Tissue Collection for Biomarkers Determining Resistance to Ibrutinib

NCT02267590 | Unknown

• 1 other identifier: CCR4187
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical validation of biomarkers determining resistance to BTK inhibition with Ibrutinib in Mantle Cell Lymphoma and Chronic Lymphocytic Leukaemia Stage 1.

Conditions

Mantle Cell Lymphoma; Chronic Lymphocytic Leukaemia

Outcome Measures

Primary Outcomes (1)

• Total number of MCL and CLL patient samples collected, both pre-treatment and at progression.

  24 months

Study Arms (2)

MCL: 80-100 samples from 60- 70 patients

Mantle Cell lymphoma patients

CLL: 15-20 samples from 10-15 patients

Chronic lymphocytic leukaemia patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Ibrutinib named patient supply (NPS) was introduced across the NHS for relapsed/ refractory CLL in April this year. Patients with relapsed/ refractory MCL were allowed to enter this programme in September. The NPS for CLL is likely to be open until the 30th of September this year while MCL patients can access Ibrutinib until the end of November. Strict inclusion and exclusion criteria have been set out for the NPS and patients are required to be screened through an online portal prior to entry on to the programme. The NPS provides an excellent window of opportunity to collect patient samples for this study.

You may qualify if:

• All patients entered into the Ibrutinib NPS for relapsed refractory MCL and CLL in the UK and who consent to have biological material stored for this research will be included in the study. Patients who have already commenced treatment with Ibrutinib will also be eligible whether or not they are responding.

You may not qualify if:

• All samples received will undergo histological (or morphological) review and immunophenotyping. The following samples will be excluded-
• Samples not satisfying the criteria for diagnosis of CLL or MCL.
• Samples with evidence of high grade transformation (e.g. Richter's transformation of CLL).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• University Hospital Plymouth NHS Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

20mls of PB in EDTA; 5ml of BM in EDTA and/or tissue biopsy (fresh/frozen/FFPE) and/or pleural/ascitic fluid containing tumour cells.

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Leukemia, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Central Study Contacts

Sunil Iyengar

CONTACT

020 8661 3202; sunil.iyengar@rmh.nhs.uk

Lorna Smith

CONTACT

020 8661 3018; lorna.smith2@rmh.nhs.uk

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 17, 2014

Record last verified: 2014-10

Locations

GB (1)