Clinical trial: NCT04146038
Section: Confidentiality
Subsections: Penmission (Authorizationt To Use Or Share Healtii Ttiforit'Iatioti Tiiat Identities You Tr'Or A Researcii Sttjdy

The next ferv paraggaphs tell you about lrow investigators want to use and share identifiable health information from your medical record in this research. Yom infonuation will only be tued as described here or as allowed or required by law. If you sigrr this consent fonn, you agree to let the investigators use yoru identifiable health infonuation in the research and share it with others as described below. Ask qtrestions if there is soruething you do rot urderstand.
Clinical trial: NCT04146038
Section: Participant's Rights
Subsections: Who May Take Part In This Study And Who May Not?

Any patient over the age of 18 who lras acute myelogenous leukemia (AML) or advalced myelodysplasia (MDS) or myeloproliferative disease (MPD) may take part in this shrdy if they are uot a candidate for aggtressive cheruotherapy- You may not take part in the study if you have certain concrurent illnesses or laboratory values that make the sfudy heatnrent likely to cause too many side effects. The study doctor aadlor research team rvill also ask you other questions about you medical history in order to make srue you qualify to be in this shrdy. A conrponent of this study rses standard &'eahnent with decitabine (or the related medication 5-azactidine) in conrbination with veuetoclax. These cost of these dnrgs are not covered by the clinical trial. If you irxurance does not cover the cost of these drugs (or the co-pay is too higlh) you will not be able to par-ticipate in the clinical study.
Clinical trial: NCT04146038
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Reproductive Risks|Will There Be Any Cost To Me To Take Part In This Stutly?

Both ruales and feruales will be iachrded in this shrdy. If you are pregnimt, you catrnot participate in this study. you should 1ot becorne prepinant or father a baby while particlpa,tln-g in this sttrdy because the dnrgs in t$s study cau be associated with milarown risks that could affect you or ar urbom baby.  
Atl subjects and their spouses or partners must use an effective birth control method. Some
***pi"* of birth coutrol are tlre-following: have had a prior history of surgically-induced sterility (i.e., tubes tied, vasectorny), avoiding auy activity.that could carme you to becoure pogr*i6"o sexual htercoruse), oi usirg birth controt pills, fUD, condotl or double-barrier
.ooiro"*pilon diaphragrl rvith spennicidalSelly, transclennal {through your skin) or injectable contraceptives.  
Whether you are a rxrn or woman, you must practice birth control dwiug the shrdy and for at least six months after you receive the last dose of the shldy drug. Before entering the study, you and the stu6y cloctor must agr-ee on the birlh couhol method you will use dtu'ing the entire study' A comrselor and morc infonuatiou about prevenfiug pregnancy will be made available to you if you have any ryrestions.  
FE
ff V ancy test (usurg a r*ine aud/or-blood sample) will be done andih" results must belegative before you are pennitted to eruoll in this shrdy. A repeat pregnaocy test must be done if you miss any periods or yotu menstnral cycle becomes iregular'.  
If you are ctur:ently breast fsgding a child and agree to participate in this study, you must stop breast feeding befor-e receiving the frst dose of study drug. You rtrust aefee to discontinue breast feeding for G eutir-e time you are participating in the sfudy to prevent any potential health risk or iojory to the ehild.  
If you become pre€pant while in this study, you ruust tell the study docfor as sooil as possible- The study doctor *ill -"duir* you of the possible risks to yoru'unbom child and options available to yo.r. B""u.rse of the possible risks to an unbom child, the study dnrg will be stopped. Yotr may
!e asked to receive medical follow-up services for yotuself during the prepnrancy and for the baby after birth. you may be asked to provide ruore information about the pregnancy and its outcome-

