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

Phase 1

• 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.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001639-38-CZ
• Lead Sponsor: 1st Dep. of Medicine, General University Hospital (VFN) in Prague

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-26
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 135

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Determine the correlation of genetic changes and clinical response to a given therapy.<br>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