Clinical trial · Interventional
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
Phase II Study of Thalidomide in Mastocytosis
NCT00769587CI-TRIAL-00095596completedClinicalTrials.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)
RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease. PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Neoplastic Condition | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thalidomide
- description
- Use of thalidomide
- interventionNames
- Drug: thalidomide
Primary outcomes (1)
- measure
- Objective reduction of the infiltration rate at 6 months
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of systemic mastocytosis * Aggressive or borderline (smoldering) disease (in first line or more) * Relapsed or progressive disease * Measurable or evaluable disease * Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs * No nonsymptomatic mastocytosis PATIENT CHARACTERISTICS: * Life expectancy \> 3 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment * Bilirubin \< 2 times normal (unrelated to disease) * Liver enzymes \< 2 times normal (unrelated to disease) * Creatinine ≤ 300 mmol/L * No central or peripheral neuropathy leading to psychiatric concerns * No HIV positivity * No active infection or other serious underlying illness that would preclude treatment * No history of thromboembolism or deep vein thrombosis * No geographical, social, or psychological reasons preventing medical monitoring PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy) * No other concurrent treatment specific for this disease * No concurrent participation in another experimental drug trial
References
Publications (1)
- RESULTGruson B, Lortholary O, Canioni D, Chandesris O, Lanternier F, Bruneau J, Grosbois B, Livideanu C, Larroche C, Durieu I, Barete S, Sevestre H, Diouf M, Chaby G, Marolleau JP, Dubreuil P, Hermine O, Damaj G. Thalidomide in systemic mastocytosis: results from an open-label, multicentre, phase II study. Br J Haematol. 2013 May;161(3):434-42. doi: 10.1111/bjh.12265. Epub 2013 Feb 22. PMID 23432617