A Phase 3 evaluation of how PET scans can help guide further therapy or no therapy for patients with previously untreated, high tumour burden follicular lymphoma

Phase 1

• Conditions: Previously untreated, high tumour burden follicular lymphoma; MedDRA version: 21.1Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004010-10-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-15
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

1. Must be =18 years of age at the time of signing the informed consent form.
2. Must be able to adhere to the study visit schedule and other protocol requirements.
3. Must have a documented diagnosis of follicular lymphoma (grade 1, 2 or 3a).
4. Must be at non-contiguous stage II, stage III or stage IV.
5. Must fulfil at least one of the Groupe d'Etude des Lymphomas Folliculaires (GELF) GELF criteria for high tumour burden:
a. Systemic symptoms (> 10% weight loss, temperature = 38°C for more than 5 days, abundant night sweats)
b. Performance status (PS) greater than 1 according to the Eastern Cooperative Oncology Group (ECOG) scale
c. Elevated lactate dehydrogenase (LDH) level
d. ß2-microglobulin level greater than 25.5 nM/L (3 µg/mL)
e. A single lymph node larger than 7 cm
f. Involvement of at least 3 nodal sites, each with diameter greater than 3 cm
g. Marked splenomegaly
h. Organ failure
i. Pleural effusion or ascites
j. Orbital or epidural involvement
k. Blood infiltration
l. Cytopenia
6. Must not have received prior systemic therapy (local radiotherapy is permitted).
7. Must have a WHO performance status score of less than or equal to 2.
8. Must agree to adhere to the Celgene guidance on pregnancy prevention.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340

Exclusion Criteria

1. Any serious medical condition that would prevent the subject from participating in the study.
2. Known active infection with HIV, HBV or HCV.
3. Pregnant or lactating females.
4. Central nervous system involvement as documented by spinal fluid cytology or imaging.
5. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer (TNM stage of T1a or T1b)
6. Any of the following laboratory abnormalities:
a. Absolute neutrophil count (ANC) <1,000/µL (1.0 X 109/L)
b. Platelet count <50,000/µL (50 X 109/L)
c. Serum alanine transaminase (ALT) > 3.0 x upper limit of normal (ULN)
d. Serum total bilirubin >1.5 x ULN unless due to Gilbert's Syndrome or biliary obstruction by lymphoma

Study & Design

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