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Clinical Trials/NL-OMON50149
NL-OMON50149
Recruiting
Phase 2

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

European Organisation for Research in Treatment of Cancer (EORTC)0 sites38 target enrollmentTBD
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ConditionsHodgkin's diseasemalignant lymphoma10025319

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hodgkin's disease
Sponsor
European Organisation for Research in Treatment of Cancer (EORTC)
Enrollment
38
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •\- Classical Hodgkin lymphoma, histologically proven, previously untreated
  • •\- Staged by FDG\-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)
  • •\> Stage III \- IV
  • •\- Age \>\=18 and \<\=60
  • •\- WHO performance status 0\-2 (Appendix C)
  • •\- Adequate organ function (for specification see 3\.1\.1 protocol page 24\)
  • •\- Absence of any medical, psychological, familial, sociological or geographical

Exclusion Criteria

  • •\- Cerebral or meningeal disease (HL or any other etiology), including signs or
  • •symptoms of Progressive Multifocal Leukoencephalopathy
  • •\- Symptomatic neurologic disease compromising normal activities of daily living
  • •or requiring medications
  • •\- Sensory or motor peripheral neuropathy \>\= grade 2 according to CTCAE version
  • •\- Cardiovascular conditions (specifications see protocol 3\.1\.2 p 25\)
  • •\- Poorly controlled diabetes mellitus (HbA1c \> 7\.5 % or a fasting blood sugar \>
  • •200 mg/dL).
  • •\- Any active systemic viral, bacterial, or fungal infection requiring systemic
  • •antibiotics within 2 weeks prior to registration.

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
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