Patient MHRA MREC updated approval · Yes 02 Feb 10 29 Jan10 11 Introduction of sapacitabine into...
1
EUDRACT: 2005-002847-14 SPONSOR Code : CU106 Main REC Ref No: 05/MRE09/84 Page 1 of 1 Amendment Detail Patient information updated MHRA approval MREC approval Approval 19 Sep 05 16 Dec 05 1 Reduction of daily dose of Zarnestra – 600 to 300mg. No 08 Mar 06 09 Feb 06 2 Introduction of ATO, confirmation of clofarabine dose. Yes 29 Jun 06 08 Jun 06 3 Clarification re: manufacturer mylotarg. No 01 Dec 06 NR 4 Removal of Zarnestra arm, amendment to CTA Yes 14 Jan 08 25 Jan 08 5 Use of Baxter Healthcare to reconstitute IMP for some trial sites No 16 Jun 08 NR Clofarabine IB Extension of clofarabine shelf life to 3 years (from 24 months) N/A N/A N/A 6 Change of manufacturer of Azacytidine reflected on IMP label No 06 Oct 09 22 Dec 09 7 Correction of Azacytidine label No 20 Nov 09 22 Dec 09 8 Use of commercial stock of Azacytidine No 25 Nov 09 22 Dec 09 9 Administrative update including change of PI, new trial sites and correction of CTA (to reflect removal of Zarnestra, ATO) No 02 Feb 10 05 Feb 10 10 Patient information sheets updated to reflect closure of treatment options (incl. completion of clofarabine intensive) Yes 02 Feb 10 29 Jan10 11 Introduction of sapacitabine into non-intensive arm, removal of mylotarg. Confirmation of replacement of Clo with DA/ADE +/- ATRA. Yes 29 Apr 10 22 Jun 10 12 Introduction of new sites and changes to PIs No 15 Jun 10 25 Jun 10
Transcript of Patient MHRA MREC updated approval · Yes 02 Feb 10 29 Jan10 11 Introduction of sapacitabine into...
EUDRACT: 2005-002847-14 SPONSOR Code : CU106 Main REC Ref No: 05/MRE09/84
Page 1 of 1
Amendment Detail Patient
information updated
MHRA approval
MREC approval
Approval 19 Sep 05 16 Dec 05
1 Reduction of daily dose of Zarnestra – 600 to 300mg. No 08 Mar 06 09 Feb 06
2 Introduction of ATO, confirmation of clofarabine dose. Yes 29 Jun 06 08 Jun 06
3 Clarification re: manufacturer mylotarg. No 01 Dec 06 NR
4 Removal of Zarnestra arm, amendment to CTA Yes 14 Jan 08 25 Jan 08
5 Use of Baxter Healthcare to reconstitute IMP for some trial sites No 16 Jun 08 NR
Clofarabine IB
Extension of clofarabine shelf life to 3 years (from 24 months) N/A N/A N/A
6 Change of manufacturer of Azacytidine reflected on IMP label No 06 Oct 09 22 Dec 09
7 Correction of Azacytidine label No 20 Nov 09 22 Dec 09
8 Use of commercial stock of Azacytidine No 25 Nov 09 22 Dec 09
9 Administrative update including change of PI, new trial sites and
correction of CTA (to reflect removal of Zarnestra, ATO) No 02 Feb 10 05 Feb 10
10 Patient information sheets updated to reflect closure of treatment options
(incl. completion of clofarabine intensive) Yes 02 Feb 10 29 Jan10
11 Introduction of sapacitabine into non- intensive arm, removal of mylotarg. Confirmation of replacement of Clo with DA/ADE +/- ATRA. Yes 29 Apr 10 22 Jun 10
12 Introduction of new sites and changes to PIs No 15 Jun 10 25 Jun 10
