Canadian pilot trial of haplo-identical donor transplantation
Bibliographic record
Abstract
Background: CBMTG multi-centre pilot study of haplo-identical donor BMT. AIMS: To assess 1. Ability to collect suitable graft (CD34+ ≥ 5 x 106/kg and CD3 <1 x 105/kg recipient body weight), 2. Toxicity, 3. Survival to day +100. Eligibility: All diagnoses and ages; accrual to end after 20 patients with AML in remission and age less than 55 years. Methods: Modified Perugia regimen, chemotherapy alone; melphalan 140 mg/m2 d -9, thiotepa 10 mg/kg day -7, fludarabine 40 mg/m2days -7 to -3, and ATG (Thymoglobulin, Sangstat) days -6 to -2 (total 10.5 mg/kg). Ganciclovir (GC) 5 mg/kg days 5–20 then x5/week until day +100 then x3/week until 210 (subjects 1–3), foscarnet (FC)90 mg/kg days 4–21 then short course pre-emptive GC or FC (subjects 4–11); fluconazole; cotrimoxazole. G-CSF 16 μg/kg daily x 5 until second pheresis day. CliniMACS (MiltenyiBiotec). RESULTS: Eleven (11) patients with AML have been transplanted from 4 centres, 8 female, 3 male, mean age 39 (range 19–60). Disease status, first CR 1/11, second CR 4/11, third CR1/11, relapse 5/11. Graft CD34+ ≥ 5 x 106/kg was achieved in all cases, median 13.72 x 106/kg (Q1, Q3: 8.92, 16.61; min 5.59, max 22.2), and CD3+ was <1 x 105/kg in all cases, median of 0.49 x104/kg (Q1, Q3: 0.33, 1.64; min 0.22, max 4.10). Ten (10) of the 11 patients have died, median survival 109 days (Q1, Q3: 67, 153; min 0, max > 841). Survival to day +100 6/11 (55%). Four (4) patients died of leukemic relapse, 6 of infection. Of 6 patients dying of infection, CMV was a definite cause in 4. Of 4 dying with relapse, CMV was significant in 1 and asymptomatic in another. Engraftment was assessed in 10 patients who survived >0 days. Granulocyte engraftment (>0.5 x 109/L) achieved in all patients, median 12 days (Q1, Q3: 11, 16; min 8, max 70). Platelet engraftment (>20 x 109/L) achieved in 8 of 10 patients, median of 18 days (Q1, Q3: 14, 37; min 9, max 97). The two platelet non-engrafters died on days + 45 and +61. Toxicity was low, with one toxic death (day 0), and the Bearman organ toxicity gradings were < grade 2 in all other patients. Conclusions: Haplo-identical transplantation is feasible, with a high engraftment rate, minimal toxicity and minimal risk of graft versus host disease and rejection. However, relapse and CMV infection were frequent complications in this ultra-high risk group of patients. Physicians have been reluctant to refer earlier.
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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) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".