Clinical trial: NCT01529827
Section: Confidentiality
Subsections: Authorization

As a participant in this study, you allow the use of protected health information for research poses. You understand that PHI will be used/disclosed by RPCI/WCHOB as indicated in this document.  You understand that you have a right to withdraw your authorization for use of PHI
in writing, but that information which has already been used or disclosed before your written withdrawal will continue to be used for research purposes. Finally, you understand PHI that has been disclosed by RPCI/WCHOB through this authorization to the study sponsor, FDA, NCI, NIH, or others may be further disclosed by them, as the PHI will no longer be protected by the federal privacy laws.  
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RPCIIBBandUBGVWBAPFWOVSP liTvno dmimi  
  
  
M. Page 20 of 21 V.4  
  
TO:  
  
  
  
p\d^. Participant Harae:
PATtEM'S STATElVIEfifT GONSE^TfVOLuNTARY COIN^m^awrer^
f ha^^een given a copy of all 21 pages of this document. The document mcludes no attachments^  
- You have been told of the re^ons rfbr this study.  
  
: ISu "
. fsad fbis/COttsent docuinenf gnd will receive a signed'copy tff ftBJbnn.  
. You do not waive any legal rights you have under federal or state laws and resulations.  
- Ypii yiifingty-fflye your consent to Yoluntarily join In this resealren study,
check box if Participant is < 18 yrs of ago (Child) and complete Parent/Legal Guardian infrHitiatioti lielow:
Child's Name (FR1NT)
Par^nVLega! Guarciiaii) (PRilNT).  
Reiationship fo Partieipant.  
l.y Parent/Legal Guardian Signature . . .. - -~P^te— ^me-
%
Trr
: a. ÿ Check box for Assent of Participant {applicable to children frdm ages >7 years)
)¦ By signing this form, I agree mat the study has been explained to me arid I have hadlhe op^rtunity to i ask questions and I agree to be in this research study.  
j (print) Name of participant Signature of partiblpaht I b. p Check box if Assent of Participant (children from a0es >7) is NOT appilcable for any reason.  
Check Boxif Participant is 18 years or above and complete Participant information below;  
Participant Name (PRINT) —, - —1 : : B '  
iDsrte Twrie  
Participant Signature •—— -  
  
  
fSn Pfotdcoi 1177110 DS# mZ
- ¦ > a i vA
Partfcipajit learner:.
LAptis 'ÿ Needed O Noldeeded Jnltials pf Persioft Obtaifrtng Consent  
  
  
  
As Ihg legstly aufhorized represeritafive for (PartiGipahts Nffle) ; ^ i;' |^S^S!uirf0n his/her behalf to partiGipate ih this research siugv,, My decisioft'i? based pn wh^ I ^.eligy^ he/s^would choose for bim/hereeif based on the infermafiofii \me received about me 'reseaffch. By. signirig mis Torm, i do npiwatve^ of fils/herrigtits, LAR Name (PRfMt)._ —  
Relafipfishlp io ParfiGipant  
LAR Signature P&te—= —  
t ft Persoft OBtaming Coiitsent (P! or Designee): _
1 GsaiSfy thit ttie nature -and p-urpose, pptenfial benefits and .possible nsksassociated wifti m this feseafttfi' study:! have been ej^iained to .the above Individuals) 3hd ©sat ^5^5 sbpyt-^i$
informafiofi haye been answer?! A dgned: copy of this consent Will be. given m the Parent/Guardi^
Participant or LAR
Person Obtaining CPnsent/Permi$sipn N?me (PRINT); r^_ - ^—1  
Person QbtsiiRlng Conseflt/perniissipn Signature:: Dale TirR'e:  
Witness:
t ce® that the individuals hatn^d above ag "ParenttsJ/Legal g^ardian(sf "Participant,^ 6r Participant.  
(> ig yrs of age) and 'Pefspri ofetamrng ctort§e!^VpBr^niss10n/asse^^t,' signed this documem m my preseft^
Witness Nfflne (PRINT);  
  
  
| Witness Signature:   |
|----------------------|
Clinical trial: NCT01529827
Section: Duration of Study Involvement
Subsections: When Does This Authorization End?

This authorization has no expiration date. The researchers may continue to rely on this authorization to obtain and use protected health information about you unless you revoke this athorization in writing.  
What happens to my health information after it is given to others?  
If you sign this form, and the information is given to other people, businesses, or government agencies, the information may no longer be protected. There is a risk that your/your child's information will be given to others without your permission.  
Any future study using this information that falls outside the scope of this current study will be required to follow guidelines designed to govern access to that information and to protect the privacy of that information.
Clinical trial: NCT01529827
Section: Participant Responsibilities
Subsections: ¦4. Whlf Wttt/Ffafpktsrif Ydtf Atte On The Study?.

Theigoalofa ttans^ant is tt r^lacefe defective c^ll? ie^oiisMe cells ftditt Vour donoi". Yotl. will first ^ve tests doae to make sure that you arelieallfay enough fo haveaBMt These tests will include: x-rays* heart,, lung and kidney function tests', and too^ ^
tests.  
(ivefvieW
SXt-SinSaSnTlteinLucLofthe"sterneeSk" (Wotecells«will eventually develop into "white blood cells, blood cells and Bfeelets);
remmenis given in hospital and most patients remain hosprtalizai for 4-6 weeks after starting. _,
tlje ^nffljntHny Longer h^aalkationTnay beTeqnired if you develop complications,, i After vou are discharged, you toay need to be seen in the doctors office several times a week; , The frequency ofyour visits wiU decrease as your/your child's condrtion improves, but you may need to:fetum every T-a weeiss during lhe first six monflis, Graft-vcrsus-host disease (attack by the donor cells against your organs) may begin ^en Moo^l amnts start to recover iut may be delayed as long as 12 weeks. After the transp ant, you wrll' receive medicines to prevent«lower the fsTnontte^ m?S'
lower the immune ss'stem's reactions and will be continued for at least 2-3 months. .,^
This is a difficult treatment that requires the use of powerful medicines. You wll fCma-inmthe hospital until your blood counts are at a safe level and you have m ^?s V 5 improvement in blood counts is 1441 d^^fts^^twe ^m;theh^^«_
«eeks Longer hospitalization may be required if you develop comphcations. The doctors wlH
rWrmim- when you can safely go home., After discharge from the hospital, we mil contaue fo follow you very closely. Your response to this treatment will be evaluat^ psnodiCaUy forjhe rest of your life. You and/or your physician will be contacted at regular intervals accordingly. ^
,t}- i, Protocol \#1 1177110 Page 5 of 21 V-4 Participant receive the chemotherapy drug Fludarabine, ^wsww m? -
m^r^L^fm taLion foKour (4) days. You will receive Melphal® 75mg/m2 by TV
be 'Known as "Day 0" or the day of transplant. Kludarabme will be given on Day -5 through Day fa&tions given at least six houis a^art on dav -1»
TTnmimo?mpbi^ssive:medication as i ictiown as urarK-yeirsiis-ni?^ i/i5>ca.ȴ kv' w/- v rUWca;c\ ^ hnv -1 '
well as (jVHpj you will receive the: drug knpwn as Tacrolimus (FK506) feegmnmg y, ^
until at least day +60 afteE wMcitheFK^Q6 Will bdiWi ¦; *
i—suppreL-e agent (weakens the immune eelb).  
new Stern eeils (donors, stefli ceils) ftfia reBQpang yow fe)«fe another immunosuppressive agent, will be started on day -1 and
+30 then it ^be&contiiwed.. A third immunosuppressive agent,. Methotrexate (MTX), Will
+iUUien itwu^oi ^ Tmmunosupnressive medications may br - be given 2.5mg/m2/'dcse IV on days 1, 3, and 6. Ifflffiunasupiess.vs ol^nw-H or extended for a longer period if you develop graft versus host disease (this is dis&issed fiirther in risKs);
aMtoik to iJ^ctUsi blaod. W. ^rea^'
the niifltber of red blood cfcUs b youT'system; platelet trMsfitislorts,to assist iniieiping yoiir 0,0^
SSSJSSSSSSSSSte wrt sometime afterDsy^QOandasepaiate ^
conseiit wiil he taken.
Clinical trial: NCT01529827
Section: Participant's Rights
Subsections: I^Wftat If Yfitt Have Oflesuons?

You are free to ask questions at any time about this study and to ask for more the doctor identified on this consent. If you have any questions, concerns or complaints about this study, you shouid contact Hong Liu, MD at RPCI {716) 345-8614 or WMratente^ TO
at RPCI (716) 845-2333. In case of an emergency after regular hospital houre, 5'°u sl,°uld telephone: RPCI (716) 845-23Q0 or WCHOB (756) 878-7000 and ask for the pedtatric oncology doctor on ealL
a result of your paitMpation emi cali fcRosWeU ¥z± Cancer fiStaePMeiit Advoc^e (Support) OMce ^(7X6) 8454474 Ot fe Wmm &> CHldren4? SpSpital: (716) 878-7551 of 87?-7981, You should also feel free to contact (he Palient Advocate Office at "s^| pwtidpafen, during parficinafion: <* once your participat.on « complete office^
unaffiliated with any specific research study. They can help you obtain additional informatito regarding your research participation and your rights as a research subject or hpw to procted shodd you feel you have been injured as a result of your participation, fhey are available to discuss any problems, caneems, questions or input y on nsay hafe
..  
IS. WTTFRF, HAN r FIND MORB TNKORMATION?  
You may call the NCI's Cancer Information Service at l_800-4-CANCER (1-800-422-6237) , _ H
A. descfipttm of this cfimcd trid wiH be »faMle by!U S Law The Web site will not include information that can identify you. At most, the Ws, stewiU include a sUmmafy of M resale You m seaishtlus^eb ®te at ®?y time, . u Ftir aecwats esaeer infofflfflSm in.cinding.PPQ, visit http-//cmc»meL;nciJiili.gov ; ,
V- '  
  
