CClinicalTrials.gg
CompletedNCT00769587Updated Sep 22, 2025

Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

An interventional study of thalidomide in Non Neoplastic Condition and Precancerous Condition, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Centre Hospitalier Universitaire, Amiens · Interventional

Study type
Interventional
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.

Secondary

  • Determine the tolerability of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.

02

Conditions studied

  • Non Neoplastic Condition
  • Precancerous Condition

Keywords

  • aggressive systemic mastocytosis
  • smoldering systemic mastocytosis
03

In context

Precancerous Conditions

254 studies on the registry are indexed under Precancerous Conditions; 28 are open to participants now.

Browse Precancerous Conditions studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Study arms

  • Experimental
    Thalidomide

    Use of thalidomide

    Drug: thalidomide

Interventions

  • Drugthalidomide
06

What researchers measure

Primary outcomes

  1. Objective reduction of the infiltration rate at 6 months

    Time frame: 6 months

07

Study locations

1 site
  • Centre Hospitalier Universitaire d'Amiens
    Amiens, 80054, France
08

References and documents

Publications

  • Gruson 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. PubMed 23432617 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00769587
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Oct 9, 2008
Start date
Jun 2007
Primary completion
May 2011
Completion
Oct 2012
Last update
Sep 22, 2025

Study contacts

Gandhi Damaj
study chair · Centre Hospitalier Universitaire, Amiens

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion