london ms hsct collaborative group patient eligibility criteria final

London MS-AHSCT Collaborative Group - Patient Eligibility Criteria Final V.3. – 8/12/2015 Patient Eligibility Criteria Adopted by the London MS-AHSCT Collaborative Group The eligibility criteria are overall aimed at selecting patients who have failed approved treatments of high efficacy or have none available to them and have recently presented evidence of inflammatory CNS disease activity; and who could undergo AHSCT with an acceptable estimated level of risk of adverse events. Justification for each of criteria is supported by evidence from AHSCT trials and observational studies. Referral criteria: I. Diagnosis of MS made by a neurologist II. Able to walk, needing at most bilateral assistance to walk 20mt without resting III. In relapsing MS (RMS), failed one licensed disease modifying drug of high efficacy (currently including alemtuzumab and natalizumab) because of demonstrated lack of efficacy IV. New MRI activity within last 12 months Inclusion criteria: 1. Age 18 to 65 years 2. Disease duration ≤15 years from diagnosis of MS 3. Diagnosis of MS according to McDonald’s criteria 4. For PPMS, CSF OCB+ 5. For RMS, failed at least one licensed disease modifying drug of high efficacy (‘Category 2’ as defined by Scolding N, Barnes D, Cader S, et al. Pract Neurol 2015;15:273–279; currently including alemtuzumab and natalizumab) because of demonstrated lack of efficacy (as evident from relapse, MRI activity as defined below at Point 7, or EDSS increase) after being on DMT for at least 6 months 6. EDSS score 0-6.5 7. Inflammatory active MS as defined by ≥1 Gd+ (>3mm) lesion (off steroids for one month) or ≥2 new T2 lesions in MRI within last 12 months 8. Approved by the MDT Exclusion criteria: a. Eligible for an ethically approved clinical trial where AHSCT is offered as one of the treatment arms b. Unable to adequately understand risk and benefits of AHSCT and give written informed consent c. Prior treatment with total lymphoid irradiation and autologous or allogeneic hematopoietic stem cell transplantation

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Page 1: London ms hsct collaborative group patient eligibility criteria final

LondonMS-AHSCTCollaborativeGroup-PatientEligibilityCriteriaFinalV.3.–8/12/2015

PatientEligibilityCriteriaAdoptedbytheLondonMS-AHSCTCollaborativeGroup

TheeligibilitycriteriaareoverallaimedatselectingpatientswhohavefailedapprovedtreatmentsofhighefficacyorhavenoneavailabletothemandhaverecentlypresentedevidenceofinflammatoryCNSdiseaseactivity;andwhocouldundergoAHSCTwithanacceptableestimatedlevelofriskofadverseevents.JustificationforeachofcriteriaissupportedbyevidencefromAHSCTtrialsandobservationalstudies.

Referralcriteria:

I. DiagnosisofMSmadebyaneurologistII. Abletowalk,needingatmostbilateralassistancetowalk20mtwithoutrestingIII. InrelapsingMS(RMS),failedonelicenseddiseasemodifyingdrugofhighefficacy

(currentlyincludingalemtuzumabandnatalizumab)becauseofdemonstratedlackofefficacy

IV. NewMRIactivitywithinlast12months

Inclusioncriteria:

1. Age18to65years2. Diseaseduration≤15yearsfromdiagnosisofMS3. DiagnosisofMSaccordingtoMcDonald’scriteria4. ForPPMS,CSFOCB+5. ForRMS,failedatleastonelicenseddiseasemodifyingdrugofhighefficacy

(‘Category2’asdefinedbyScoldingN,BarnesD,CaderS,etal.PractNeurol2015;15:273–279;currentlyincludingalemtuzumabandnatalizumab)becauseofdemonstratedlackofefficacy(asevidentfromrelapse,MRIactivityasdefinedbelowatPoint7,orEDSSincrease)afterbeingonDMTforatleast6months

6. EDSSscore0-6.57. InflammatoryactiveMSasdefinedby≥1Gd+(>3mm)lesion(offsteroidsforone

month)or≥2newT2lesionsinMRIwithinlast12months8. ApprovedbytheMDT

Exclusioncriteria:

a. EligibleforanethicallyapprovedclinicaltrialwhereAHSCTisofferedasoneofthetreatmentarms

b. UnabletoadequatelyunderstandriskandbenefitsofAHSCTandgivewritteninformedconsent

c. Priortreatmentwithtotallymphoidirradiationandautologousorallogeneichematopoieticstemcelltransplantation

Page 2: London ms hsct collaborative group patient eligibility criteria final

LondonMS-AHSCTCollaborativeGroup-PatientEligibilityCriteriaFinalV.3.–8/12/2015

d. ContraindicationtoMRIincludingbutnotlimitedtometalimplantsorfragments,historyofclaustrophobiaortheinabilityofthesubjecttoliestillontheirback

e. Poorlycontrolleddepressionorrecentsuicidalattemptf. Presenceofanyactiveorchronicinfectiong. Unabletowalk20mtwithorwithoutsupport,orwheelchairdependenth. Anysignificantorgandysfunctionorco-morbiditythattheInvestigatorsconsiderwould

putthesubjectatunacceptablerisk

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