Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impendin… (NCT01462578) | Clinical Trial Compass
CompletedPhase 2
Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
Germany93 participantsStarted 2011-09
Plain-language summary
Assessment of efficacy of azacitidine to prevent a relapse
Who can participate
Age range
18 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.
Inclusion Criteria:
Screening:
* signed informed consent
* Age ≥18 years
* patients with MDS or AML after conventional chemotherapy or allogeneic HSCT and positive molecular marker such as t(6,9), NPM1 pos. or CD34+ or CD117+ in the case of an allogeneic HSCT
Treatment:
* MDS or AML without haematological relapse (blasts \<5% in the bone marrow), and
* decrease of CD34 donor chimerism (\<80%) after allogeneic related or unrelated HSCT in CD34+ or CD117+ MDS or AML or
* increase in the AML-specific molecular marker in the quantitative PCR for t(6,9), NPM1+ AML \>1% after conventional chemotherapy or allogeneic HSCT or
* persistence of the (above) MRD levels \>1% (relative to the reference gene) after conventional chemotherapy or allogeneic HSCT
* leukocytes \> 3 Gpt/l and platelets \>75 Gpt/l (transfusion independent)
Exclusion Criteria:
* Known history of hypersensitivity to any of the drugs used or their constituents or to drugs with similar chemical structure,
* Participation of the patient in another clinical trial within the last 4 weeks before the inclusion
* addiction or other disorders that do not allow the concerned person, to assess the nature and scope and possible consequences in the clinical investigation
* pregnant or breast feeding women
* women of childbearing potential, except women who meet the following criteria:
* post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH \>40 U/ml)
* postoperative (6 weeks after hysterec…
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
Number of patients with hematological relapse 6 months after start of treatment with azacitidin