ttfefmissioii to the- folld^Mg pm^dersto.W ot flismose treiease^ yuuLp,^ ^ - —^ .  
that We maytise ahd/ox disclose can. ideitfify you iii tlie following ways.  
Buffalo.  
T, .-HHinn to researchers this study njay be ^sociated withcettaittcompanies m&gwvnmti and how thoy mayuse it.Wc also want«»tell you about yoiir rights before you agree to take part hi Ms study.  
wild may anf! yive outInfnrMation abtftttyoti? . _ A^nh^
The study doctor ajid research stellwiSl have this information and ma)'give it to others during and after the study., .  
yuAypiouuva ««f4V4>»6. »— m— - ¦ •• ••»- --
see this inforrnatipn during.and after the study.  
The following people, ageneies and businesses may also get mibrnmtion A""' you:
> Doetors and healthcare professioiials-at other sites taking part mthe istudy
. Doctors and healthcare professionals at Roswell Park Cancer Institute/Wotnen &
. Se JSonSraw D^rPmgram and Ae Center for W,7^^1aD(i MmT0W
Transplkrit Researdi, br^mrfohs iriwived iji research on blpod.and m^rrpw
- Members of the Btrfdind ManoW tmnsplant Ciimoal.Tnals Netwodc
* US Food and D^ug Administration (FDA) •;
us D^artment of Health/and HumiB Seiroes (DHHS)
- National iasntiiteot,.  
r-5EK»i w«m mm crnm^ *mm*wmm»
Children's Ilospilal of BufTalo and/or their affiliates SS^S^sS5.,«,» ^:
take part in ftiis study. This may include the following:
. information from the procedures used to find out whetheryou are/your clnld is eligible to take part in this study. This may include physical examinations, blood and urme tests, x-raysLd other procedures or tests, and any other information that you may release to us.  
Including information about your/your child's health history. ^ '
. Information obtained in the course of the study including mfonnat.on ^ ^"¦'/your child's response to any treatments j-ou receive, information related to study visits and Phone calls, physical examinations, blood and urine tests, x-rays and other procedures or tests, and any otfier information about your participation in this study.  
ww wiTl rtns mfnrmatinn he nSieH anfl/ttr shared?  
ThJwfQmxtiQ* ttat may idefttiiy ybii will toed researeh Stiidyv Tke :Spbtisbr"^lll an^ym<te;st) :Qfid eval* th? results ome-study, Tfie its agents! gOTeninent agencL, and others may visit the research site to follow how th* study k brfagdone and tuayi^ew ym ^Ormatipa for thispurpose.  
This information may be given to the FDA. It may also be shared with other governmental llas TTr,T*-ZlL. JL smm**. This isdbtte.fox'PStticicant firotectitaj mi m the sponsor can receive marKeung appiovai. iui mxj m—i The information may also be used to meet the reporting needs of the governmental agencies
"Iftesafe of feis^archmay fepuMisto to scfenfific^rnals^^ot^ntedWnMM
meetkgs, to yov^yoiff child's identity frill not fee disclosed (^h^re\#
The infpnnation may be reviewed byte IKB.atW^«nfl WCHOB and its affiliates, \#10 ..  
psffetm isviBWof .rcs^rdi .as aee^d by law.  
PHI may be .used mi disclosedin tfe? creation atfdmaintenance of 9 mSmWW^onn^ltenb^:^ ,
further JRB review and approval. This information can be fcept indefinite y. ^
Protoool \#: 1177110 Pa^-l8.of2i V.4 Patlici^MtH^raet MR\#;'
uoa-^esearch felated Bealtiti care tei-e.  
saasBSSS^Sffissa^sa^
gaaainsaasgsgs.  
you are withdrawing your authorization to use and ^^f^^nnaftwL J
address U; l)r. Hong Liu ORUr. Barbara Bambach, Roswcll Park Cancer Institute, Elm & Carlton Streets, Buffalo, New York 14263.  
If ybu should die while enrolled in or after taking pat m be ^ 01 *
Ifall information that dops or can identify you is removed from your health information, the ^
remaining information will no longer be subject to this authonzahon and may be used or .  
disclosed for othen purpDseSi Access to your/your child's health information ^ abated record setrs described aU»
Notice of Pnvaqy.P^ctices prMded to ybu feyMCFWCHUfJ, ^
if it frwemtfteyw ww ap^ftestow^ywt *» to yoUiOT y013r referring or primary care dpctor.  
Protocol \#.  
177110.  
V.4 Page 19 of 21 Participant Namer M
Clinical trial: NCT01529827
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: E W«An?Tsk-S Antl Mschmforts Ask Tnvolvep?|T^Thp ^Rmtttfiferadv (Fliidarabitiev Iflelphalan)^ Radmfion (Tbi) Anji Nieflicatons Fmethotrexate^^Crnliiniisand Cdfcepq Used M Tws Program May Cause All, Some, Or None Of The Side Effects Listed.|Likely $Ide Ffiecb: Fludarabmk|Metotrexate:|Less Likely Butinot Serious Side Effe#S 6F Evhdi|9. Reprodttctive Risks:

.,,, rmif rtrihf 4. » r^"rPknnwnld have an eTtremelv high complication rate, i jssraasagfl-1 .,.  
ao ^eryfung we isan; to present aiid ire^'any^mplications.  
While you lake part in fe study, you may be at risk for following side effects. YaU^WU
The drua (sVprooedures used in (his study may cause all, some, or none of the side effects listed..  
ITiere may be other side effects of the drugs/procedures that we do not know of yet. , ^
The Side eiTects may be mild, modemie, or severe. Many side efieets go away shortly after the stops tut occasionally, side effects can be serious, long lasting, or may be peimanerit.  
possible to teU whieTside effect w-Ul affect.you or how mi d w severe the ^
might be. We can only tell you what other people have expsriehced. Mease talk wi y ur , ...  
afeouttli&se sid^e£fects:.  
It isYory important that you notify your doctor right away about any side eflects, ^oblrans, or will decrease the chancetfiaC tke side effects contmue or bscomt worse. bt>iaeti3nes^ere ar. ^ ^
ofher medications that we can give yow to inake the side betterof rn^ypu njore comfortable. If severe, sifr effect dodeyeipp, you and. yonrdpctar my&&&&mnyw bft interest W stop tsMng prtintlie study, - ^
are. gs f^^feRftecfe those that occiff in approximately 15%- 30% of persons who receive this drug/tmdergt) this procedure.  
Less Side Effects: those that occur in approximately 10%-14% of persons who mceh'e ^
TtniilrrfvSidaEtffefcfe: tliose that occur in approximately 5% to 9% of persons who receive th.s Tsei^us^d e^Effeets: ThosS flat occur in less lhan 5% of persons who teesm tMs^.  
•dnig/imdergO this procedure.  
^1 iJ <

•rhe. «ide effects may be mild, moderate, or severe. In addition, there -.s always the nsk Softer side 'ff-Hc birring that are not vet known. It is,very Jmparfaiit lhat you notify y°^ do°lor r Pht ™b~y sWe effects, ^oblems, or unusual experiences you may have wMe taking SSioa TOs will reduce likelihood that the side effeete conUnue or become .severe.

- TMnessi weaiaiess; . .. , .  
. Lowed white blood cell count thatmay lead to mfcction.  
T,owered platelets which may lead to an increase in bruising or bleeding. . t
. f.owercd red blood cells which may cause anemia, tiredness, or shortness of breath. ;j
« Mucositis- damage to the lining of the mouth and intestinal tract cSusmg sores, painful, swailowing, infections and diarrhea. <f
. xn^p^«l risk nf fefeetions;^ or without fever
< Loss of appetite and/or weight loss.  
- piaarlieai nausea, vomiting.:
- .Cizz^nesSj joint and musele aches,
- peeling, itching}
Melphalan:
« Tiredness, wedaiess _ , t
« Lowered white biood eell count that may lead.feiiifet^on.  
. Lowered platelets which may lead to an increase in bmisiag or bleeding.. ,
- Lowered red blood;e:eUs*H\#may cause anemife tiredness, or shortaess of breath.  
. Mucositis- damage to the linmg of the mouth and intestinal tract causmg sores, painful swaflowiiig,. mfections an;d diairhea.  
- Increased risk of infections vdth or without fever
- tm Qfapfiefite and/ot wdghtloss.  
- ma^hea,.tiausea, vdtriiiing.  
- Jjizziftess, joint and m^scle aChes.  
- Rash, peeling; itch&f.  
! H^llMortW^ks after the last dose of chemotherapy, but will grow back when cbemoiheiapy is discontinued. The hair color may change, and is sometimes curlier.  
. PoSsiM'e st&iJity- loss of Wfliiy to beat children.  
SKUU«<
Ea^iajtipn (TBT):
« Mouth and throat sores it Pain
- Diarrhea Jswpda Swollen salivary glands
- Dry mouth
- SHn redness'
- Haii loss
- Fatigue
- Lqiw blobd tpunts
- Posaibl^ stenlity- loss of ability to beffl- children.

