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

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ClinicalTrials.gov Identifier: NCT01982175
Recruitment Status : Unknown
Verified November 2016 by Shanghai Zhangjiang Biotechnology Limited Company.
Recruitment status was:  Recruiting
First Posted : November 13, 2013
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhangjiang Biotechnology Limited Company

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.

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Biological: Alemtuzumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: 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.
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

Other Name: Recombinant Humanized Anti-CD52 Mab




Primary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: up to 1 year ]

    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 :
  1. Progression-Free Survival [ Time Frame: up to 1 year ]
    Progression-Free Survival was defined as the time from randomization to disease progression (PD) or death due to any cause, whichever comes first.

  2. Disease Control Rate(DCR) [ Time Frame: up to 1 year ]

    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


  3. Duration of Response(DOR) [ Time Frame: up to 1 year ]
    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.

  4. Overall Survival [ Time Frame: up to 1 year ]
    Overall Survival was defined as the duration from randomization to death due to any cause.

  5. Summary of patients with Adverse Events(AEs) [ Time Frame: up to 1 year ]
    Analysis of patients with adverse experiences according to CTCAE Version 4.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982175


Contacts
Contact: Jing Li, M.D. 86-21-60129260 lijing@cmablab.org
Contact: Jun Yan, M.D. 86-21-60129299 ext 8629 yanjun@cmablab.org

Locations
China, Beijing
Peking University Cancer Hospital Recruiting
Peking, Beijing, China
Contact: Jun Zhu, M.D.    86-10-88196596    zj@bjcancer.org   
Sponsors and Collaborators
Shanghai Zhangjiang Biotechnology Limited Company
Investigators
Study Chair: Jun Zhu, M.D. Beijing Cancer Hospital

Responsible Party: Shanghai Zhangjiang Biotechnology Limited Company
ClinicalTrials.gov Identifier: NCT01982175     History of Changes
Other Study ID Numbers: CMAB004
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Shanghai Zhangjiang Biotechnology Limited Company:
Alemtuzumab
B-cell chronic lymphocytic leukemia
CD52

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alemtuzumab
Antineoplastic Agents