Status:
COMPLETED
Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
Lead Sponsor:
Technische Universität Dresden
Conditions:
Acute Myelocytic Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Assessment of efficacy of azacitidine to prevent a relapse
Detailed Description
Analysis of the effectiveness of azacitidine 6 months after start of therapy to prevent a hematological relapse in MDS or AML patients with significant residuals or an increase of minimal residual dis...
Eligibility Criteria
Inclusion
- 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
- 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 hysterectomy with or without bilateral ovariectomy )
- regular and proper use of a contraceptive method with error rate \<1% per year (e.g., implants, depot injections, oral contraceptives, intrauterine device, IUD) during study treatment and up to 1 year after completion of therapy
- sexual abstinence during study treatment and up to 1 year after completion of therapy
- Vasectomy of the partner
- Men who do not use one of the following types of effective contraception during study treatment and up to 1 year after completion of therapy:
- sexual abstinence
- State post-vasectomy
- Condom
- Evidence that the participating person is not expected to comply with the protocol (such as lack of cooperation)
- Uncontrolled active infection
- Severe hepatic impairment (AST and ALT may not exceed three times the normal) or liver cirrhosis or malignant liver tumor
- Dialysis dependent renal dysfunction
- Known severe congestive heart failure, incidence of clinically unstable cardiac or pulmonary disease These criteria are not for the screening phase up to a known allergic reaction to azacitidine or intolerance to apply.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT01462578
Start Date
September 1 2011
End Date
February 1 2021
Last Update
November 15 2021
Active Locations (11)
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1
Charité Campus Benjamin Franklin
Berlin, Germany
2
Universitätsklinikum Bonn
Bonn, Germany
3
Klinikum Chemnitz (Küchwald)
Chemnitz, Germany
4
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I
Dresden, Germany