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PRIMA Investigator Meeting. Friday, June 16, 2006 Grand Sofitel Demeure , Amsterdam Stéphanie Baulu, Delphine Germain & Gilles Salles. Agenda. Status of the study Regulatory issues Flow of CRFs and queries Flow of SAEs Medical questions Financial aspects Other questions ?. STATUS.

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PRIMA Investigator Meeting

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Prima investigator meeting

PRIMAInvestigator Meeting

Friday, June 16, 2006

Grand Sofitel Demeure, Amsterdam

Stéphanie Baulu, Delphine Germain & Gilles Salles


Agenda

Agenda

  • Status of the study

  • Regulatory issues

  • Flow of CRFs and queries

  • Flow of SAEs

  • Medical questions

  • Financial aspects

  • Other questions ?


Status

STATUS

  • 25 countries in Prima Study

  • 23 active countries (at least 1 patient)

  • 740 patients registered (13/06/06)

  • 270 patients randomized (13/06/06)


Prima recruitment

PRIMA RECRUITMENT


Prima recruitment1

PRIMA RECRUITMENT


Prima recruitment2

PRIMA RECRUITMENT

Chemo regimen chosen

R-CHOP54773%

R-CVP16722%

R-FCM 31 4%

Recent increase in R-CVP treated patients


Regulatory aspects

Regulatory Aspects

  • To be provided to GELARC :

    • CV of Principal Investigator in each center

    • Approvals (Ethics Committee and Health Authorities) for amendment n°2 + regulatory certification document

  • Insurance extension (OK for all countries)

  • After reception of approvals, PI of each center will sign an Amendment form


Crfs flow chart

CRFs FLOW CHART

  • Baseline part (p1 to 9) => sent to GELARC before randomization

  • Induction / randomization parts (p10 to 18) => sent as soon as possible

  • Maintenance part => every 4 visits (with evaluation and toxicity pages)

  • Progression, events, deaths : as soon as possible

  • AE and original forms of SAE => sent after each monitoring visit

    Remember that all parts have to be monitored

    before sending them to GELARC


Query data management

QUERY & DATA MANAGEMENT

  • CRFs validation

    • parametered tests + medical review

  • CRFs are validated as follow :

    • Baseline + induction treatment

    • Maintenance (every 4 visits)

    • Follow-up / progression / death / AEs (at reception)

  • Clinical data correction Forms will be sent by GELARC after the validation of each part


  • Query data management1

    QUERY & DATA MANAGEMENT

    • Clinical data correction Forms will be sent by e-mail to the local coordinator (study group, Roche or other)

    • Answers must be completed directly on the form by the investigator (do not forget to sign and date form ! )

    • One copy must be kept in the CRF

    • Each completed form has to be faxed to GELARC (ASAP) and original forms have to be sent after the next monitoring visit (with CRF pages)


    Clinical data correction form

    Clinical data correction form

    Identification of Patient and center

    Question

    Your answer

    CRF Page (s)

    Proposal for answer

    Actual Data reported on CRF

    Item concerned by query

    Name and signature of investigator


    Serious adverse events

    Serious Adverse Events

    • 172 SAEs recorded

    • Record medical diagnosis and not a list of symptoms

    • Do not forget to send follow-up if necessary

    • Queries on SAE are sent directly to the center by fax => answer in the same way (write answer on the Query form)


    Some clinical aspects inclusion criteria 1

    Some clinical aspects“inclusion criteria” (1)

    • Please note than those have to be fulfilled

    • Remember:

      • Diagnosis on LYMPH NODE biopsy

      • Steroids during the last 4 weeks < 20 mg/day equivalents

      • Stage I/II should have a high tumor burden

      • Spleen is always > 7 cm and is not a bulk criteria by itself !!

      • Issues with hepatitis (HIV)

    • Don’t hesitate to ask… [email protected]


    Some clinical aspects randomization 1

    Some clinical aspects“randomization” (1)

    • Inclusion criteria should be met !

    • The inclusion data should be sent to GELA-RC

    • Treatment has to follow the initial protocol schemes : doses and schedules

    • Only CR and PR patients randomized

    • Why are they only 14 days day tolerated ?


    Some clinical aspects maintenance or observation

    Some clinical aspects“maintenance or observation”

    1) Please follow the protocol recommendations for

    - visits every 8 weeks

    - CT scans every 6 months

    2) Please indicate any event/progression as soon as it occurs


    The future of prima

    The future of PRIMA

    • With more than 730 pts recruited, PRIMA is already the largest trial ever performed in first line follicular lymphoma patients

    • Rhythm of inclusion extremely high allowed to extend the population from 640 to 900 pts (675 pts randomized)

    • An opportunity for answering a very important question with a high standard quality trial :

      • Rituximab maintenance benefit after R-chemo


    Prima investigator meeting

    Thanks to all of you

    for your cooperation


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