PET in aggressive lymphoma

Phase 1

• Conditions: Aggressive non-Hodgkin's lymphomas (first line therapy); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-001641-33-DE
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-25
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 696

Inclusion Criteria

Diagnosis of aggressive non-Hodgkin's lymphoma
B cell type
diffuse large B cell lymphoma including variants and subtypes
follicular lymphoma grade 3
T cell type
anaplastic large T or 0 cell lymphoma
angioimmunoblastic T cell lymphoma
peripheral T cell lymphoma not otherwise specified
intestinal T/NK cell lymphoma
hepatosplenic gamma-delta T cell lymphoma
subcutaneous panniculitis-like T cell lymphoma
Pathological PET scan before treatment
Performance status ECOG 0 - 3
Age 18 - 80 years
Effective contraception
Availability of patient for treatment and follow-up
Ability to understand the purpose of the trial and act accordingly
Compliance of patient
Signed informed consent
Lack of exclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

Burkitt's lymphoma
Primary cerebral lymphoma
Start of therapy before attempted inclusion (except pre-phase therapy of the study protocol)
Prior chemo- and/or radiotherapy
Other neoplastic diseases within the preceding 5 years (except carcinoma in situ or basal cell carcinoma of the skin)
Active viral hepatitis, HIV infection or other uncontrolled infections
Severe organ dysfunction not explained by the lymphoma precluding administration of chemotherapy according to the study protocol
Pregnancy
Lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified