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Completed

NCT Number: NCT00923182

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

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).

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alemtuzumab

Drug

Other names: MabCampath, BAY86-5045, CAMPATH-1H

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

    If a patient achieves PR before CR, the onset date of PR will be used in the calculation

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 18, 2009
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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