TriangleNCT02048813 · OUTCOME
Progression-free Survival (PFS) by Measurable Residual Disease (MDR) Status at 2 Years
This outcome was registered, but no numerical results were posted in the captured record.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Assessed every 3 months until progression up to 5 years
What was measured
PFS was defined as time from randomization to progression or death. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of ≥ 2 lymph nodes on 2 consecutive exams 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as progression. * Transformation to a more aggressive histology. For patients with a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \>1.5 cm by physical exam. MRD status was evaluated at 2 years and samples with \<=20 monotypic events or an MRD level of \<10\^-4 were classified as undetectable MRD.
Groups in this outcome
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denom Units Selected
- Participants
- description
- PFS was defined as time from randomization to progression or death. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of ≥ 2 lymph nodes on 2 consecutive exams 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as progression. * Transformation to a more aggressive histology. For patients with a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \>1.5 cm by physical exam. MRD status was evaluated at 2 years and samples with \<=20 monotypic events or an MRD level of \<10\^-4 were classified as undetectable MRD.
- reporting Status
- NOT_POSTED
- time Frame
- Assessed every 3 months until progression up to 5 years
- title
- Progression-free Survival (PFS) by Measurable Residual Disease (MDR) Status at 2 Years
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice