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

Primary Purpose

B-cell Chronic Lymphocytic Leukemia

Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Alemtuzumab
Sponsored by
Shanghai Zhangjiang Biotechnology Limited Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia focused on measuring Alemtuzumab, B-cell chronic lymphocytic leukemia, CD52

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking University Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alemtuzumab

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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.
Overall Survival
Overall Survival was defined as the duration from randomization to death due to any cause.
Summary of patients with Adverse Events(AEs)
Analysis of patients with adverse experiences according to CTCAE Version 4.

Full Information

First Posted
November 5, 2013
Last Updated
June 15, 2022
Sponsor
Shanghai Zhangjiang Biotechnology Limited Company
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1. Study Identification

Unique Protocol Identification Number
NCT01982175
Brief Title
Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Suspended
Why Stopped
recruiting difficulties
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2021 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhangjiang Biotechnology Limited Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Chronic Lymphocytic Leukemia
Keywords
Alemtuzumab, B-cell chronic lymphocytic leukemia, CD52

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alemtuzumab
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Alemtuzumab
Other Intervention Name(s)
Recombinant Humanized Anti-CD52 Mab
Intervention Description
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 --------------------------------------------------------------------------------
Primary Outcome Measure Information:
Title
Objective Response Rate(ORR)
Description
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
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Description
Progression-Free Survival was defined as the time from randomization to disease progression (PD) or death due to any cause, whichever comes first.
Time Frame
up to 1 year
Title
Disease Control Rate(DCR)
Description
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
Time Frame
up to 1 year
Title
Duration of Response(DOR)
Description
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.
Time Frame
up to 1 year
Title
Overall Survival
Description
Overall Survival was defined as the duration from randomization to death due to any cause.
Time Frame
up to 1 year
Title
Summary of patients with Adverse Events(AEs)
Description
Analysis of patients with adverse experiences according to CTCAE Version 4.
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Peking
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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