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Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia
This study is currently recruiting participants.
Verified by Genzyme, December 2007
Sponsors and Collaborators: Genzyme
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00328198
  Purpose

This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered CAMPATH as therapy for patients with relapsed or refractory B-CLL who have been previously treated.


Condition Intervention Phase
B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Biological: Alemtuzumab (CAMPATH, MabCampath)
Biological: alemtuzumab (Campath, MabCampath)
Biological: alemtuzumab (Campath® / MabCampath®)
Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Alemtuzumab Campath
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Determine best disease response to CAMPATH treatment administered subcutaneously for up to 18 weeks in patients with B-Cell Chronic Lymphocytic Leukemia (B-CLL) who have been previously treated. [ Time Frame: 44 weeks with additional observation period thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival (PFS). [ Time Frame: 44 weeks with additional observation period thereafter ] [ Designated as safety issue: No ]
  • Duration of response. [ Time Frame: 44 weeks with additional observation period thereafter ] [ Designated as safety issue: No ]
  • Overall survival. [ Time Frame: 44 weeks with additional observation period thereafter ] [ Designated as safety issue: No ]
  • Minimal residual disease (MRD) status by flow cytometry analysis of bone marrow and peripheral blood. [ Time Frame: 44 weeks with additional observation period thereafter ] [ Designated as safety issue: No ]
  • To evaluate the safety of CAMPATH administered subcutaneously. [ Time Frame: 44 weeks with additional observation period thereafter ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 85
Study Start Date: May 2006
Estimated Study Completion Date: January 2010
Arms Assigned Interventions
Part 1 - Arm 1: Experimental
Campath with dose escalation
Biological: Alemtuzumab (CAMPATH, MabCampath)
Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks
Part 1 - Arm 2: Experimental
Campath without dose escalation
Biological: alemtuzumab (Campath, MabCampath)
Campath treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks
part 2: Experimental
Campath either with escalation or without escalation depending on the outcome of Part 1
Biological: alemtuzumab (Campath® / MabCampath®)
An assigned review panel will review the data from part 1 to determine whether escalation or no escalation is the recommended schedule. All patients will then be enrolled into the recommended schedule (arm). CAMPATH is to be administered in a supervised medical setting on an outpatient basis for the first three weeks. After which some study centers may allow a home administration option where CAMPATH may be administered by patient or care giver if patients meet conditions specified in the protocol guidelines for home administration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of B-CLL; according to the NCI WG Criteria.
  • WHO performance status of 0, 1, or 2.
  • Life expectancy ≥ 12 weeks.
  • Previous therapy with at least one but no more than 5 regimens (single agent or combination regimen). One therapy regimen is defined as consecutive, contiguous cycles of the same drug(s) with no treatment interruptions lasting > 3 months.
  • Patient requires treatment for CLL per the following criteria: -Rai stage III or IV; -Rai stage 0-II with at least one of the following - evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia; Massive (i.e. greater than 6 cm below the left costal margin) or progressive splenomegaly; Progressive lymphocytosis with an increase of greater than 50% over a 2-month period or an anticipated doubling time of less than 6 months; Lymphocyte count > 100 x 10^9/L; B symptoms.
  • More than 3 weeks since prior chemotherapy. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
  • More than 3 weeks since using investigational agents. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
  • Serum creatinine and conjugated (direct) bilirubin less than or equal to 2 x the institutional upper limit of normal (ULN) unless secondary to direct infiltration of the liver with CLL.
  • Female patients with childbearing potential must have a negative pregnancy test (serum or urine) within 2 weeks of first dose of study drug(s). All patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy.
  • Signed, written informed consent (in the US, includes HIPPA authorization)

Exclusion Criteria:

  • Positive Coombs test and evidence of active hemolysis.
  • Platelet count less than 50 x 10^9/L without splenomegaly.
  • History of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanized monoclonal antibodies.
  • Previously treated with CAMPATH.
  • Previous bone marrow transplant.
  • Known central nervous system (CNS) involvement with B-CLL
  • Active infection, including human immunodeficiency virus (HIV) positive.
  • Active secondary malignancy.
  • Recent documented history (within 2 years) of active tuberculosis (TB), current active TB infection, currently receiving anti-tuberculosis medication (e.g., INH, rifampin, streptomycin, pyrazinamide, or others).
  • 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)).
  • Other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental disorders, or major organ malfunction (liver, kidney) that could interfere with the patient ability to participate in the study.
  • Pregnant or nursing women.
  • CMV positive by PCR (above the level of detection). A patient that is PCR positive will require treatment to reduce the viral load to a non-detectable level; but such a patient may be considered for study entry once the infection has been treated.
  • Medical condition requiring chronic use of oral corticosteroids at a dose higher than physiologic replacement.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328198

Contacts
Contact: Medical Information 800-745-4447 Medinfo@genzyme.com
Contact: Medical Information 617-252-7832 Medinfo@genzyme.com

  Show 33 Study Locations
Sponsors and Collaborators
Genzyme
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
  More Information

US FDA Approved Full Prescribing Information for Campath®  This link exits the ClinicalTrials.gov site

Responsible Party: Genzyme ( Medical Monitor )
Study ID Numbers: CAM203
Study First Received: May 18, 2006
Last Updated: February 25, 2008
ClinicalTrials.gov Identifier: NCT00328198  
Health Authority: United States: Food and Drug Administration;   Belgium: Federal Public Service: Health, Food Chaine Safety, and Environment;   Czech Republic: State Institute for Drug Control;   France: Agence Francaise de Securite Sanitaire des Produits de Sante (AFDDAPS) - French Health Products Safety Agency;   Serbia and Montenegro: Agency for Drugs and Medicinal Devices;   United Kingdom: MRHA

Keywords provided by Genzyme:
CAMPATH
Alemtuzumab
Leukemia
MabCampath
Chronic
Subcutaneous
CLL
C-CLL
Relapsed
Refractory
Chronic Lymphocytic Leukemia

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009