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Clinical Trials/EUCTR2017-000498-35-PT
EUCTR2017-000498-35-PT
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 enrollmentSeptember 3, 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
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 3, 2019
End Date
TBD
Last Updated
4 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 (i.v. contrast).
  • •\- 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.
  • •Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment.
  • •Patients of childbearing / reproductive potential should use two birth control methods, as defined by the investigator, from the time of signing the informed consent form , and throughout the entire study and for 6 months after the last dose of treatment.

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 (see Appendix D).
  • •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-SKEuropean Organisation for Research and Treatment of Cancer (EORTC)150
Recruiting
Phase 2
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