Clinical trial NCT01982175: Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia
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
Overall status: SUSPENDED
Phase: PHASE2
Conditions: B-cell Chronic Lymphocytic Leukemia
Keywords: Alemtuzumab
B-cell chronic lymphocytic leukemia
CD52
Lead sponsor: Shanghai Zhangjiang Biotechnology Limited Company
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: up to 1 year
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: up to 1 year
measure: Disease Control Rate(DCR)
timeFrame: up to 1 year
measure: Duration of Response(DOR)
timeFrame: up to 1 year
measure: Overall Survival
timeFrame: up to 1 year
measure: Summary of patients with Adverse Events(AEs)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, M.D.
role: STUDY_CHAIR
References: