Tansfusion of granulocytes for patients with febrile neutropenia

Phase 3

• Conditions: MedDRA - 10016288: febrile Neutropenie / Febrile neutropenia; C92.0; C91.0; C92.1; C91.1; D46.9; D47.1; C82; C83; C84.4

• Registration Number: DRKS00000218
• Lead Sponsor: niversität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

symptomatic coronary heart disease
cardial insuffiency NYHA III or IV
lungdisease with dyspnoea WHO III or IV
oxygensaturation < 80%
severe therapy-refractory arterial hypertension
non-therapy-induced neutropenia (e.g. aplastic anemia)
active psychiatric disease
severe kidney-dysfunction (creatinine-clearance < 60 ml/min)
severe hepatic-dysfunction with bilirubin > 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of temperature (auricularly or orally);<br>Interventiongroup: 1h before, at starting time and ending of the transfusion of granulocytes, 1h, 12h and 24h after the transfusion.<br>Controlgroup: 0h (equates to 1h before the transfusion in the interventiongroup), 12h and 24h<br>Endpoint: the normalisation of the temperature (measurement intraauricular or oral; <38°C) for 72h

Secondary Outcome Measures

Name	Time	Method
End of neutropenia (not as a consequence of transfusions);<br>Value of neutrophile granulocytes in a bloodsample > 500/µl on two following days in an upward trend