# Study 0201

Source: https://onco.cc/trials/study-0201/  
OnCo record `study-0201` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: 0201; MAXIM-MP-MA-0201; CWRU-MAXI-1998; Ceplene pivotal trial
- Registry id: NCT00003991
- Phase: 3
- Setting: Adults with acute myeloid leukaemia in first or subsequent complete remission after consolidation: histamine dihydrochloride plus low-dose interleukin-2 against no further therapy
- Sponsor: Maxim Pharmaceuticals
- Enrolled: 320
- Result: Leukaemia-free survival improved over observation in the full population (n=320, P<.01); in first complete remission, 3-year leukaemia-free survival 40% with histamine plus interleukin-2 against 26% with observation (P=.01).
- Outcomes: Leukaemia-free survival at 3 years, first complete remission subgroup: Histamine dihydrochloride plus interleukin-2 40% vs No further therapy (observation) 26%

## Sources

- ClinicalTrials.gov NCT00003991: https://clinicaltrials.gov/study/NCT00003991
- Blood 2006: https://doi.org/10.1182/blood-2005-10-4073
- Ceplene EPAR (EMA): https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- technologies: [Cytokines & engineered cytokines](https://onco.cc/technologies/cytokine-therapy/)
- drugs: [Aldesleukin (high-dose IL-2)](https://onco.cc/drugs/aldesleukin/), [Histamine dihydrochloride](https://onco.cc/drugs/histamine-dihydrochloride/)
- key papers: [Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial](https://onco.cc/key-papers/paper-study-0201-blood-2006/)

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