You and/or yotu insuarce coutpany will be billed for the costs of your b'eaturent that are considered staldard of care (for exaurple, doctorl Adrnanced Practice Nurse (APN) visits, mrsing car.e to administer the heatmenfs, routine lab tests, restaging scaas. etc-), standard dose decitabine
(or S-azacytidine) and venetoclax as you wotrld have received these serwices even if you were not participating in this study. You will be responsible for any co-payments due for office visits, co-ior*-*""* a1d deductibles due on any tests and/or procedures that are required and considered standard care. Salsalate rvill be paid for by the study (CINJ via philantbropic fixrds)-
Ifyou have any questions about irxurance coverage, including any out ofpocket exPe[ses you r"ight ilctu, oi which laboratory or facilities you are allowed to have tests at, a firrancial counselor will be made available to you upon request.  
Optiorral and/or research relate{itqlqqSggb as salsa!4te-lpggiillaboratorv tesfs aud research blood Wil I be paid to take part in this study?  
You rvill not be paid for yoru participation in this research study.  
How wiII information *bout me be kept private or confidential?  
All etTorts will be made to keep yotu personal iuformation iu your research record confidential, but total confidentiality carurot be pnraranteed.  
screerrs contammg r aud research team will have direct access.  
\ilhat rvilt happen to my iuformation or biospecimens collected for this research after the study is over?  
After infomratiol that could ideutiff you has been reutoved, de-identified collected for tlis resear.ch may be used by or distributed to investigators for other research without obtainilg additioml informed consent from you.  
What wiII happen if I am iujured during this stutly?  
If you take pari irr this study, you wilt be exposed to cefiaitr risks of physical personal inj"ry in additiot to those associated with staudard for:rx of teafinent.  
that resuit in personal iujury ruay be discovered. Please refer to sectior 'What are the risks andlor discomforts you miglrt experieuce if you take part in this sfudy?".  
The University will make appropriate refenals for medical andlor dental h'eahuent for subjects who sustain personal injuries or illnesses as a direct consequence of participafion in the research-The subject's health ius-urance carrier or other third-party payer will be billed for the cost of this heahnent; provided that the Uuiversity shall not strburit to federally fi.rnded p1o8&1ns, e-g-,
Medicare, Medicaid or CHAMPUS, for reirubrusement flrst if suburissiou to zuch progranrs is prohibited by law. No financial compensation will be provided by the University and no other type of assistance is available from the University'
Clinical trial: NCT04146038
Section: Procedures
Subsections: What Wilt I Be Asked To Tto If I Take Pcrt In Fhis Study?

If you take parl in this research study you will have a bone rlarrow biopsy before starti[g therapy ani after the second cogrse of therapy, usually at 2 uronths. There uray be earlier boue manow tests if you doctor thinks the test is nee<led to guide yoru treatment. You will atso have blood tests, soLtimes daily, as part of staridard of care. As part of the study there will be an additional 2 tubes (3 teaspoondis; of Utooa taken before starting therapy atd 1-2 days later and 2-4 days later. rie ,"fety of decitabine (or S-azacytidiue) in cornbination with veaetoclax is greatest if given wSen the total mrmber of leukemia ""tlr io the blood is below a certain level. If your blood cell count is above that level you will receive chemotherapy (pills) to lorver the blood courts to a safe level. The study rneclication, salsalate will be taken as 2 pills twice a day fior 7-10 days' The treatment also iucludes chernotherapy (decitabiue or 5-azacytidirre) aduriuistered over lh for 7-10 days and venetoclax for 28 days, given as l-4 pillslday (dependiug upon other medications being taken) for 28 days. The veletoclax may be intir:upted by yoru'physician for medical reasors'  
  
