Lenalidomide (L) induces high response rates with molecular remission in patients (pts) with relapsed (rel) or refractory (ref) chronic lymphocytic leukemia (CLL)
Bibliographic record
Abstract
6517 Background: Tumor microenvironment (ME) is critical in CLL pathogenesis. Targeting the ME is a novel approach in CLL therapeutics. Lenalidomide (Revlimid, L) is an immunomodulating agent (IMiD), approved for pts with transfusion-dependent low or intermediate-1 risk myelodysplastic syndrome with deletion 5q cytogenetic abnormality. Its antitumor activity is possibly mediated through (a) downregulation of cytokine(s) - TNF-α, VEGF, PDGF and IL-6 and/or (b) activation of immune effector cells (T & NK cells). We investigated its antitumor activity in rel/ref CLL pts. Here we present the final results of the first cohort of pts treated with 25mg daily dose of L. Methods: Oral L was given at 25mg/day for 21 out of a 28 day cycle. Anti-leukemic effects were recorded after each cycle using NCI-WG 1996 criteria. Treatment was continued until molecular complete response (mCR) or progressive disease (PD). Those with PD were then treated with L in combination with rituximab (reported separately). Polymerase chain reaction (PCR) for immunoglobulin heavy chain gene was used to determine molecular remission (mCR). Results: Twenty-nine pts (median age 64 years; range: 47–75) have been enrolled. Toxicity is reported on all, while response on 19 evaluable pts. Nine pts are inevaluable (2 withdrew consent and 5 received < 2 months of therapy due to toxicity). Major response was noted in 13 of 19 evaluable pts (68%) with 3 CR (2 mCR) and 10 PR. Toxicity: Most common grade 3/4 adverse effects (AE) were neutropenia (60%) and thrombocytopenia (55%). Another common AE was tumor flare (79%); characterized by tender swelling of lymph nodes and/or rash, noted in almost all pts. Conclusions: L at 25mg/day dose given on days 1–21 in a 28 day cycle yields high ORR including mCR in rel/ref CLL. Hematologic toxicity was the most common AE requiring dose reduction. Overall safety profile was predictable and manageable. A slow dose escalation schema, starting at 15mg is being investigated. [Table: see text]
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".