Table 2.

Phase I trials for lymphomas

Recommendations
Methods of dose escalation
  • –CRM may be used in phase I trials as it can accelerate dose escalation and eliminate subtherapeutic doses faster

  • –CRM may also be used in two drug combinations that require exploration of the dose of both drugs

  • –Registered drugs in combinations can be used at their standard dose and increase only the dose of the experimental drug; a 3+3 design can be used in these trials

Patients' selection
  • –Efforts should be made to define molecular subsets of patients most likely to benefit from MTAs

Evaluation of late-onset toxicities
  • –Statistical models may be helpful, but they need to be evaluated via simulated trials before implementing them in future clinical trials

Response rate
  • –A threshold of 30% response rate in unselected patients is a desirable minimum requirement of activity of single agent before moving to phase II trials

  • –Agents with lower response rate may still guarantee further development if a biomarker is available or in drug combinations

  • Abbreviations: CRM, Continual Reassessment Method; MTAs, molecularly targeted agents.