Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Objective:

Primary Objectives:

• Screening and Reassessment (MSRP): To evaluate the feasibility of MATCHBox receiving and organizing all data needed for assignment to a myeloMATCH clinica >trial or Tier Advancement Pathway (TAP) within 72 hours of MDNet receipt of al >required specimens for initial therapy and within 10 days for subsequent therapy.
• Tier Advancement Pathway (TAP): To enable participants who are not matched to an investigational myeloMATCH treatment substudy to receive standard of care (SOC) while remaining on the MSRP to maintain access to later tiers of treatment substudies.

Secondary Objectives:

• Screening and Reassessment (MSRP)
  • To describe the time to generation of all data required for treatment substudy (or TAP) assignment, time to treatment substudy (or TAP) assignment, percent assigned to a myeloMATCH treatment substudy, and the percent of screened participants who register to a myeloMATCH investigational treatment substudy or are assigned to TAP:
    • Separately within each tier of myeloMATCH treatment substudy and analogous TAP assignment (see Section 2.1 for tier definitions)
    • Separately within each clinical basket of myeloMATCH treatment substudies (see Section 2.2 for clinical basket definitions).
    • Over time, across and within the categories above.
• Tier Advancement Pathway (TAP)
  • To evaluate participants for assignment to higher tier treatment substudies within myeloMATCH.
  • To describe, within tier- and basket- levels of TAP, measurable residual disease (MRD) rates and clonal evolution.
  • To describe, within tier- and basket- levels of TAP, remission status and overall survival of participants who receive standard of care therapy.
  • To obtain MDNet specimens for translational medicine and biobanking.