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

NCT ID: NCT01982175

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2022-06-30

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.

Conditions

B-cell Chronic Lymphocytic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alemtuzumab

Patients receive Alemtuzumab escalated from initial dose of 3mg/day then 10mg/day and up to 30mg/day by intravenous infusion(if tolerated). when stable dose of 30mg/day is tolerated, Alemtuzumab is administrated at 30mg by IV infusion 3 times per week for up to 12 weeks (including escalation and stable dose period). After completion of 12 weeks treatment, or discontinuation of treatment within 12 weeks due to disease progression, patients will be visited every 3 months up to 1 year from enrollment or to death, whichever occurs first.

Group Type: EXPERIMENTAL

Alemtuzumab

Intervention Type: BIOLOGICAL

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

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Interventions

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

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Intervention Type: BIOLOGICAL

Other Intervention Names

Recombinant Humanized Anti-CD52 Mab

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhangjiang Biotechnology Limited Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Zhu, M.D.

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CMAB004

Identifier Type: -

Identifier Source: org_study_id