- Tirednessj, weakness. .  
¦« Lowered white btood cell comt^at:may leadto. infection.- j
- Lowered piatelete which maylead to an^crease iiilmiising- or bleeding.  
- Lowered iedModtl ijfells which iflay cause anemia, tiredness, or shorfeess ofbreath,
- Mucositis- dania^ to the tfnmgaf the mouth and Itttestinal tract causing sores, painful swallowing,. Ite^tions and diarrhe^.  
- In&e&iZd nslt, of Sections with or without fever
- Loss of appetite ^ud/pr wei^it loss.  
$ .Dkfrhga, nausea, v0ittititi& , , .  
- Hair will faU oul 1-3 weeks after the last dose of chemotherapy, but will grow back when chemotherapy is discoRtimied. 'Hie hair color may change, and is sometimes curlier.  
- .Possible sterility- loss of ability to bear children.  
Tacroiimus:
- Highblopd pressure
- ^skofM^oxi
« Feelin^tezf
- Headache;
- Nausea of! vanarfifig
- Diarrhea il'
- In^ality to sleep
•: Sunburn Cellcepft
••
'• Nauseaoi4 ^oiriiilng f Afteriiia;, low wMte Wood cell couiit, and low platelet count Itarc b^™Ut® ^ Sdy togans- suchaslhe heart, lung, train, kidney or ^ organ faih!rs' Thm^ 5«ppprtor eyen be^1 lat<* effects ttiay pCcur niaiiry^s^r tesplant-vi^Qhang^ liearmg 103% ^5™
fimctipn abnormality loss of bone strengt^risk of leuteiia t>r second cancers.  
-y r^ii reinfiisirtft is associated with' the follO^ng hazards: . _ ,
~ rwvvm shortness of breafh dtie.'to. thfe lodging of smil parhcles in the blood Thi? is aless Uk-ely«lde efcii b If the bone manrow or stem cells that are to be used.h^e b^cp^opi'e^xved
/frozen), a mmM called DMSO (4m^tiiFls^xide) isijsed^iflgthefteezmg process, this ch^nicaU* used to protect the cells tom-dainage dnnng fre^n^. ^
DMSO pr^dt^es w odor on the breath that lasts 1 to 2 da^; In .rare instances, severe aljer^eructionrnay occur.. , ^
C 1-hcre is also a chance lhat patients may develop 9 Wood tmnslusion reaction during the reiafrsioa of stem cells, lit that case, patients may develop the following less likely side effects: chills, back pain, decreased blood pressure, chest pain, and increased rate of breathing. Wheezing hives and rashes well as difficulty breathing) and inereased heaitrate consioered unlikely., Rafeiy,
.tem|)6rary life sufrpbrt with aitifidal ^entilatipn.is;r^iiired..  
d Failure to engraft is a rare complication and Stis possible ftri your own bone 1 •
marrow might grow back. A second transplant may need to be done.

- TmgTmg of the fingers and/or toes.  
- Weight gain and/or swelling.  
•. Insomnia.  
- XAiog damage (scarring of tlie lung - which is unlikely)?  
- leaver damage (unlikely),
- MbufE an4thr0at;sores, ,, ,, . ,
- Hives,, iriciuding severe rash leading to sloughiitg of slan and mucous membranes. -
- Kidneyd^nage(rare). , , .. _ •
9 Red blood cell4estmcti6n by the immurie system. Blood,may be. present m yourunne,. .  
- fiicoordinadon or a temporary unsteadiness when walking; (rare). *
- Hypertension ®gh blood pressure - which is likely). -y , ,
- Chestpain (unlikely).  
Heart damage (rare),
- Visual or Heating loss (rare).  
Protoesi\#; \wm Page 12 of ai V;4 m\#;

