MYELOMATCH, Master Screening and Reassessment Protocol for Tier Advancement in the NCI myeloMATCH Clinical Trials
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: Haddadin, Michael
Contact Information:
Stephanie Parker
steparker@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05564390?term=NCT05564390&rank=1#participation-criteria
Summary
PRIMARY OBJIECTIVES:
a. Screening and Reassessment (MYELOMATCH: To evaluate the feasibility of MATCHBox organizing all specimen testing results needed for assignment to a myeloMATCH clinical trial or Tier Advancement Pathway (TAP) by one hour prior to the first Treatment Verification Call held 4 days after MDNet (Molecular Diagnostic Network) receipt of all required specimens for initial therapy and by 11 days for subsequent therapies.
b. 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 MYELOMATCH to maintain access to later tiers of treatment substudies.
SECONDARY OBJECTIVES:
a. Screening and Reassessment (MYELOMATCH)
1. To describe the time to MDNet generation of all specimen testing results 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:
a. Separately within each tier of myeloMATCH treatment substudy and analogous TAP assignment (see Section 2.1 for tier definitions)
b. Separately within each clinical basket of myeloMATCH treatment substudies (see Section 2.2 for clinical basket definitions).
c. Over time, across and within the categories above.
b. Tier Advancement Pathway (TAP)
1. To evaluate participants for assignment to higher tier treatment substudies within myeloMATCH.
2. To describe, within tier- and basket- levels of TAP, measurable residual disease (MRD) rates and clonal evolution.
3. To describe, within tier- and basket- levels of TAP, remission status and overall survival of participants who receive standard of care therapy.
4. To obtain MDNet specimens for translational medicine and biobanking.