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Clinical Trials/EUCTR2017-000498-35-SK
EUCTR2017-000498-35-SK
Active, not recruiting
Phase 1

Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study - COBRA

European Organisation for Research and Treatment of Cancer (EORTC)0 sites150 target enrollmentJune 20, 2019
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ConditionsAdvanced stage Hodgkin LymphomaMedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10020206Term: Hodgkin's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10020243Term: Hodgkin's disease NECSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsAdcetris

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Advanced stage Hodgkin Lymphoma
Sponsor
European Organisation for Research and Treatment of Cancer (EORTC)
Enrollment
150
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 20, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
European Organisation for Research and Treatment of Cancer (EORTC)

Eligibility Criteria

Inclusion Criteria

  • •Previously untreated, histologically proven classical Hodgkin lymphoma;
  • •Staged by PET with diagnostic\-quality CT.
  • •\- Clinical stages according to Lugano 2014 and based on FDG/PET CT:Stage IIB with large mediastinal mass \> 1/3 max transverse diameter thorax and/or extranodal lesion(s) (GHSG)
  • •\- Stage III \- IV
  • •Participation in translational research is mandatory and therefore patient must consent to additional blood samples at multiple time points
  • •in the study. In addition, sufficient tissue must be available (15 blank
  • •formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block).
  • •Age \=18 and \=60
  • •WHO performance status 0\-2
  • •Patient demonstrates adequate organ function as defined in the protocol.

Exclusion Criteria

  • •Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy
  • •Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
  • •Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 5\.0
  • •Any of the following cardiovascular conditions or values:
  • •\- within 6 months before registration:
  • •A left\-ventricular ejection fraction \<50%
  • •New York Heart Association (NYHA) Class III or IV heart failure.
  • •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • •symptomatic coronary heart disease (stable angina pectoris is allowed)
  • •severe uncontrolled hypertension defined as blood pressure (BP) \>150/100 mmHg despite optimal antihypertensive treatment

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II studyAdvanced stage Hodgkin LymphomaMedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10020206Term: Hodgkin's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10020243Term: Hodgkin's disease NECSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-000498-35-PLEuropean Organisation for Research and Treatment of Cancer (EORTC)150
Active, not recruiting
Phase 1
Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II studyAdvanced stage Hodgkin LymphomaMedDRA version: 20.1 Level: LLT Classification code 10080208 Term: Classical Hodgkin lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10020206 Term: Hodgkin's disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10020243 Term: Hodgkin's disease NEC System Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-000498-35-BEEuropean Organisation for Research and Treatment of Cancer (EORTC)150
Active, not recruiting
Phase 1
Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II study
EUCTR2017-000498-35-DKEuropean Organisation for Research and Treatment of Cancer (EORTC)150
Active, not recruiting
Phase 1
Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II studyAdvanced stage Hodgkin LymphomaMedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10020206Term: Hodgkin's diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10020243Term: Hodgkin's disease NECSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2017-000498-35-PTEuropean Organisation for Research and Treatment of Cancer (EORTC)150
Recruiting
Phase 2
Very early FDG-PET-response adapted targeted therapy for advanced Hodgkin lymphoma: a single-arm phase II studyHodgkin's diseasemalignant lymphoma10025319
NL-OMON50149European Organisation for Research in Treatment of Cancer (EORTC)38