\ilhat sre the risks anr}or discomforts I might experience if I take part in this stutly?  
AML, MDS and MPD ar"e life{hreateuing diseases. Patients with these diseases often have very abnognal blood coturts. The average age of patients with these fiseases is over 65 years old afld mariy may have other serious illuesses. Patients with these diseases and abuonnal blood counts ate
,r"ry'r.o""ptible to infectiou, bleeding aud fatigrre. Any fi'eahneut for these diseases can rnake things "r"r, *or*" becarme blood courts may get rvorse as a result of the trcatment. In prior studies rvith decifabine or S-azacytidine in courbination with venetoclax serious side effects included fever in alnost o1e half (50%) of the patients, lolv platelet corurts and bleeding occufled in one quarter
(Z1o/o)of the patients, and serious infections occurred in one quarler (25o/o) of the patients' Other poteii* side effects include serious damage to your kidueys fiom a break dowt of cancer cells called hrmor lysis syndrome. Ttrmor lysis syndrome can be irreversible, resultirrg in rnultiple blood abnorrpaliti"r, kido.y faihre and ev-en death. Yerretoclax in cornbination with decitabine or 5azacytidile has also been associated with rausea, diarrhea, vorniting, fever, rash, bleeding, infectiol, uruscle pain ancl fatipnre. A low platelet cotmt and white blood cell corurt' which cafl cause bleedilg and infectiou is coulloo. Side eft'ects directly related to salsalate include darnage to the kidleys, allergic reactions, nausea. bleeding arrd hearing abnormalities as well as dizzi[ess.  
liver abnormalities, abnormalifies, abdornin"l paio, nausea, diarrhea, edema and somnoleuce' Sorne people takiag salsalate for rnore than 3 months have developed heart disease. You will be mooitorcd fo, these sitle effecfs. It is utknorvu if salsalate will have other turanticipated side effects or increase the side effects of decitabine (or 5-azacytidine) in coubinatiou with venetoclax' In geueral, AI\{L, MDS and MPD are litb-threatening diseases rvith high risk of infe to the organs. treaturent can mcrease toxicttres and result m bleediug; dor*g. to the lreart, hmg, kidney, liver. gastrointestinal tract, nerves and/or other organs.  
Sornetiies these toxicifies will be ineveisible urd ruay result in death. One patient heated with the combination of decitabine, venetoclax and salsalate had serious bleeding. Siflce thert the shrdy has been urodified to make sure all patients receive a uredicine that rcduces productio[ of acid in the stonrach- It is hoped that this will reduce the risk of stourasb irritation and bleeding.  
Since some genetic variations cau help to predict the firture health problems of you aod your relatives, this infonnation might be of interest to health providers, life iusuratce cornpanies, ard ot5ers. Therefore, youl genetic infonnation potentially could be used in rvays that could cause you or yolr farnily ecouomic shess.  
There are sfate and federal laws that protect against genetic discrinrinatiou- A federal law, the Genetic InformationNondiseriminatioo A"t makes it illegal for health insurance companies, esoup health plans, and most employers to discriminate against you based on your geaetic infonnation' This law generally will protect you irr the following ways: (l) health insuralce companies and Sollp heatth plans may uot request your genetic infonnation that we get froru this research, (2)
health in$u-ance "oo.p'*i.,
*A groop treattU plans r:ray not use you genetic irrfonnation when rnaking decisions regatding yotu eligibility or preuriurns; and (3) employers with l-5 or mol.e employees may uot io" yo*'g"netic infonuation that we get fiour this research rvhen uraking a decision to hiri, promotg o, irr* you or when setting the terrns of yotu'ernployment. However, it does uot protect you agaiust discrirnitation by companies that sell life insurance, disability insruance, or long-term care insurance.
Clinical trial: NCT04146038
Section: Purpose of Research
Subsections: Why Is This Stutly Being Done?|What Is The Purpose Of The Research *Nd How Will My Information Be Used?

The purpose if this study is to detenmne if the addition of a medicine called salsalate to stand*rd medicatious rned to treat patients with acute myelogenous leukemia or related diseases strch as myelodysplasia or rnyeloproliferative diseases will result iu additiorral side effects compared to the standard therapy alone. Salsalate is not approved by the FDA. Use of Salsalate to treat patieuts with acute myelogenotrs leukemia (AML), uryelodysplasia (MDS) or related diseases is experimental. This shrdy is being do:re because it is hoped that salsalate will enhalce the beuelicial effects of decitabine (or S-azacytidine) and the heahnent will result iu rnore people entering remission and having longer duratiors of remission.

You are being invited to take part in this research shrdy which is described at the begimring of this fonu. The prupose of eollecting atd using yotu health information for this study is to help investigators answer the questions that are being asked in the research.  
\ilhat information about me will be used?  
Yoru health information related to this shrdy may be used or disclosed io connection with this research study, including, btrt not timited to, information in yotu uredical record such as certaiu iufomration indicating or relating to a particular medical conditiou. blood and other tissue samples and related records, physical examinations, x-rays, MR['s, etc. Your personal identity, that is your rame, address, and other identifiers, will be kept cotfidential. Yotr will have a code number and your actual narue will not be used. Only your study doctor will be able to link the code nunber to yoru naule.  
Youl data may be used in r"igntific publications. If the furdings froru the shrdy are published, you will not be identified by nanre. Your identity will be kept confidential. The exception to this ruIe will be when there is a cotut order or wheo a law exists requiring the study doctor to report commturicable diseases. In this case, you will be iufonned of the iatent to disclose this inforuation to the state agency. Such a law exists in New Jersey for diseases such as cancer, iufectious diseases such as hepatitis, Hf\r, vinxes and many otlters-
In applications for marketing authorization yoru data uray be subnritted to domestic and foleigrr dnrg regulatory agelcies.  
Youl data uray also be sent to domestic and foreign drug regulatory agencies if you should suffer a bad reaction to the study drug.  
Who may use, share or receive my information?  
The following parties ale authorized to use and/or disclose yoru health iufomration in comection with this research stucly:  
  
