Febrile neutropenia due to chemotherapy for the following diseases: C92.0- - Acute myeloid leukemia C91.0- - Acute lymphoblastic leukemia C92.1- - Chronic myeloid leukemia C91.1- - Chronic lymphoblastical leukemia D46.9 - Myelodysplastic syndrome D47.1 - Chronic myeloproliferative disease C82.- - Follicular/nodular NHL D83.- - Diffuse Non-Hodgkin's Lymphoma (NHL) C84.4 - Peripheral T-Cell NHL C90.0- - Multiple myeloma C81.9 - Hodgkin's lymphoma (HL) MedDRA version: 14.0 Level: PT Classification
Conditions
Interventions
Product Name: Granulocyte-Transfusion
Product Code: no product code available
Pharmaceutical Form: Infusion
INN or Proposed INN: granulocyte apheresate
Current Sponsor code: granulocyte apheresate
Oth
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: valid informed consent, subscribed by patient or his/her attorney; One of the following diseases: - C92.0- acute myeloid leukaemia, - C91.0- acute lymphoblastic leukaemia, - C92.1- chronic myeloid leukaemia, - C91.1- chronic lymphatic leukaemia, - D46.9 myelodysplastic syndrome, unspecified, - D47.1 chronic myeloproliferative disease, - C82.- follicular (nodular) non-Hodgkin's lymphoma - C83.- diffuse non-Hodgkin's lymphoma - C84.4 peripheral T-cell lymphoma - C90.0- Multiple myeloma - C81.9 Hodgkin's lymphoma; Karnofsky Performance Status > 20% echocardiography: ejection-fraction > 40% creatinine clearance > 60ml/min Pulmonary function: oxygensaturation at least 80% therapy-refractory fever above 38°C without response to standard-therapy for 96 hours Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: symptomatic coronary heart disease cardial insuffiency NYHA III or IV lungdisease with dyspnoea WHO III or IV oxygensaturation 2 mg/dl insufficient therapy of a thyroid-dysfunction (T3/T4 out of the reference range) Pregnancy or lactation Noncontrollable life-threatening bleeding Intracerebrally process leading to an increase of intracranial pressure (bleeding, infectious disease, tumour) cerebral convulsions Karnofsky Performance Status < 20% participation in the clinical trial in the last 30 days medical or psychic condition, which does nor allow the patient to participate in the clinical trial, neither subscribe an informed consent, according to a doctor's opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mesurement of bodytemperature; >> in interventional group: 1h before, on start and end of the granulocyte-transfusion (Gtx), 1h, 12h and 24h after granulocyte-transfusion; >> in control-group: 0h (same as 1h before Gtx in interventional-group), 1h, 12h and 24h; Endpoint defined as afebrile patient (body temperature intraauricular 500/µl on two following days in an upward trend;Primary end point(s): Measurement of temperature (auricularly or orally) ;Timepoint(s) of evaluation of this end point: Interventiongroup: 1h before, at starting time and ending of the transfusion of granulocytes, 1h, 12h and 24h after the transfusion. Controlgroup: 0h (equates to 1h before the transfusion in the interventiongroup), 12h and 24h Endpoint: the normalisation of the temperature (measurement intraauricular or oral; <38°C) for 72h | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): End of neutropenia (not as a consequence of transfusions); ;Timepoint(s) of evaluation of this end point: Value of neutrophile granulocytes in a bloodsample > 500/µl on two following days in an upward trend | — |
Countries
Germany
Contacts
Public ContactPrincipal investigator
Priv.-Doz. Dr. Kai Hübel
Outcome results
None listed