FLT-PET/CT compaired with FDG-PET/CT in determining the response to treatment of agressive Lymphoma

Phase 1

• Conditions: Patients with agressive lymphoma in first therapy; MedDRA version: 18.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003494-29-DE
• Lead Sponsor: Stanford University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-19
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

•All patients must have a histologic or cytological diagnosis DLBCL (including lymphomas/leukemias that newly transformed into DLBLC ) and be scheduled or currently be receiving the first cycle of first line chemotherapy with :
a)R-CHOP or R-EPOCH given every 21 days (R-CHOP-21 or R-EPOCH-21) which is taken for 4 weeks of their FDG-PET/CT and for 6 cycles or.
b)R-CHOP given every 21 days (R-CHOP-21) within 8 weeks of their enrollment and for 8 cycles or
c)R-CHOP-14 or R-EPOCH-14 (R-CHOP or R-EPOCH given every 14 days; between cycle 2 and 3 no CSF-administration for 21 days) within 6 weeks of their enrollment and for 6 cycles
• Patients undergoing consolidative external radiotherapy at the end of all 6 cycles of R-CHOP or R-EPOCH are eligible.
•Patients must be =18 years of age, but there will be no discrimination based on gender, race, creed, or ethnic background.
•Patients must sign an informed consent, and be mentally responsible.

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Subjects with significant concurrent medical complications that in the judgment of the Principal Investigator(s) could affect the patient's ability to complete the planned trial, including the multiple imaging studies.
•Expected non-compliance
•Patients unwilling or unable to give informed consent
•Participation on another clinical trial within the last 3 months

Study & Design

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