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 range18 Years
SexALL
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…
What they're measuring
1
Number of patients with hematological relapse 6 months after start of treatment with azacitidin