A Multi-center, Open, Prospective, Phase II Study of Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in Patients With Relapse and Refractory B-cell Chronic Lymphocytic Leukemia

Shanghai Zhangjiang Biotechnology Limited Company1 site in 1 country120 target enrollmentJuly 2011

ConditionsB-cell Chronic Lymphocytic Leukemia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: B-cell Chronic Lymphocytic Leukemia
Sponsor: Shanghai Zhangjiang Biotechnology Limited Company
Enrollment: 120
Locations: 1
Primary Endpoint: Objective Response Rate(ORR)
Status: Suspended
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

June 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Zhangjiang Biotechnology Limited Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•An established diagnosis of B-cell chronic lymphocytic leukemia(B-CLL)
•Meet criteria of relapsed or refractory CLL
•Presence of one or more measurable lesions
•ECOG Score 0-1
•Life expectancy \> 3 months
•Female patients with childbearing potential must have a negative serum pregnancy test, male and female patients must agree to use an effective contraceptive method while on study treatment, and for a minimum 1 year following study therapy.

Exclusion Criteria

•Less than 2 weeks from prior anti-cancer therapy.
•Allergic to the antibody or any component of the investigational product.
•Other severe, concurrent diseases, including mental disorders, serious cardiac functional capacity (Class III or IV), uncontrolled diabetes.
•Use of investigational agents rather than Alemtuzumab.
•Active systematic infection or major organ malfunction requiring treatment.
•Serum total bilirubin greater than or equal to 1.5 times upper limits of normal; or Serum alanine aminotransferase (ALT) and/or serum aspartate aminotransferase (AST) greater than or equal to 2.5 times upper limits of normal ( no liver metastases); or ALT and/or AST greater than or equal to 5 times upper limits of normal (liver metastases).
•Blood urea nitrogen(BUN) greater than or equal to 1.5 times upper limits of normal or Serum creatinine greater than or equal to 1.5 times upper limits of normal.
•White blood cell(WBC) count\< 3.5×109/L or Absolute neutrophil count(ANC)\<1.5×109/L or platelet count\<75×109/L or Hemoglobin\<80g/L.
•Human immunodeficiency virus (HIV) positive.
•Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization.

Outcomes

Primary Outcomes

Objective Response Rate(ORR)

Time Frame: up to 1 year

Objective Response Rate was defined as the proportion of patients who have CR, PR during the study as evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. Response categories include Complete Response(CR) and Partial Response(PR). ORR=CR+PR