Fred Hutch # 0000.00 (Enter Fred Hutch Protocol Number)

PROTOCOL SYNOPSIS Fred Hutch # 0000.00 (enter Fred Hutch protocol number)

Current Version: 00/00/00 (enter date) Previous Version: 00/00/00 (enter date)

1. Title (If multi-center, add information about the study being a multi-center trial and specify the coordinating center.)

2. Contacts

Principal Investigator:

Person Responsible for Registration: (PI or Research Nurse)

Fred Hutch Study Coordinator:

Fred Hutch Data Coordinator: (if applicable)

3. Competing Protocols

(You Must Prioritize and State Specifically How Patients will be Allocated to Each Protocol. If Study Closes or is No Longer Valid for Your Study, Please Notify CRS at x.4520.)

4. Phase

I I/II II III IV Pilot/feasibility

5. Category (See attached definitions) 1 2 4 If this is a Category 1 or 2 Protocol then you must list all companion protocols on which this protocol depends or with which it interacts 6. Multi-Center Status

Is this protocol intended for use as a Multi-Center trial? Yes No

If Multi-Center, Please answer the following: Will Fred Hutch serve as the Coordinating Center? Yes No Are any international/Foreign institutions participating? Yes No

00321 Synopsis Template Page 1 of 7 Version: 02/28/2013 PROTOCOL SYNOPSIS Fred Hutch # 0000.00 (enter Fred Hutch protocol number)

If Fred Hutch is the coordinating Center, Please provide the names of all Participating Centers AND the name of the local Investigator (contact) at each location *:

NAME OF CENTER Name of Local Investigator International Site? (Y/N) Yes No Yes No Yes No

*IF YOUR PROTOCOL HAS MORE THAN THREE PARTICIPATING CENTERS, PLEASE USE Appendix A AT THE END OF THIS TEMPLATE TO LIST ADDITIONAL SITES.

7. Data and Safety Monitoring (excluding industry and national cooperative group studies) High Trials supporting investigator-sponsored IND’s; Phase 1 trials; gene therapy trials, NIH high risk trials Medium All other trials involving therapeutic intervention (i.e. drugs, biologics or devices) Low Trials involving non-therapeutic intervention (i.e. nutritional or behavioral trials) Exempt Non-intervention studies (such as blood draw, imaging, survey, or functional assessments) (Please see notes regarding risk level at the end of this template.) 8. DSMB Is this study monitored by a dedicated DSMB? Yes No If yes, DSMB will meet every: month(s) Subjects Other (explain):

9. Funding

Sponsor/Funding Source: Project number (if applicable):

10. Indication

11. Major Objectives

12. Study Design 00321 Synopsis Template Page 2 of 7 Version: 02/28/2013 PROTOCOL SYNOPSIS Fred Hutch # 0000.00 (enter Fred Hutch protocol number)

13. Sample size and anticipated duration

(list multi-center and consortium target totals, if applicable) Targeted enrollment* Duration of study (months) Cancer Consortium (UW, FH, SC) Total (Multicenter) *please list a specific number, not a range

Does this protocol target a specific Gender or Ethnic Group? Yes No If yes, what Gender or Ethnic group is targeted?

14. Major Eligibility Criteria

Patient Selection INCLUSIONS:

EXCLUSIONS:

Donor Selection INCLUSIONS:

EXCLUSIONS:

15. Drug Dosages and Route of Administration

16. Primary Endpoints

17. Procedures

18. Statistical Analysis

19. NCI’s Clinical Trials Reporting Program (CTRP)

Clinical trials that meet all of the following criteria will be submitted to NCI’s Clinical Trials Reporting Program (CTRP):

 Category 1 or 2 (Primary or Secondary Therapy)  Interventional  Investigator Initiated  Received SRC and IRB approval at Fred Hutch/UW Cancer Consortium  Coordinating Center of the trial is Fred Hutch or UW

Trials submitted to CTRP will be published on NCI’s comprehensive cancer website, PDQ (Physician Data Query).

Appendix A

THIS PAGE SHOULD BE COMPLETED FOR MULTI-CENTER PROTOCOLS LISTING MORE THAN THREE PARTICIPATING SITES.

Please provide the names of each Participating center AND the name of the local Investigator (contact) at each center.

NAME OF CENTER Name of Local Investigator International Site? (Y/N) Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No

Category 1: Primary Treatment Protocols These include prospective, Phase I, II, and III studies that are asking specific scientific questions and have targeted patient accruals. The questions may concern conditioning regimens for a given underlying disease; the nature of the transplant, e.g., PBSC versus marrow; adoptive immunotherapy protocols for HIV, etc.

Category 2: Posttransplantation Research Protocols These include prospective, Phase I, II, and III studies that are asking specific scientific questions and have targeted patient accruals. Questions may concern issues in infectious diseases, growth factor studies, prevention and therapy of acute and chronic GVHD, studies on growth and development, quality of life, renal disease, liver disease, gastrointestinal complications, etc.

Category 3: Standard Treatment Protocols – These protocols must be submitted to the Standard Practice Committee and IRB review is not applicable since these are treatment protocols

These will generally have evolved from Category 1 or 2 protocols and now represent state-of-the-art therapy until they are replaced by newer forms of therapy. An example is Protocol 267, Methotrexate/Cyclosporine for GVHD Prevention. There is no targeted accrual. Many patients undergoing allogeneic marrow transplantation are currently enrolled on Protocol 267. Registration of these patients on that protocol permits us to carry out large retrospective analyses, say, of risk factors for chronic GVHD among patients given MTX/CSP prevention. Also, the protocols serve educational purposes, and new fellows and residents will have an opportunity to better understand the rationale behind the standard treatment.

For more information on the approval process for category 3s, please contact the Standard Practice Committee, or Leona Holmberg, M.D., SPC Chair

Category 4: Other Protocols These would include retrospective chart reviews, retrieval of archival information in medical records or of stored samples, blood draws, volunteer studies, non-patient care studies, tissue access protocols, etc.

Fred Hutchinson Cancer Research Center Clinical Trial Monitoring Level Notes

1) Sponsor-investigator IND trials and all types of trials designated as high risk by the NIH must remain in the “High Risk” level. The risk level of other trials may be adjusted by the SRC or IRB and with the approval of both. For example, a non-intervention trial may be placed in a higher risk category if the evaluation is unusually risky or burdensome. Intervention trials will not be classified as “Exempt”.

2) Any study qualifying for “Exempt” or “Expedited Review” status for purposes of IRB review will automatically be considered as “Exempt” in the categorization for DSM review.

3) Standard of care protocols are not considered clinical trials and are not subject to classification under this system.

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