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Leucovorin for Folotyn-Induced Mucositis in PTCL/CTCL
NCT02106650Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2014
- Primary completion
- Oct 2018
- Countries
- 1
- Sponsor
- Acrotech Biopharma Inc
- Modality
- Orthosteric Ligands
- Drugs
- folinic acid
- Conditions
- oral mucositis (OM)
01
Overview
Phase 2, open-label, single-arm trial of folinic acid in oral mucositis (OM), sponsored by Acrotech Biopharma Inc. Primary endpoint: Grade 2 Oral Mucositis Prevention at 15 weeks. Started Jul 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Folotyn and Leucovorin
Pralatrexate (Folotyn) + Leucovorin rescue
03
Who it enrols
Adult patients with relapsed/refractory PTCL or CTCL, ECOG 0-2, adequate organ function, and no active CNS metastases or uncontrolled infections.
04
Endpoints
Primary
Grade 2 Oral Mucositis Prevention
Secondary
Grade 3 Oral Mucositis Prevention
Grade 2 Oral Mucositis Duration
Effectiveness of Leucovorin in Folotyn dose modification
Objective Response Rate
05
Results
Primary endpoints met
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