Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia (CLL004)

Shanghai Zhangjiang Biotechnology Limited Company

Status and phase: Suspended; Phase 2

Conditions: B-cell Chronic Lymphocytic Leukemia

Treatments: Biological: Alemtuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01982175

CMAB004

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Alemtuzumab

Experimental group

Description:

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.

Treatment:

Biological: Alemtuzumab