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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma  with a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (abbreviated as DLBCL)

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)

Phase II Trial to evaluate the efficacy of 200mg fostamatinib

Research Site

Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma(DLBCL)

Age Continuous

Gender, Male/Female

Most patients were male (69.1%). The mean age (± standard deviation) was 63.6 ± 12.6 years. 

Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis.

Full analysis set - all randomised patients

Objective response rate

Overall Study

Bernadette Weidman 

By any cause in the absence of relapse or progression regardless of whether the patient withdraws from randomized.

Study to learn if 200mg test drug (Fostamatinib) helps people with Large B-Cell Lymphoma,a type of blood cancer - Not applicable

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

D4302C00001_CSR_Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator