Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia

B-cell Chronic Lymphocytic Leukemia Clinical Trial

— CLL004  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01982175
• Other study ID #: CMAB004
• Status: Suspended
• Phase: Phase 2
• Start date: July 2011
• Est. completion date: June 2022

Study information

• Verified date: June 2022
• Source: Shanghai Zhangjiang Biotechnology Limited Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: June 2022
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

• Pregnant or nursing women.

• Known central nervous system(CNS) metastases with B-CLL.

• Active secondary malignancy.

• cytomegalovirus(CMV) positive or immunodeficiency disease or after stem cell transplantation.

Related Conditions & MeSH terms

• B-cell Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Biological:
• Alemtuzumab
Escalation Phase: Initial Doses of Alemtuzumab 3mg/day by intravenous(IV) infusion until tolerated, then Alemtuzumab 10mg/day IV infusion until tolerated, then Alemtuzumab 30mg IV infusion until tolerated. Escalation to 30mg/day should be accomplished in 3~7 days. Stable dose Phase: Once 30mg/day infusion of Alemtuzumab was tolerated, then continue 3 times per week. The total duration of Alemtuzumab therapy including escalation and stable dose phase is 12 weeks. More than 30mg daily or 90mg weekly dose is prohibited --------------------------------------------------------------------------------

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhangjiang Biotechnology Limited Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate(ORR)	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	up to 1 year
Secondary	Progression-Free Survival	Progression-Free Survival was defined as the time from randomization to disease progression (PD) or death due to any cause, whichever comes first.	up to 1 year
Secondary	Disease Control Rate(DCR)	Patients were evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. The best response observed during the study is summarized. Response categories include Complete Response(CR), Partial Response(PR) and Stable Disease(SD).; DCR=CR+PR+SD	up to 1 year
Secondary	Duration of Response(DOR)	Duration of response was analyzed for patients who achieved a complete release(CR) or partial release(PR) and was defined as the time from the first date of documented response to the date of disease progression or death due to any cause.	up to 1 year
Secondary	Overall Survival	Overall Survival was defined as the duration from randomization to death due to any cause.	up to 1 year
Secondary	Summary of patients with Adverse Events(AEs)	Analysis of patients with adverse experiences according to CTCAE Version 4.	up to 1 year