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HUMAN ETHICS COMMITTEE

October 12, 2010

To,Or. Manju Sengar,Principal Investigator,TMH.

Ref: Final Approval -Project No. 816

Dear Dr. Sengar,

Human Ethics Committee-I reviewed and discussed your application dated 24.08.2010 to conduct theresearch study entitled "Protocol OMB112517: A phase Ill, open label, randomized, multicenter trialof ofatumumab maintenance treatment versus no further treatment in subjects with relapsedchronic lymphocytic leukemia (eLL) who have responded to induction therapy" during the HEC-Imeeting held on 28.09.2010 at 8.30 a.m. in the Institutional Review Board Meeting Room, MainBldg., 3rd Floor, lata Memorial Hospital.

The following documents were reviewed:

1. Project Submission form2. TMC-Scientific Review Committee approval dated 03.09.20103. Protocol no. UM2008/00446/02 version no. Amendment NO.1dtd. 20-Nov-20094. Investigator's Brochure for GSK1841157 (Ofatumumab) version 3 dtd. 28-Apr-20105. Investigational New Drug Safety Reports and for Ofatumumab (Issued from IB cut-off date 21-

Jan-2010) dtd. 21-Jan-201 0 to 02-Jul-201 06. Periodic Safety Reports for Ofatumumab dtd. 1-Nov-2009 to 31-Jan-201 0 and 1-Feb-2010 to

30-Apr-2010• Blinded• Unblinded

7. Annotated e-Case Record Form Workbook dtd. 16-Dec-20098. DCGI Submission Letter dtd. 1-Jun-20109. Subject Questionnaire Booklets: English, Hindi, Marathi dtd. 26-0ct-200910. Screening11. Post-Screening12. Patient Emergency Cards

• English dtd. 17-Mar-2005• Hindi dtd. 30-Jan-2007• Marathi dtd. 8-Feb-2007

13. Clinical Trial Compensation Guidelines: English, Hindi, Marathi14. Bajaj Allianz Insurance15. Investigator Undertaking to DCGI and Confirmation of Participation to DCGI16. Draft Clinical Trial Agreement (Tripartite)17. Brief CV

Final approval for project No. 816 of 4 3WI3lR <ft 31'i'tlim;sf. {. ~ "Wf. ~

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IRB Of1iceDr. E. Barges Marg. Parel,Mumbai - 400 012. IndiaPhone: 022-2417 7262Fax:022-22 2414 6937

Cancer is curable, if detected early

E-mail: [email protected] : http://tmc.gov.in

• Principal Investigator - Or. Manju Sengar• Sub-Investigators - Or. Reena Nair, Or. Navin Khattry, Or. Hari Menon, Or. P. G.

Subramaniam and Dr. Meenakshi Thakur18. Written Informed Consent Form for OMB112517 - English version 02.0HMH dtd. 26-Jan-201019. Translation of Written Informed Consent Form for OMB112517 - Hindi version 02.0HMH dtd.

26-Jan-201020. Back translation of Written Informed Consent Form for OMB112517 - Hindi version 02.0HMH

dtd. 26-Jan-201021. Translation of Written Informed Consent Form for OMB112517 - Marathi version 02.0HMH dtd.

26-Jan-201022. Back translation of Written Informed Consent Form for OMB112517 - Marathi version 02.0HMH

dtd. 26-Jan-201023. Translation and Back translation Certificates for ICFs version 02.01 TMH dtd. 13.07.2010

• Hindi• Marathi

24. OCGI Approval Letter dated 13 July 201025. T-License (T-6006/10) for Import of Orugs dated 13 July 201026. No Objection Letter to the Export of Biological Samples dated 13 July 201027. The INOSRs for Ofatumumab from the safety data review cut-off date (21-Jan-1 0) of the IB

version 03 to 2-Jul-1 0 have been listed below:

INDSR No. Date of IssueZOO04377A 2-Jul-10ZOO01791B 2-Jul-10ZOO03492A 1-Jul-10ZOOO3698A 1-Jul-10ZOO04426A 28-Jun-10ZOO04338A 24-Jun-10ZOO04317D 24-Jun-10ZOO04275B 21-Jun-10ZOO04426A 17-Jun-10ZOO04538A 17-Jun-10ZOO04426A 4-Jun-10ZOOO3880C 4-Jun-10ZOOO4210A 4-Jun-10A0861546A 3-Jun-10ZOOO4377A 3-Jun-10ZOO03878C 28-May-10ZOO04338A 28-May-10ZOO04316B 28-May-10A0860868A 28-May-10

INDSR No. Date of IssueA0810645B 28-May-10ZOO03880B 27-May-10ZOOO1332C 21-May-10ZOOO4210A 21-May-10ZOO04195A 20-May-10ZOO04137A 14-May-10ZOOO3996A 14-May-10ZOO04015A 6-May-10ZOO03103B 6-May-10ZOO03492A 4-May-10ZOO03996A 30-Apr-10B0646491A 27-Apr-10ZOO03878A 22-Apr-10ZOOO2985B 20-Apr-10ZOOO3827A 16-Apr-10B0646491A 16-Apr-10ZOOO2414C 15-Apr-10B0646491A 15-Apr-10ZOO02985B 9-Apr-10

Final approval for project No. 816 of 4

INDSR No. Date of IssueZOOO3533A 9-Apr-10ZOOO0796B 9-Apr-10ZOOO3711A 1-Apr-10ZOOO3698A 1-Apr-10ZOO02985B 1-Apr-10ZOOO0538B 31-Mar-10ZOOO3362A 18-Mar-10ZOOO3533A 16-Mar-10B0594234B 16-Mar-10A0690657C 11-Mar-10ZOO03362A 5-Mar-10A0807803A 26-Feb-10ZOO02985A 11-Feb-10ZOOO2985A 29-Jan-10ZOO02834A 29-Jan-10ZOOO0903A 29-Jan-10ZOO02675A 28-Jan-10A0810645B 28-Jan-10

The following members of the Human Ethics committee-I (HEC-I) were present at the meeting held on28.09.2010 at 8.30 a.m. in the Institutional Review Board Meeting Room, Main Bldg., 3rd Floor, TataMemorial Hospital.

Sr. Names Affiliation Gender ExpertiseNo.

1. Dr. Madhuri Gore Professor & Head, Dept. of Surgery, Female SurgeonChairperson LGMT Hospital, Sion

2. Or. R.C. Mistry Surgeon, Kokilaben Dhirubhai Ambani Male SurgeonCo-Chairperson Hospital,

3. Or. J. V. Divatia Professor, Dept. of Anaesthesia, Tata Male AnaesthetistMember Secretary Memorial Centre

4. Dr. N. Gogtay, Associate Professor, Clinical Female ClinicalMember Pharmacoloqv, KEM Hospital Pharmacoloqist

5. Or. Pradnya Talawadekar, Project Manager of Ojus Medical Female Legal expertMember Institute, Juhu.

6. Ms. Viji Venkatesh, Head, Max Station India & Asia Pacific Female Lay personMember Region Co ordinator

7. Ms. Mrunal Marathe, Medical Counselor Female Social scientistMember

8. Dr. S. K. Shrivastava, Head, Dept. of Radiation Oncology and Male RadiationMember Secretary, TMC Scientific Review Oncologist

Committee.9. Dr. Rakesh Jalali, Associate Professor, Dept. of Radiation Male Radiation

Member Oncology, TMH Oncologist10. Or. S. N. Myatra, Associate Professor, Dept. of Female Anaesthetist

Member Anesthesia , TMH, Jt. Secretary,OSMSC, TMH

The study is approved in its presented form. The approval is valid until one year from the date ofsanction. You may make a written request for renewal! extension of the validity, along with thesubmission of annual status report. The study should be initiated only after submission offinalized CTA to HEC.

Following points must be noted:

1. HEC should be informed of the yearly progress of the study.

2. HEC has approved recruitment of 5 participants on this study

3. PI and other investigators should co-operate fully with data and safety monitoring sub-committee (DSMSC), who will monitor the trial from time to time.

4. The decision was arrived at through consensus. Neither PI nor any of proposed study teammembers was present during the decision making of the HEC.


5. At the time of PI's retirement/intention to leave the institute, study responsibility should betransferred to colleague after obtaining clearance from HOD, Status report, including accountsdetails should be submitted to HOD, DSMSC and extramural sponsors.

6. The HEC functions in accordance with the ICH-GCP/ICMR/Schedule Y guidelines.

7. In case of any new information or any SAE, which could affect any study, must be informed toHEC, DSMSC and sponsors. The PI should report SAEs occurred for HEC approved studieswithin 7 days of the occurrence of the SAE. If the SAE is 'Death', the IRB Secretariat willreceive the SAE reporting form within 24 hours of the occurrence.

8. In the events of any protocol amendments, HEC must be informed and the amendmentsshould be highlighted in clear terms as follows:

a. The exact alteration/amendment should be specified and indicated where theamendment occurred in the original project. (Page no. Clause no. etc.)

b. Alteration in the budgetary status should be clearly indicated and the revised budgetform should be submitted

c. If the amendments require a change in the consent form, the copy of revised ConsentForm should be submitted to Ethics Committee for approval.

d. If the amendment demands a re-look at the toxicity or side effects to patients, thesame should be documented.

e. If there are any amendments in the trial design, these must be incorporated in theprotocol, and other study documents. These revised documents should be submittedfor approval of the SRC and HEC, only then can they be implemented.

f. Approval for amendment changes must be obtained prior to implementation ofchanges. Without including all the above points, the amendment is unlikely to beapproved by the Ethics committee.

g. Any deviation/violation/waiver in the protocol must be informed to the HEC.

Thanking You,

Yours Sincerely,

,1j.(Cr/D.D. Divatia,Member Secretary,Human Ethics Committee-I


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