What dose modifications are allowed. Define a successful surgery. If autologous, when collected, how purged, when reinjected, what rescue samples are taken. If allogenic, which donor, matching criteria. Specify which treatments may not be administered while a patient is on study.
Check boxes where an action is to be taken.
If clinical response is an endpoint, specify what constitutes a complete response, a partial response, stable disease and progressive disease. For quality of life and other questionnaires, provide copies in the appendix. References to validation studies for these instruments are also appropriate. If appropriate, describe how many patients will be studied, at what times samples are to be drawn. Toxicities Review the major toxicities of each treatment component.