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Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease

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ClinicalTrials.gov Identifier: NCT00129753
Recruitment Status : Withdrawn (Terminated due to slow accrual.)
First Posted : August 12, 2005
Last Update Posted : April 7, 2016
Sponsor:
Information provided by:
M.D. Anderson Cancer Center

Brief Summary:

Primary Objective:

To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma.

Secondary Objectives:

  1. To determine the duration of response and time to progression after Campath-1H therapy in this patient population.
  2. To determine the effect of Campath-1H on serum IL-6, IL-10, and IL-13 levels in patients with relapsed and resistant classical Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Hodgkin's Disease Lymphoma Drug: Alemtuzumab (Campath-1H) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
Study Start Date : June 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hodgkin Disease
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Alemtuzumab Drug: Alemtuzumab (Campath-1H)
Escalating dose 3mg, 10 mg, 30 mg on three consecutive days, then 30 mg three times per week by subcutaneous injections for 12 weeks. Each 30 mg dose will be divided in 2 injections to be administered in each thigh.
Other Names:
  • Campath
  • Campath-1H
  • Campath-1H Monoclonal Antibody



Primary Outcome Measures :
  1. Response Rate [ Time Frame: 1 Year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Relapsed or refractory Hodgkin's disease with a minimum of 2 prior treatment regimens, including autologous bone marrow transplantation.
  • Must have histologically proven diagnosis of nodular sclerosis or mixed cellularity Hodgkin's disease.
  • Hodgkin's lymphoma should be limited to lymph nodes, spleen, and bone marrow.
  • Must have bi-dimensionally measurable disease defined as a lymph node at least 2 cm by computed tomography (CT) scan.
  • Platelet count equal to or greater than 50,000/uL; absolute neutrophil count equal to or greater than 1,000/uL.
  • Must sign a consent form.
  • Males or females equal to or greater than 18 years of age.
  • Patients may be taking voriconazole, itraconazole, or diflucan.

Exclusion Criteria:

  • No serious inter-current infections requiring therapy.
  • No Hodgkin-specific therapy within the last 3 weeks.
  • Pregnant women and women of childbearing potential and men of reproductive potential who are not practicing adequate contraception.
  • Lymphocyte depletion or lymphocyte predominance histology.
  • History of HIV infection.
  • Central nervous system (CNS) involvement with lymphoma including epidural disease and cord compression.
  • Prior allogeneic stem cell transplantation.
  • Patients receiving steroids within 3 weeks of registration.
  • Patients with a history of prior severe opportunistic infections that are controlled by T-cell immunity, such as pneumocystis pneumonia (PCP), herpes virus infections, mycobacterial disease, invasive mold infections or endemic fungi.
  • Patients with an ejection fraction of less than 40%.

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): NCT00129753


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Anas Younes, M.D. UT MD Anderson Cancer Center

Additional Information:
Responsible Party: Anas Younes, M.D. / Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00129753     History of Changes
Other Study ID Numbers: 2004-0742
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: October 2010

Keywords provided by M.D. Anderson Cancer Center:
Campath-1H Monoclonal Antibody
Alemtuzumab
Campath
Campath-1H
Relapsed and Resistant Classical Hodgkin's Disease
Lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Alemtuzumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents