Non Neoplastic ConditionNCT00769587
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
A study testing thalidomide in people with Non Neoplastic Condition and Precancerous Condition, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Neoplastic Condition, Precancerous Condition
- What is being tested?
- thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Thalidomide in Mastocytosis
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.
- Conditions
- Non Neoplastic Condition, Precancerous Condition
- Being tested
- thalidomide
- Keywords
- aggressive systemic mastocytosis, smoldering systemic mastocytosis
- Medical subject headings
- Precancerous Conditions, Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Experimental | Use of thalidomide Receives: Drug: thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective reduction of the infiltration rate at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Neoplastic ConditionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gandhi Damaj, Study chair, Centre Hospitalier Universitaire, Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769587
- Sponsor's protocol ID
- PI06-DR-DAMAJ
- Other IDs
- CHU-AMIENS-PI06, EUDRACT-2006-005087-10, INCA-RECF0510
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2008
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Thalidomide in Mastocytosis
- ClinicalTrials.gov ID
- NCT00769587
- Acronym / sponsor ID
- PI06-DR-DAMAJ
- Conditions
- Non Neoplastic Condition, Precancerous Condition
- Keywords
- aggressive systemic mastocytosis, smoldering systemic mastocytosis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Experimental | Drug: thalidomideUse of thalidomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thalidomide | Drug | Thalidomide |
Primary outcome
Objective reduction of the infiltration rate at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Results publication: PubMed 23432617Gruson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gandhi Damaj study chair
Centre Hospitalier Universitaire, Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thalidomide in people with Non Neoplastic Condition and Precancerous Condition, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective reduction of the infiltration rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.