GRANITE-1 - Transmission of specific immune cells from healthy donors for cancer patients with fever, who lack these cells

Phase 1

• Conditions: Febrile neutropenia due to chemotherapy for the following diseases:C92.0- - Acute myeloid leukemiaC91.0- - Acute lymphoblastic leukemiaC92.1- - Chronic myeloid leukemiaC91.1- - Chronic lymphoblastical leukemiaD46.9 - Myelodysplastic syndromeD47.1 - Chronic myeloproliferative diseaseC82.- - Follicular/nodular NHLD83.- - Diffuse Non-Hodgkin's Lymphoma (NHL)C84.4 - Peripheral T-Cell NHLC90.0- - Multiple myelomaC81.9 - Hodgkin's lymphoma (HL); MedDRA version: 14.0Level: PTClassification code 10016288Term: Febrile neutropeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-010700-28-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-22
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Mesurement of bodytemperature; <br>>> in interventional group: 1h before, on start and end of the granulocyte-transfusion (Gtx), 1h, 12h and 24h after granulocyte-transfusion; <br>>> in control-group: 0h (same as 1h before Gtx in interventional-group), 1h, 12h and 24h; Endpoint defined as afebrile patient (body temperature intraauricular < 38°C) for 72h;Secondary Objective: End of neutropenia (not as a consequence of transfusions); Value of neutrophile granulocytes in a bloodsample > 500/µl on two following days in an upward trend;Primary end point(s): Measurement of temperature (auricularly or orally)<br>;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. <br>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 Outcome Measures

Name	Time	Method
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