A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia - Full Text View

Purpose

The primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg (the US/European Union (EU) approved dose) in Japanese patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).

Condition	Intervention	Phase
Leukemia, Lymphocytic, Chronic, B-Cell	Drug: alemtuzumab	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Alemtuzumab

Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Safety profile: As measured by physical examinations, vital signs, adverse events, concomitant medications and laboratory tests [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall response rate: Defined as the proportion of patients who achieved complete remission (CR) or partial remission (PR) as the best response according to the investigator's determination using the NCIWG response criteria [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
Pharmacokinetic profiles: Area under the serum concentration vs time curve over the dosing interval, Maximum drug concentration in serum, terminal elimination half-life following the last dose, total body clearance and volume of distribution [ Time Frame: until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
Time to response: Defined as the time from date of initial treatment until first objective documentation of response (CR or PR) as determined by the investigator. [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
If a patient achieves PR before CR, the onset date of PR will be used in the calculation
Duration of response: Defined as the time from first objective documentation of response (CR or PR) by the investigator to first objective documentation of progressive disease by the investigator [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
Time to progression: Defined as the time from date of initial treatment to first objective documentation of progressive disease by the investigator [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]


Enrollment:	6
Study Start Date:	February 2010
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Alemtuzumab The starting dose of alemtuzumab was 3 mg. The dose was gradually escalated on a daily basis (3 mg, 10 mg, and then 30 mg) until the patient tolerated a dose of 30 mg IV infusion over 2 hours. All subsequent doses of alemtuzumab were 30 mg IV 3 times a week (every other day).	Drug: alemtuzumab Other Name: MabCampath, BAY86-5045, CAMPATH-1H

Detailed Description:

NOTE: This study was previously posted by Bayer. In December 2009, this study was acquired by Genzyme Corporation. Genzyme Japan K.K. is the sponsor of the trial.

Eligibility


Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

B-cell Chronic Lymphocytic Leukemia (B-CLL) according to the 1996 National Cancer Institute-sponsored Working Group (NCI-WG) Criteria
One or more, but <= 3 previous treatment regimens for Chronic Lymphocytic Leukemia (CLL)
Patient requires treatment for CLL (Rai stage III and IV disease or stage 0 to II disease with evidence of progression)
Adequate bone marrow, liver and renal function
More than 4 weeks since prior chemotherapy or chemoimmunotherapy, including investigational agents, for the treatment of CLL. Patient must have recovered from the acute side effects incurred as a result of previous therapy
World Health Organization (WHO) Performance Status (PS) 0,1
Life expectancy of at least 24 weeks
Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 2 weeks after the completion of trial
Written informed consent

Exclusion Criteria:

Known human immunodeficiency virus (HIV) seropositivity
Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies. Patients with a positive hepatitis B surface antibody (HBsAb) test with a documented history of prior hepatitis B immunization are eligible as long as other criteria are met (i.e., negative tests for : hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb] and hepatitis C virus antibody [HCVAb])
Active uncontrolled infection
Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti-tuberculous medication (e.g., isoniazid, rifampin, streptomycin, pyrazinamide, or others)
Positive cytomegalovirus (CMV) by Polymerase Chain Reaction (PCR) assay
Transformation to aggressive lymphoma (e.g., Richter's syndrome)
Past history of anaphylaxis following exposure to humanized monoclonal antibodies
Previous treatment with alemtuzumab
Previous hematopoietic stem cell transplant
Pregnant or breast-feeding patients
Central nervous system (CNS) involvement with CLL
Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental disorders, or major organ malfunction (e.g., liver, kidney) that could interfere with the patient's ability to participate in the study
Medical condition requiring chronic use of oral corticosteroids at a dose higher than physiologic replacement.
Active malignancy, other than CLL, which needs therapy with anti-cancer drug(s)
Autoimmune anemia and/or thrombocytopenia
Small lymphocytic lymphoma

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923182

Locations


Japan

Nagoya, Aichi, Japan, 466-8650

Tsukuba, Ibaraki, Japan, 305-8576

Sendai, Miyagi, Japan, 980-8574

Bunkyo-ku, Tokyo, Japan, 113-8519

Chuo-ku, Tokyo, Japan, 104-0045

Chiba, Japan, 260-8677

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators


Study Director:	Medical Monitor	Genzyme, a Sanofi Company

More Information


Responsible Party:	Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:	NCT00923182 History of Changes
Other Study ID Numbers:	CAMCLL07709 14020
Study First Received:	June 9, 2009
Last Updated:	April 29, 2015
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:


Relapsed or Refractory Chronic Lymphocytic Leukemia, CLL

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

ClinicalTrials.gov processed this record on September 26, 2016