Back to results

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

Primary Purpose

Myeloid Leukemia, Myelodysplastic Syndrome

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

5-Azacytidin

About this trial

This is an interventional treatment trial for Myeloid Leukemia focused on measuring Acute myeloid leukaemia or Myelodysplastic syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University hospital Dresden, department of medicine

Outcomes

Primary Outcome Measures

Efficacy 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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00422890

First Posted

January 15, 2007

Last Updated

July 8, 2011

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT00422890

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Technische Universität Dresden

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myeloid Leukemia, Myelodysplastic Syndrome

Keywords

Acute myeloid leukaemia or Myelodysplastic syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

5-Azacytidin

Intervention Description

in case of decreasing CD34 chimerism

Primary Outcome Measure Information:

Title

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uwe Platzbecker, MD

Organizational Affiliation

Univesity Hospital Dresden, department of medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

University hospital Dresden, department of medicine

City

Dresden

State/Province

Saxony

ZIP/Postal Code

01307

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26202768

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs