Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza) (RELAZA2)

Technische Universität Dresden

Status and phase

Completed

Phase 2

Conditions

Myelodysplastic Syndrome

Acute Myelocytic Leukemia

Treatments

Drug: Azacitidine

Study type

Interventional

Funder types

Other

Identifiers

NCT01462578

2010-022388-37 (EudraCT Number)

TUD-RELA02-048

VZ-MDS-PI-0245 (Other Identifier)

Details and patient eligibility

About

Assessment of efficacy of azacitidine to prevent a relapse

Full 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 disease (MRD) which is defined as:

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 markers in the quantitative PCR for t(6,9), NPM1+ AML >1% (ratio to reference gene) after conventional chemotherapy or allogeneic HSCT or
persistence of the (above) MRD level >1% after conventional chemotherapy or allogeneic HSCT
tolerance of azacitidine
quality of the response of the MRD (major vs. minor) and the relapse-free survival and overall survival 12, 24 and 30 months after starting treatment with azacitidine
modulation of CD34+, NK- and T-cells of MDS and AML patients by azacitidine

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.