Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis (NCT00769587) | Clinical Trial Compass
CompletedNot Applicable
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
FranceStarted 2007-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective reduction of the infiltration rate at 6 months