Study to learn if 200mg test drug (Fostamatinib) helps people with Large B-Cell Lymphoma, a type of blood cancer
- Conditions
- Diffuse Large B-cell LymphomaMedDRA version: 16.1Level: LLTClassification code 10012820Term: Diffuse large B-cell lymphoma NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-005371-16-GB
- Lead Sponsor
- Rigel Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
* Aged at least 18 years of age
* Patients with relapsed or refractory diffuse large B-cell lymphoma who have previously received R-CHOP (or equivalent) chemo-immunotherapy and high dose chemotherapy with stem cell rescue, or who are ineligible for high dose therapy with stem cell rescue
* Measurable disease as defined by Cheson et al 2007 criteria
* One fresh pre-treatment excisional or core needle biopsy from suitable and accessible site
* World Health Organization (WHO) performance status 0 to 1
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
* Treatment with nitrosurea, mitomycin C, investigational agents or study drugs w/in28 days of first dose of study treatment, any other chemotherapy, immunotherapy or anticancer agents w/in 3 weeks of first dose of study treament, previous fostamatinib
* With the exception of alopecia, any unresolved toxicities from prior therapy or surgery greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1
* Uncontrolled hypertension (defined as >140mmHg systolic and/or > 90 mmHG diastolic at baseline with or without antihypertensive therapy)
* Evidence of tuberculosis (TB)
* Inadequate bone marrow reserve
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method