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A phase 3 trial of Palifermin, Cyclophosphamide and Etoposide in Leukaemia, run by Swedish Orphan Biovitrum, completed.
Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE) is a phase 3 interventional study registered as NCT00109031 by Swedish Orphan Biovitrum, with 47 participants recorded, started 2005-01 and reaching its primary completion in 2006-02. Interventions recorded: palifermin, Total Body Irradiation, Cyclophosphamide, Etoposide, Placebo. Conditions recorded: Cancer, Lymphoma, Leukemia.
Linked to the drug Palifermin because the registry names it among its interventions and Leukaemia among its conditions. Registry record only: no result has been read by an editor.
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.
47 enrolled.
Figures from the ClinicalTrials.gov results section (first posted 2014-09-15), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4), Yesprimary | Palifermin 60 µg/kg for 3 Days | 11 | 9 participants | - | - | link |
| Palifermin 180 μg/kg on Day -1 | 10 | 6 participants | ||||
| Palifermin 180 μg/kg on Day -2 | 13 | 4 participants | ||||
| Palifermin 180 μg/kg on Day -3 | 12 | 9 participants |
Shares Palifermin, Sobi (Swedish Orphan Biovitrum) and the tag pipeline.
Shares Palifermin, Sobi (Swedish Orphan Biovitrum) and the tag pipeline.
Shares Sobi (Swedish Orphan Biovitrum) and the tag pipeline.
Shares Etoposide, Leukaemia (all types), Cyclophosphamide and the tag pipeline.
Shares Leukaemia (all types), Cyclophosphamide and the tag pipeline.
Shares Etoposide, Leukaemia (all types), Cyclophosphamide and the tag pipeline.
Shares Etoposide, Leukaemia (all types), Cyclophosphamide and the tag pipeline.
Shares Etoposide, Leukaemia (all types), Cyclophosphamide and the tag pipeline.