First results of a phase 2 study using a 10-day subcutaneous (SC) regimen of the novel hypomethylating agent (HMA) SGI-110 for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML).
Bibliographic record
Abstract
7030 Background: SGI-110 is a novel HMA administered as a small volume injection which results in extended decitabine exposure. We previously reported an Overall Complete Remission (OCR=CR+CRi+CRp) rate of 16% in 50 patients with r/r AML using SGI-110 daily x 5 regimen with either 60 or 90 mg/m2/d (Kantarjian et al, 2013). We report here the first results of the daily x 10 Q 28 days regimen using 60 mg/m2/d. Methods: Patients with AML who relapsed or progressed following prior treatment were enrolled. There was no limit on the number of prior treatment regimens, total WBC, or blast %. The primary endpoint was OCR using modified IWG 2003 criteria. Secondary efficacy endpoints included duration of response, and Overall Survival. Safety was assessed using the CTCAE Version 4. After 2-4 cycles, investigators were allowed to consolidate with daily x 5 at 60 mg/m2/d regimen until progression. Results: The study completed enrolment with 53 patients treated. Patients had a median age of 57 years (range 29-82), 51% were male, 83% had ECOG PS of 0-1, and 17% had ECOG PS 2. Median number of prior regimens was 2 (range 1-7); 13% of patients had prior HMA treatment. The primary efficacy endpoint of OCR was reported in 16 patients (7 CR, 6 CRi, and 3 CRp) or an OCR rate of 30% (95% CI: 18.3%, 44.3%). Seven patients are still on treatment. 30-day and 60-day mortality were 1.9% and 11.3% respectively. Of 162 total number of cycles given at the data cutoff, 149 (92%) were given using the 10-day regimen and 13 (8%) were given using the daily x 5 consolidation. The most common drug-related Grade ≥3 AEs were: anaemia and thrombocytopenia (19% each), neutropenia and febrile neutropenia (5.7% each). Conclusions: SGI-110 given as a daily x 10 SC regimen at a dose of 60 mg/m2/d was clinically active in heavily pretreated population of r/r AML with an acceptable safety profile. The results appear to compare favorably with our previously reported complete remission response rate in a similar patient population using the daily x 5 regimen at doses of 60 or 90 mg/m2/d. These results warrant further investigation of this regimen for the treatment of r/r AML. Clinical trial information: NCT01261312.
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".