The parties listed in the preceding paragraph ruay disclose yotu health inforuratiot to the tbllowing persons and organizations for their use il cormection rvith this research shrdy:  
o U.S. Food aud Drug Administation (FDA)
e The OfIice for Hunan Research Protections (OHRP) in the U.S. Deparlment of Heal& and Htuuan Serviees CIHHS)
Those persons or organizations that receive you infonlation rnay not be required by Federal privary laws to p.ot""t it and may share you information with others without your pennission. if permitted by the laws govemiug them.  
Will I be able to review my research record while the research is ongoing?  
No. We are not able to sharc infounation in the research records with you until the study is over' To ask for this infonuatiou, please coutact the Principal lnvesfigator, the persotr in charge of this research shrdy.  
Do I have to give my Permission?  
No. you do not haveto pernrit use of your information. But, if you d9 not give pernrissloo, you cannot take part in this study. (Saying no does not stop you from getting medical care or other benefits you arc eligible for outside of this study')
If I say yes noly, can I chsnge my mintl and take away my permission later?  
yes. you uray change yo*'*ioa and not allow the coutinued rne of yotu informatio[ (and to stop taking parf in tlie study) at any time. If you take away pennission" your infonuation will no lorrg"r be used or shared i" it "
rtoiy, but we will uot be able to take back infonuation that has oUiay been used or shared with others. If you say yes uow but change yo*l r"i"q later for use of yo." i"m"oution in the research, you must write to the researcher and tell hirn or her of you decisioo:
How long will my permission last?  
There is no set date at which yotu'authorization will expire. This is because the information used and created druing the study may be hnalyzed for many years, aud it is not possible to Luow when this will be complete.
Clinical trial: NCT04146038
Section: Voluntary Participation
Subsections: Consent To Tai(E Part In A Research Sttidy|Why Have I Been Asked To Take Pert In This Stutly?|Agreement To Participate 1. Subject Consent:|2. Signature Of Kvestigator'/Individual Obtaining Consent:

TITLE OF STUDY: Salsalate * Veuetoclax/Decitabine for Patients with Advanced Myeloid Il{aligrrancies Principal Investigator:
STUDY SUMI\{ARY: T[is conseut fonn is part of au infonned cousent plocess for a rcsearch study a1d it will pror.ide informatiol that will help you decide rvhether you wa*t to take part in ttris study. It is yotu'choice to take part or not. TIre purpose of the research is to: is to detemline if tt1e additioo oiu medicine calledialsalate to staudard rnedications used to treat patients wit]r acgte myelogeoous leukemia or related diseases such as myelodysplasia or myeloproliferative diseaseswiliresult in additional side effects compared to the statdard therapy aloue. If you take part il the research, you rvill be asked to have a bore nmnotv biopsy before starting therapy ar}d afier the seeond cotuse of therapy. You will also lrave blood tests, sometiures daily' If your blood cell count is above that tlueshold you rvill receive chemotherapy to lower the blood corurts to a safe level. The study medicatiol, salsalate will be taken as 2 pitls twice a day for 7-10 days- The standar-d componeot of the h-eahnent includes chernotherapy (decitabine or.5-azacytidiue)
arlmirristered over lh for 7-10 days for the firsi cycle. Venetoclax will be administered as l-4 pills/day (clepending upon other medicatious being taken) coutinuously rutless intenupted by yo* phyrician for rneAicat reasors. Your time in the shrdy will take generally I month. Patieuts enrolled in the clinical trial will receive experimental therapy for otly the first eourse of therapy.  
If the treatment appear.s to be controlling the disease, you rvill then continue on treatflrent with decitabine (or S-azacytidine) in corubination with veretoclax as standard therapy. Possible hanrx or brudens of takilg pafi in the study rnay be infection. bleeding, fatigrre. fever, low platelet counts, daurage to the kidueys, allergic reactions, uausea' and healing abnonnalities' a1d possible benefits of tuUrrg part may be rnore people entering reurission and lotger durations of remission. An altemative to takitg parl iu the research shrdy is no h'eafilent or staldard decitabine (or 5-azacy'ticline) iri cornbination with veletoclax: or inte[sive induction chernotJrerapy. Ttre data collected will be how well the uew combinatiori of medicatiotts is tolerated and-rvhether the conrbiuatiou alters the biological characteristics of the leukernia cells.  
We lvill also detennine if the combination is effective in treating the blood disorder (leukeuia' myelodysplasia or related disease). Yotu alteraative to taking parl it the research shrdy is not to take part in it and receive standard The infonuatiol in this consent form will provide more details about the research sfudy and what will be asked of you if you choose to take part in it. If you have any questions now or during the shrdy, if you choose to take part, you should feel free to ask them arrd should expect to be givelr aoslvers you completely understand. After all of your qtrestions have been anslvered and yotr wish to take part in the researrh study, you will be asked to sign this consent form. You are not givilg rlp any of your legal rigfits by agreeing to take part in this research or by signi[g this consent form.  
Who is contlucting this resesrch stutly?  
The Principal investigator or another meurber of the study team will also be asked to sipur this  
  
infonned consent. You will be given a copy of the sigued consent fomr to keep.

You have been asked to participafe in this shrdy because you ltave acute nryelogenou leukemia
(AML) or another related caucer that is in advanced stage as judged by blood or bone Emrrow tests. The related disease uray be called myelodysplasia (MDS), chronic myelouronocytic leukeruia (CMML) or a uryeloproliferative disease (MPD). Yoru'doctors believe that the best treatrnent for you is with a chernother-apy agent called decitabine (or fhe related uredication -5azactidine) in combination with a medicatiou called venetoclax. This cornbiuatioa is uew treahnent modalify that has recently been approved by the Food and Drug Admirristation for patients with AML who are not coasidered likely to get benefit from (or who have medical problems that preclude) itteusive cbemotherapy. These patients rnay be older, have concurrent
["tY to have druable beuefit fr om inteusive chemotherapy.  
  
Research doue at Rutgers CINJ have shown that an auti-inflarnrnatory medicine m the family of uredicines called saliiylates may improve the results of the combination of decitabine (or the related nedication 5-azaey'tidine) and venetoclax. Ifl this study we will |r.eat 20 patients with a salicylate called salsalate in adrlition to decitabine (or the related medication 5-azactidirre) in combination with venetoclax. We will detennine the side effect profile to determine if the salsalate causes any additional side effects. We rvill also do soure tests on your blood cells to see the biological effects of the salsalate.  
Horu long witl the study take and how many subjects will take part?  
patients emolled in thgclinical trial will receive experimental therapy for I course of therapy
(generally I month). They will then continue on treatment with decitabine (or S-azacytrdine) in courUinaiiol with veneto"lu* ,, stanclard therapy until disease progression or other reason for discontiluing therapy. They rvill be monitored for the druation of therapy with decitabine (or 5azacytidile) in combination with venetoclax A total of 20 subjects will be eruolled snrdy wide. All subjects will take part in this shrdy from the Rutgers CINJ.

I have read this eutire corrsent fonn, or it has beeu read to rne, and I believe that I understand what has been discussed. All of my questiorrs about this fonu aud this study have been answered. I agree to take pafi fu &is study.  
Subject Name:
Subject Siguahue: Date:

To the best of my ability,I have explairred aud discussed all the inrporlaat details about the shrdy iucludiog all of the iufonnation coutained in this cotrsent fomr' InvestigatorlPerson Obtaining Colseut (printed name Sigrrattu'e: Date:
Clinical trial: NCT04146038
Section: Withdrawal from Study
Subsections: What Wilt Happen If I Do Not Wish To Take Part In The Study Or If I Later Decide Not To Stey In The Study? It Is Yogrchoice Whether To Take Pad In The Research. You May Choose To Take Part, Not To Take Part Or You May Change Yotu Rnild And Withdlaw From The Shrdy At Any Time.

If you do lot want to enter the study or decide to stop taking parl, yoru'relatiolship with the study staff will not change, and you rnay do so without penalty aud without loss of betefits to which you are otherwise entitled.  
collected about but You rnay also withdraw your coffient for the use of data rnust do this in writins to If you decide to withdraw from the study for {ury re&son, yoll D}ay be asked to return for at least one additional visit for safefy reasons.