Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)

NCT ID: NCT00422890

Last Updated: 2011-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

Brief Summary

Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation.

Conditions

Myeloid Leukemia; Myelodysplastic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

5-Azacytidin

in case of decreasing CD34 chimerism

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Screening phase:

• Age > 18 years
• Patients with CD34+ AML or MDS post-allogeneic HSCT
• Written patient consent after consultation

Treatment phase

• AML/MDS: donor chimerism < 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts < 5% in bone marrow)
• Leukocytes > 3 Gpt/l and platelets > 75 Gpt/l (transfusion-independent)

Exclusion Criteria

• Known intolerance to 5-azacitidine or mannitol
• Uncontrollable infectious disease
• Patients with active hepatitis B or C or HIV infection
• Severe hepatic function impairment (ASAT and ALAT may not be above three times the normal value) or hepatic cirrhosis, or malignant hepatic tumour
• Renal function impairment (creatinine > twice the normal value, creatinine clearance < 50 ml/min)
• Pregnancy or lactation
• Women of childbearing age, except for those who meet the following criteria:
• postmenopausal (12 months natural amenorrhoea)
• postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
• regular and correct use of a contraceptive method with an error rate < 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device - IUD, whereby hormonal coils with a Pearl Index of < 1% are safer than copper coils)
• sexual abstinence
• Partner vasectomy
• Men who do not use one of the following for contraception:
• sexual abstinence
• post vasectomy
• condoms
• Participation of the patient in a drug trial outside the indication of allogeneic transplantation up to four weeks before study initiation
• Addictive or other illnesses that prevent the person concerned from comprehending the nature and impact, as well as potentical consequences of the clinical trial
• Evidence that the patient may intentionally not comply with the protocol, e.g. lack of cooperation With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Dresden University of Technology

Principal Investigators

Uwe Platzbecker, MD

Role: PRINCIPAL_INVESTIGATOR

Univesity Hospital Dresden, department of medicine

Locations

University hospital Dresden, department of medicine

Dresden, Saxony, Germany

Countries

Germany

References

Colbers A, Best B, Schalkwijk S, Wang J, Stek A, Hidalgo Tenorio C, Hawkins D, Taylor G, Kreitchmann R, Burchett S, Haberl A, Kabeya K, van Kasteren M, Smith E, Capparelli E, Burger D, Mirochnick M; PANNA Network and the IMPAACT 1026 Study Team. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women. Clin Infect Dis. 2015 Nov 15;61(10):1582-9. doi: 10.1093/cid/civ587. Epub 2015 Jul 22.

Reference Type: DERIVED

PMID: 26202768 (View on PubMed)

Other Identifiers

2006-001040-31 (EudraCT Nr.)

Identifier Type: -

Identifier Source: secondary_id

TUD-RELAZA-008

Identifier Type: -

Identifier Source: org_study_id