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Clinical Trials/DRKS00000218
DRKS00000218
Recruiting
Phase 3

Tansfusion of granulocytes for patients with febrile neutropenia - GRANITE

niversität zu Köln0 sites100 target enrollmentMay 4, 2011
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ConditionsMedDRA - 10016288: febrile Neutropenie / Febrile neutropeniaC92.0C91.0C92.1C91.1D46.9D47.1C82C83C84.4C90.0C81.9Acute myeloblastic leukaemia [AML]Acute lymphoblastic leukaemia [ALL]Chronic myeloid leukaemia [CML], BCR/ABL-positiveChronic lymphocytic leukaemia of B-cell typeMyelodysplastic syndrome, unspecifiedChronic myeloproliferative diseaseFollicular lymphomaNon-follicular lymphomaPeripheral T-cell lymphoma, not elsewhere classifiedMultiple myelomaHodgkin lymphoma, unspecified

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
MedDRA - 10016288: febrile Neutropenie / Febrile neutropenia
Sponsor
niversität zu Köln
Enrollment
100
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 4, 2011
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversität zu Köln

Eligibility 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

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)

Outcomes

Primary Outcomes

Not specified

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