Clinical trial · Interventional
Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis
Subcutaneous Cladribine Plus Pegylated Interpheron Alfa-2a in Advanced Systemic Mastocytosis With D816V and Other Exon 17 KIT Mutations.
NCT01602939CI-TRIAL-00023691unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Systemic Mastocytosis | Systemic Mastocytosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cladribine and pegylated interpheron alpha-2a | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 2CDA+IFN
- interventionNames
- Drug: Cladribine and pegylated interpheron alpha-2a
Primary outcomes (1)
- measure
- To evaluate the effect of therapy on bone marrow mast cell infiltration.
- timeFrame
- 6 months
- description
- Evaluation of bone marrow response will be assessed by immunohistochemestry, citology, flow cytometry and molecular analyses of bone marrow samples.
Secondary outcomes (6)
- measure
- To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis.
- timeFrame
- 6 months
- description
- Serum tryptase and any other mastocytosis-related altered biochemical parameter at diagnosis will be measured monthly until the end of therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age older than 18 years. * Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations. * ECOG ≤ 3. * Signed informed consent. Exclusion Criteria: * Impaired liver function (total bilirubin ≥ 2.0 mg/dl, AST or ALT \> 3 x upper limit of normal)not related to mastocytosis. * Impaired renal function (≥ 2.0 mg/dL)not related to mastocytosis. * Grade III-IV cytopenias not related to mastocytosis. Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction \< 50%). * Pregnancy or breastfeeding. * Female patients who do not use contraceptive methods.
References
Publications (0)
Data not yet available
No reference posted for this study.