inyolye risks to you or your tofeoim-elaild that are iiot \mm m time therefore, you shoifld not Become: prepa^ ^r. fate a feaby ^I^pn ^is ,
shotJld not fiurse ySur baby while oft this stady. Females of childbearmg be required tc? take ^e^ancy te^befee being ^Jow^to feke Taking this medication/treatment now could affect,your ability to have childrai at a later time.  
You will beaked to practice an effective method of birth eontolwhiie you for a time after your treatment ends. This iffitafes, bulls t wiM} condonismth s|penn?cide? or abstinence. In females of childbe^ing.age,,bir^.cbntlshould continue for six (6) months after the last treatment to insure *c d™^fatole^| cleared from the body. Sincfe interactions between the study drug ^ w01 h"11 P
cannot be ruled out, a "barrier" method of contraception (condom, diaphragm) must be used as
^certaineases,oral biiffi&atfoi\#* ea^W^ftfWAW««L
your'dbctot To the best of your knowledge, you are not pregnant and do not plan to become preenM^ while SSSSsS Should you become piie^mMttfiBgthiis.Efttid^ybiJ vstt ^
SToSy and obstetrician. If you wish you may request 8 referral for counsehng
(such as genetic couflseior,. social Woiker, or psychologist)
TTtete is the possibility that this treatment could affect the ability ofchildren and adolescents to hayeiWcta at a later time. Ask about counseling « more mfiwmation about preventmg pregnancy. Bregiamcy tests may be xepeated during the sttidy,. i IvSen^iits must use an effecfive method of biilh contrbL Th^ •can Mudei biit is hot linnted fo tonH wS^Mrablinenee, or having a vasectomy, ^en taking p^ in Mdy, you should continue use ofbtrth conirol forthrS: moiiihs after rwe!¥»sfte feSt40» of to be sure the drug has cleared from the body. Males who are receivng 1,01 ¦
donate sperm for at least three months after the study is completed. Discuss birth control measures withyour doctors PfcotSPPi \#: ^
Page 13 of SI V.4 P^bipalit'Name; MM:
Clinical trial: NCT01529827
Section: Procedures
Subsections: ^ N Vnrj Takf Pawttn This Sttinv. What Trsrs Ano Procf,I>Ures Will Vot! Havk Done?

The foUowmfe tests must be done to make sure that you are eligible for this study. None of the' they are routine. Depending on ^en you last had them, you ,,
ina^ need to repeat spme of these tests: 13
- Blood tests
- Chest x^ray
» CTfMRl scan of the chest, abdpms^ and pelvis
. Heart fimclioh- EK.G, MUGA ftad/'or KCHO (a heart Scan)
. Pulmonary Ftffiction Tests (PFi) for lung funcUon evaluation
—YiraHests PregnMc^ test (if you. are. of chi^bearmg p&tefltial)
, Botie inaiTQ'w aSpii^te.gnd biops|
Clinical trial: NCT01529827
Section: Purpose of Research
Subsections: 7 Whatts Tpf, Wrpos^ Of This Stuby? F|Til What Benefftts Mat You Get From Ti&^ Sutfflvj

tWhave l,e«r> iimteito w&ipate in Roswell Park Cancer Institute and Women & Chddren s Hospital of Buffalo ^s^y'"
which you have been SsWt© fake part Witt dctemime wliat effects (good and bad) this treatment has' on you and your type of cancer or condition. . , ,t BMT is considered a standard form of therapy for many of the various types ofiiematoiogic - ^
malignancies or disorders. Your physician will discuss stei^c problem that you have withaBMT. Reduced intensify traflsp^OflffiTpisa BMT
technique that can provide an alternative to traditional htgh-mtensity BMT. Tliereisno guarantee or impjied promise that this treatment will be suceessfiil This research is being done because cun-ehtly, there is no effective treatment for these types of conditions for patients who may have ftdled previous treatBimts, This study us? a new^
combination and schedule of chemotherapy and radiation therapy to treat the disease.  
TOs study is being done by the doctors at the Roswell Park Cancer Institute and Women &
Children's Hospitai of Buffalo, The pnrp'oseof this s^idy is to attempt to. '¦<
&) slow of stop the; growth of your/yOur child's disease, or prevent it from recurang^ . ^
unfestand the usefulness and side effects of ihe treatment , cv -y

It is not known if ftis treatment «dn help you or not Possible top m^inc^e shrinkage or '
^»1TTr^rmirp nfymiT cancer This.WoilH * ^Te^Rem vditf symp.tgms^d, in yoiir quality oflifc. It is also possiblp ffiSKSfSSSS^^
lhe.study «'i!l help you. Future patients may be helped &om the results aiid mfDrmation gained
Clinical trial: NCT01529827
Section: Voluntary Participation
Subsections: 13.  Will You Be Paid For Joining This Study?

!!  
You will receive no payment for taking part in this study.  
u dis It is possible that this research project will result in developing treatments, devices, new drugs, or study.  
.  
..  
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mtoooW itDW i>^2642 Page IS.of 21 V.4 Participant Naitie:
um pf^idg this care free even if is a. feet result Gf paptieipatiijn, :;
Clinical trial: NCT01529827
Section: Withdrawal from Study
Subsections: 11 Tvnatrp Vot; No Not Thts Stijuy?

If vou do notjoin this study, you should discuss the options wth your doetof. ttismay include:
!. Ko trejitment, b«t medications and measunes to keep you comfortable. This is sometimes  
calle^supot-tive care ontyi
2 Usual/standard, treatment for your disease or condition may be appropnvle. This may |( include treatment with other drugs, drug combinations, ;fadfeW!  
possibly other, research programs here or at other centers, which may be testing new chi^fbryoi^t^e of eafleei:.  
There hao clear evidence that ote t^at&en^ are tnofe effective mm Feel to to talk wttkyour hed^-cafe team aboutyom* dise^e and ym treatment chQices. ^
h wn at wn .1, this cost? «
- ,! \
Examinatkms,, scans, laboratory tests, and Ar Wbat io&mm needed to mbmtor ml treat your toss are knom as standard pf care Chafees for these services will be billed to you and/or your insurance earner m the usual maiyier.  
^ou^lt SSe for co-payments., deductibles, and/or account balances as determined by your individual health insurance contract There are many different types of insurance plans and contraets. It is not ^'n ScrSSoutt vw insurance will pay ^d what yonrfmancal respo.Kib.l.ty w be^
if vou wish a financial counselor can meet with you to help answer your qMeshons regardmg, insurance coverage issues before you d\#?fo to prfcipate^ EKsstedy.^ a EmwJOmmIib:
can be reached at716r8.45r31.6:i (M-ifee-Raleida PatientAceoTiints Office ^116 859-720P, ( ,
A representative from the Patient Access Departaenl can help you obtaifl authonzations from ;
yottf insurance carrier when needed. A representative from the Patient Access Department can be reached at 716-845^1049. -i ?  
Date: 7^2/13 '» **¦l Protocol \#>
Page 14 of 21 V.4 Participant Name:
MR
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There are certain insurance plans that will not cover charges for any care related to an experimental or investigational therapy or study. These plans may deny coverage for even the routine, standard of care medical services you will need to receive during the time you are enrolled in the study:  If you have an insurance plan that does not cover participation in a clinical research study, or if you currently have no insurance coverage, a financial connselor can meet with you to provide an estimate of the costs that would be associated with participation in this study. A payment schedule can be developed if needed. A RPCI Financial Counselor can be required only for the clinical research study and are not needed for the usual care of a patient with your/your child's disease are known as "research related" services, Research related s.
1
- II
services will not be charged to you or your insurance, You and /or your insurance company will be responsible for charges related to the drugs and
.  
may be needed to prevent or control side effects.  
If you develop complications or side effects from your/your child's participation in this clinical research study, medical treatment will be provided at the usual charge. A RPCI financial counselor can be reached at 716-845-3161 or a Kaleida Financial Counselor can be reached at s  1 716-859-8516 to provide an explanation of coverage and to answer questions you may have the
- 1 regarding study related billing.  
a result of your participation in this research study, you can call the Roswell Park Cancer Institute Patient Advocate (Support) Office at (716) 845-4474 or the Office of Administration at
. I
the Women & Children's Hospital:  (716) 878-7551 or 878-7981..  
e
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