IMPROVED OUTCOMES IN PATIENTS (PTS) WITH BCL2‐POSITIVE DIFFUSE LARGE B‐CELL LYMPHOMA (DLBCL) TREATED WITH VENETOCLAX (VEN) PLUS R‐CHOP: RESULTS FROM THE PHASE 2 CAVALLI STUDY
Bibliographic record
Abstract
Results: As of 21 Feb 2019, 20 pts have been treated.Median age: 63 yrs (range 50-77), 33% del(17p), 43% complex karyotype, and 29% and 10% TP53 and NOTCH1 mutation, respectively.Median # prior CLL treatments 2 (range 0-5, prior ibrutinib (n=8), idelalisib (n=2), and ven (n=2); 5 pts no prior treatment).Median # ven + da-R-EPOCH cycles in this ongoing study is 3.5 (range 1-6), including 5 pts who recently enrolled.4 pts had dose de-escalation of R-EPOCH and 1 pt had dose escalation.≥Gr 3 heme toxicity included: neutropenia (45%), anemia (35%), thrombocytopenia (25%).≥Gr 3 non-heme toxicities in ≥15% of pts: febrile neutropenia (20%), hypocalcemia and hypophosphatemia (15% each).No TLS occurred with daily ven ramp-up after 1 cycle of R-EPOCH.Infectious complications: 3 pts with sepsis during C1 of R-EPOCH (prior to starting ven) and 1 pt each with influenza A and norovirus while on combination therapy.7 pts died, including 4 due to disease progression (2 during C1 before ven), and 1 each due to sepsis, sudden death, and GVHD post-alloHCT.8 pts are not evaluable for efficacy of the combination (3 are still in C1, 4 had toxicity in C1 and never started ven, 1 pt withdrew in C1).Of the 12 evaluable pts who have started combination therapy, 9 responded (ORR 75%); 8/12 (67%) had CR, all of whom also had undetectable bone marrow MRD for CLL. 5 pts went to alloHCT, with pts still in CR now up to 1.5 yrs post-alloHCT.With a median followup of 3 mo (range 0-17.9),median PFS is 10 mo (Fig 1A), median OS is 16.3 mo (Fig 1B).Conclusions: Our initial data suggest that ven + da-R-EPOCH is a feasible regimen to treat RS.Expected toxicities from intensive chemoimmunotherapy were seen, without significant additional toxicity from ven, including no TLS with daily ven ramp-up.The 67% CR and PFS/OS of 10/16.3mo are favorable in the context of historical results.Accrual is ongoing, and updated results will be presented.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".