Study to learn if 200mg test drug (Fostamatinib) helps people with Large B-Cell Lymphoma, a type of blood cancer

Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) - Not Applicable

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005371-16-GB

Enrollment

Registered

2011-11-24

Start date

2012-07-30

Completion date

Unknown

Last updated

2015-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma MedDRA version: 16.1 Level: LLT Classification code 10012820 Term: Diffuse large B-cell lymphoma NOS System Organ Class: 100000004864

Interventions

Product Name: fostamatinib tablet Product Code: fostamatinib tablet / formerly known as R935788 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: fostamatinib disodium CAS Number: 914295-16

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * 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

Exclusion criteria

Exclusion criteria: * 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of fostamatinib (200 mg bid) in patients with relapsed or refractory DLBCL, by assessing overall response rate (ORR);Secondary Objective: * To evaluate ORR and durable response rate (DRR) of patients with two distinct molecular subtypes of relpased or refractory DLBCL; B-cell receptor activation positive (BCA+) and B-cell receptor activation negative (BCA-). Several BCA signatures may be considered and selected signature(s) will be evaluated in a further study * To further evaluate the efficacy of fostamatinib (200 mg bid) in patients with relapsed or refractory DLBCL, by assessing duration of response (DoR) & progression free survival * To further evaluate the safety and tolerability of fostamatinib (200 mg bid) in the treatment of patients with relapsed or refractory DLBCL * To characterise the pharmacokinetics (PK) of R940406 (R406), the active metabolite of fostamatinib ;Primary end point(s): Overall Response Rate;Timepoint(s) of evaluation of this end point: A response rate of CR, PR, SD or relapsed disease will be assigned at week 8, 20, and 44 and/or final study visit	—

Measure

Time frame

Main Objective: To evaluate the efficacy of fostamatinib (200 mg bid) in patients with relapsed or refractory DLBCL, by assessing overall response rate (ORR);Secondary Objective: * To evaluate ORR and durable response rate (DRR) of patients with two distinct molecular subtypes of relpased or refractory DLBCL; B-cell receptor activation positive (BCA+) and B-cell receptor activation negative (BCA-). Several BCA signatures may be considered and selected signature(s) will be evaluated in a further study * To further evaluate the efficacy of fostamatinib (200 mg bid) in patients with relapsed or refractory DLBCL, by assessing duration of response (DoR) & progression free survival * To further evaluate the safety and tolerability of fostamatinib (200 mg bid) in the treatment of patients with relapsed or refractory DLBCL * To characterise the pharmacokinetics (PK) of R940406 (R406), the active metabolite of fostamatinib ;Primary end point(s): Overall Response Rate;Timepoint(s) of evaluation of this end point: A response rate of CR, PR, SD or relapsed disease will be assigned at week 8, 20, and 44 and/or final study visit

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Secondary

Measure	Time frame
Secondary end point(s): 1) Durable Response Rate 2) Progression Free Survival 3) Duration of Response 4) Safety 5) PK - to characterize the pharmacokinetics of R940406 (R406), the active metabolite of fostamatini;Timepoint(s) of evaluation of this end point: 1) Week 8, 20, and 44 and/or final study visit 2) Week 8, 20, and 44 and/or final study visit 3) Week 8, 20, and 44 and/or final study visit 4) Safety will be assessed in terms of adverse events, other significant adverse events, laboratory data/vital signs collected at all visits (Week 0, 1,2,3,4,8,12,16,20,44) 5) Before dosing, and at 1, 2, 4 and 8 hours after dosing on days 1, 8, and 29 and at each clinic visit every 8 to 16 weeks. Pts who have dose reduced will have one post dose PK sample drawn 1 to 4 hours after receiving their first treatment at lower dose leve 6) Pretreatment Blood Samples	—

Measure

Time frame

Secondary end point(s): 1) Durable Response Rate 2) Progression Free Survival 3) Duration of Response 4) Safety 5) PK - to characterize the pharmacokinetics of R940406 (R406), the active metabolite of fostamatini;Timepoint(s) of evaluation of this end point: 1) Week 8, 20, and 44 and/or final study visit 2) Week 8, 20, and 44 and/or final study visit 3) Week 8, 20, and 44 and/or final study visit 4) Safety will be assessed in terms of adverse events, other significant adverse events, laboratory data/vital signs collected at all visits (Week 0, 1,2,3,4,8,12,16,20,44) 5) Before dosing, and at 1, 2, 4 and 8 hours after dosing on days 1, 8, and 29 and at each clinic visit every 8 to 16 weeks. Pts who have dose reduced will have one post dose PK sample drawn 1 to 4 hours after receiving their first treatment at lower dose leve 6) Pretreatment Blood Samples

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Countries

United Kingdom, United States

Contacts

Public ContactTheresa Musser

Rigel Pharmaceuticals, Inc

tmusser@rigel.com1-6506241171

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026