Study 0201
Study 0201 showed that histamine injections given with low-dose interleukin-2 after consolidation helped more adults with acute myeloid leukaemia in first remission stay free of leukaemia at three years than observation alone, and it was the main evidence for the EU authorisation of Ceplene.
Overview
Study 0201 was a multicentre, randomised, open-label phase 3 trial of post-consolidation immunotherapy with histamine dihydrochloride plus interleukin-2 in adults with acute myeloid leukaemia in complete remission. Three hundred and twenty patients (median age 57 years, range 18 to 84) were stratified by first complete remission or subsequent remission and assigned to histamine dihydrochloride 0.5 mg plus interleukin-2 16,400 units per kilogram, both injected under the skin twice daily for ten 21-day cycles, or to no further therapy. Study arms were balanced for age, sex, previous treatment, karyotype, time from remission to inclusion and secondary leukaemia.
Three years after the last patient was enrolled, leukaemia-free survival was better with histamine plus interleukin-2 than with observation in the full population (n = 320, P less than .01, log-rank). In first complete remission (n = 261), three-year leukaemia-free survival was 40 percent with the combination against 26 percent with observation (P = .01). Side effects were typically mild to moderate (Blood 2006).
The EMA overview describes one main study of 320 adults with acute myeloid leukaemia in remission, in which Ceplene with interleukin-2 was compared with no treatment. The European Commission authorised Ceplene on 7 October 2008 under exceptional circumstances for maintenance with interleukin-2 in adults in first remission; the marketing authorisation holder is Laboratoires Delbert. The registry records the study as completed under secondary id MAXIM-MP-MA-0201 and posts no results.
- 40 vs 26 out of 100 had no sign of cancer on scans or tests with Histamine dihydrochloride plus interleukin-2 compared with No further therapy (observation); 14 more per 100.
- Roughly one extra person helped for every 7 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.01) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Adults with acute myeloid leukaemia in first or subsequent complete remission after consolidation: histamine dihydrochloride plus low-dose interleukin-2 against no further therapy. People in a different situation may not see the same effect.
- First-remission subgroup (n = 261 across both arms); the primary analysis in all 320 patients reported P < .01 without printed rates.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
320 randomised.
First-remission subgroup (n = 261 across both arms); the primary analysis in all 320 patients reported P < .01 without printed rates
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Leukaemia-free survival at 3 years, first complete remission subgroup | Histamine dihydrochloride plus interleukin-2 | - | 40% | - | 0.01 | link |
| No further therapy (observation) | - | 26% |
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