
Kavita Raj, MD
Role: primary
Mathew Smith, MD
Role: primary
Matthias Klammer, MD
Role: primary
David Taussig, M.D
Role: primary
A Khwaja, MD
Role: primary
Evangelia Dimitriadou, MD
Role: primary
Eleni Tholouli, MD
Role: primary
Mike Dennis, MD
Role: primary
Ranjit Dasgupta, MD
Role: primary
Ray Dang, MD
Role: primary
Moez Dungarwalla, MD
Role: primary
Gail Jones, MD
Role: primary
Jane Parker, MD
Role: primary
Angela Collins, MD
Role: primary
Nigel Russell, MD
Role: primary
David Osborne, MD
Role: primary
Paresh Vyas, MD
Role: primary
Patrick Medd, MD
Role: primary
Robert Corser, MD
Role: primary
Toby Nicholson, MD
Role: primary
Paul Greaves, MD
Role: primary
Rowena Thomas-Dewing, MD
Role: primary
Jonathan Cullis, MD
Role: primary
Mark Offer, MD
Role: primary
Deborah Richardon, MD
Role: primary
Paul Revell, MD
Role: primary
Srivinas Pillai, MD
Role: primary
Shikha Chattree, MD
Role: primary
Simon Stern, MD
Role: primary
Unmesh Monite, MD
Role: primary
Deborah Turner, MD
Role: primary
Bryson Pottinger, MD
Role: primary
Richard Kaczmarski, MD
Role: primary
Paul Moreton, MD
Role: primary
Farooq Wandroo, MD
Role: primary
John Murphy, MD
Role: primary
Richard Whitmill, MD
Role: primary
Nicholas Pemberton, MD
Role: primary
Santosh Narat, MD
Role: primary
Lee Bond, MD
Role: primary
Other Identifiers
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AML18
Identifier Type: -
Identifier Source: org_study_id
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