Description:
Assessment of efficacy of azacitidine to prevent a relapse
Title
- Brief Title: Treatment of Patients With Myelodysplastic Syndrome or Acute Myelocytic Leukemia With an Impending Hematological Relapse With Azacitidine (Vidaza)
- Official Title: Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)
Clinical Trial IDs
- ORG STUDY ID:
TUD-RELA02-048
- SECONDARY ID:
2010-022388-37
- SECONDARY ID:
VZ-MDS-PI-0245
- NCT ID:
NCT01462578
Conditions
- Acute Myelocytic Leukemia
- Myelodysplastic Syndrome
Interventions
Drug | Synonyms | Arms |
---|
Azacitidine | Vidaza® | Azacytidine |
Purpose
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 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
Trial Arms
Name | Type | Description | Interventions |
---|
Azacytidine | Experimental | Azacytidine injection: 75 mg/m²/d, subcutaneous | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of patients with hematological relapse 6 months after start of treatment with azacitidin |
Time Frame: | 6 months after end of treatment |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD |
Time Frame: | 2 years follow-up after treatment |
Safety Issue: | |
Description: | |
Measure: | Number of patients with infectious SAEs (rate of SAE) |
Time Frame: | 2 years follow-up after treatment |
Safety Issue: | |
Description: | |
Measure: | Rate of changes of methylation in CD34+ cells |
Time Frame: | 2 years follow-up after treatment |
Safety Issue: | |
Description: | |
Measure: | Relapse-free survival and overall survival |
Time Frame: | 12, 24 and 30 months after start of treatment |
Safety Issue: | |
Description: | Relapse-free survival and overall survival 12, 24 and 30 months after start of treatment |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Technische Universität Dresden |
Trial Keywords
- Neoplasms benign, malignant and unspecified
- Acute myeloid leukemia
- AML
- Myelodysplastic syndrome
- MDS
Last Updated
December 10, 2018