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

NCT01982175 | Suspended Phase 2

• 1 other identifier: CMAB004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Alemtuzumab; B-cell chronic lymphocytic leukemia; CD52

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-Free Survival

  up to 1 year

• Disease Control Rate(DCR)

  up to 1 year

• Duration of Response(DOR)

  up to 1 year

• Overall Survival

  up to 1 year

• Summary of patients with Adverse Events(AEs)

  up to 1 year

Study Arms (1)

Alemtuzumab

EXPERIMENTAL

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.

Biological: Alemtuzumab

Interventions

Alemtuzumab 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 \--------------------------------------------------------------------------------

Also known as: Recombinant Humanized Anti-CD52 Mab

Alemtuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhangjiang Biotechnology Limited Company: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jun Zhu, M.D.

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 13, 2013
• Study Start: July 1, 2011
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

CN (1)