EUCTR2017-000498-35-BE
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 enrollmentNovember 21, 2018
ConditionsAdvanced 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]
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
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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 for it. The following material must be available:
- •\- Archival tumor tissue available (15 blank formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block);
- •\- To allow sequential sampling of blood during the course of the trial.
- •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 (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
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