TriangleNCT02048813 · OUTCOME
The Association Between Baseline Rai Stage and Complete Response (CR) Rate
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 at baseline, every 3 months for the first 2 years, and every 6 months for years 3-5
What was measured
Patients are classified as stage 0-IV according to the Rai system and categorized into one of the three risk groups: Low risk - Stage 0 Intermediate risk - Stage I or II High risk - Stage III or IV CR requires all of the following for at least 2 months: * Absence of lymphadenopathy by physical examination on 2 occasions at least 4 weeks apart and appropriate radiographic techniques. For patients whose only measurable disease at the time of enrollment is on CT scan, a CT scan is required and all lymph nodes must be ≤ 1.5 cm before classifying the patient a CR. * Absence of hepatomegaly or splenomegaly by physical examination * Absence of constitutional symptoms due to disease * Normal complete blood count * One marrow aspirate and biopsy should be performed 52 weeks after Day 1 of cycle 1 among patients with clinical and laboratory evidence of a CR to document a CR. The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes.
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
- Patients are classified as stage 0-IV according to the Rai system and categorized into one of the three risk groups: Low risk - Stage 0 Intermediate risk - Stage I or II High risk - Stage III or IV CR requires all of the following for at least 2 months: * Absence of lymphadenopathy by physical examination on 2 occasions at least 4 weeks apart and appropriate radiographic techniques. For patients whose only measurable disease at the time of enrollment is on CT scan, a CT scan is required and all lymph nodes must be ≤ 1.5 cm before classifying the patient a CR. * Absence of hepatomegaly or splenomegaly by physical examination * Absence of constitutional symptoms due to disease * Normal complete blood count * One marrow aspirate and biopsy should be performed 52 weeks after Day 1 of cycle 1 among patients with clinical and laboratory evidence of a CR to document a CR. The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes.
- reporting Status
- NOT_POSTED
- time Frame
- Assessed at baseline, every 3 months for the first 2 years, and every 6 months for years 3-5
- title
- The Association Between Baseline Rai Stage and Complete Response (CR) Rate
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice