Non Hodgkin Lymphoma Clinical Trial

Study to Evaluate CCS1477 in Haematological Malignancies

Summary

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

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Full Description

This includes patients with Peripheral T-cell lymphoma.

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Eligibility Criteria

Inclusion Criteria:

Provision of consent
ECOG performance status 0-2
Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
Must have previously received standard therapy
Adequate organ function

Exclusion Criteria:

Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
Patients should discontinue statins prior to starting study treatment
CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
Any unresolved reversible toxicities from prior therapy >CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
Any evidence of severe or uncontrolled systemic diseases
Any known uncontrolled inter-current illness
QTcF prolongation (> 480 msec)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

250

Study ID:

NCT04068597

Recruitment Status:

Recruiting

Sponsor:

CellCentric Ltd.

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There are 11 Locations for this study

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Mayo Clinic
Phoenix Arizona, 85054, United States
Institute Bergonie
Bordeaux , 33000, France
Institute Gustave Roussy
Villejuif , 94805, France
University Hospital Vall D'Hebron
Barcelona , 08035, Spain
CIOCC Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Karolinska Institute
Stockholm , 171 7, Sweden
The Royal Marsden
Sutton Surrey, SM2 5, United Kingdom More Info
Dima El-Sharkawi
Contact
University Hospital of Wales
Cardiff , , United Kingdom More Info
Steven Knapper
Contact
Western General Hospital
Edinburgh , EH4 2, United Kingdom More Info
Victoria Campbell
Contact
Gartnavel General Hospital
Glasgow , G12 0, United Kingdom More Info
Mhairi Copland
Contact
Leicester Royal Infirmary
Leicester , , United Kingdom More Info
Harriet Walter
Contact
NIHR University College London Clinical Research Facility
London , W1T 7, United Kingdom More Info
Jenny O'Nions
Contact
The Christie Hospital
Manchester , , United Kingdom More Info
Tim Somervaille
Contact
Cancer and Haematology Centre
Oxford , , United Kingdom More Info
Paresh Vyas
Contact
University Hospital of Southampton
Southampton , SO16 , United Kingdom More Info
Andy Davies
Contact

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

250

Study ID:

NCT04068597

Recruitment Status:

Recruiting

Sponsor:


CellCentric Ltd.

How clear is this clinincal trial information?

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