Verification of the effectiveness of adding granulocyte stimulating factor (G-CSF) to therapy patients with myelodysplastic syndrome (MDS) in high-risk disease.

Contribution to verify the effectiveness of adding granulocyte stimulating factor (G-CSF) to therapy 5 - Azacitidine patients with the high risk Myelodysplastic syndrome. - GA-MDS/ 2013

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001639-38-CZ

Enrollment

135

Registered

2016-07-26

Start date

2016-12-06

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with the diagnosis:HR-MDS, AML less than 30% myeloblasts and CMML II, who will be treated with AZA or AZA + G-CSF.

Interventions

Trade Name: AZACITIDINE 25 mg/ml (Vidaza) Product Name: AZACITIDINE 25 mg/ml Pharmaceutical Form: Powder for suspension for injection Trade Name: FILGRASTIM 30 MU (60 MU/ml) FILGRASTIM 48 MU (96 M

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients indicated for the treatment with Vidaza who are not eligible for haematopoietic stem cell transplantation with: - Myelodysplastic syndrome (MDS) second intermediate risk and high-risk (International Prognostic Scoring System, IPSS) - Chronic myelomonocytic leukemia without myeloproliferative features (CMML II according to WHO) - Acute myeloid leukemia (AML) with 20-30% blasts and dysplasia in several cell lines, according to the classification of WHO, 2. Patients who signed informed consent; 3. Patients = 18 years; 4. Patients without significant comorbidities (eg, comorbidities heart, liver, blood vessels, brain), reducing the chance of survival of less than six months; Patients unable to undergo therapy and plan visits, including necessary tests. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. The presence of other hematological, internal disease that limits survival for less than six months. 2. Pregnant women or women in lactation period 3. Man or woman of childbearing age without the willingness to use safe contraception. Details of the method of contraception, see the document "Information for the Patient / Informed Consent Form".

Design outcomes

Primary

Measure	Time frame
Main Objective: Prolongation of survival, prolong transformation to acute leukemia, reduce the incidence of infection and hospitalization, achieving transfusion independence and improving the quality of of life of patients with HR-MDS, AML and 30% myeloblasts and CMML II.;Secondary Objective: Determine the correlation of genetic changes and clinical response to a given therapy. To study the effectiveness of the selected treatment at the molecular level at the epigenetic parameters;Primary end point(s): Prolongation of survival, prolong transformation to acute leukemia, reduce the incidence of infection and hospitalization, achieving transfusion independence and improving the quality of of life of patients with HR-MDS, AML and 30% myeloblasts and CMML II.;Timepoint(s) of evaluation of this end point: Extension of survival and time transform by 50%	—

Measure

Time frame

Main Objective: Prolongation of survival, prolong transformation to acute leukemia, reduce the incidence of infection and hospitalization, achieving transfusion independence and improving the quality of of life of patients with HR-MDS, AML and 30% myeloblasts and CMML II.;Secondary Objective: Determine the correlation of genetic changes and clinical response to a given therapy. To study the effectiveness of the selected treatment at the molecular level at the epigenetic parameters;Primary end point(s): Prolongation of survival, prolong transformation to acute leukemia, reduce the incidence of infection and hospitalization, achieving transfusion independence and improving the quality of of life of patients with HR-MDS, AML and 30% myeloblasts and CMML II.;Timepoint(s) of evaluation of this end point: Extension of survival and time transform by 50%

—

Secondary

Measure	Time frame
Secondary end point(s): Determine the correlation of genetic changes and clinical response to a given therapy. To study the effectiveness of the selected treatment at the molecular level at the epigenetic parameters;Timepoint(s) of evaluation of this end point: Achieving the anticipated goals for the duration of the study	—

Countries

Czech Republic

Contacts

Public Contactprof. Tomas Stopka, MD

1st Dep. of Medicine, General University Hospital in Prague (VFN

Tomas.Stopka@lf1.cuni.cz420732561944

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026