Treatment of an imminent recurrence of the disease in patients with a Myelodysplastic syndrome or acute myeloid leukemia with azacitidine (Vidaza®)

Phase 1

• Conditions: Patients with AML or MDS >= 18 years of age after conventional chemotherapy or stem cell transplantation with significant residual disease or an increase of MRD (e.g. t(6,9), NPM1 or CD34+ or CD117+ in case of PBSC Tx); MedDRA version: 20.0Level: LLTClassification code 10060557Term: Acute myelocytic leukemiaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022388-37-DE
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-15
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 93

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 (CD34+/CD117+ positivity of blasts = 10% at any time prior to HSCT)
Treatment:
- MDS or AML without haematological relapse (blasts <5% in the bone marrow), and
- decrease of CD34+ or CD117+ donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 93
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93

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:
o post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH> 40 U/ml)
o postoperative (6 weeks after hysterectomy with or without bilateral ovariectomy)
o 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
o sexual abstinence during study treatment and up to 1 year after completion of therapy
o 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:
o sexual abstinence
o State post-vasectomy
o 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified