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Withdrawn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 : November 8, 2018
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Primary Objective:
To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma.
Secondary Objectives:
- To determine the duration of response and time to progression after Campath-1H therapy in this patient population.
- 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 |
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Hodgkin's Disease Lymphoma | Drug: Alemtuzumab (Campath-1H) | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
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 |
Actual Study Start Date : | June 22, 2005 |
Actual Primary Completion Date : | September 5, 2006 |
Actual Study Completion Date : | September 5, 2006 |

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:
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- Response Rate [ Time Frame: 1 Year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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%.

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
Principal Investigator: | Anas Younes, M.D. | UT MD Anderson Cancer Center |
Responsible Party: | Anas Younes, M.D. / Professor, UT MD Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00129753 |
Other Study ID Numbers: |
2004-0742 |
First Posted: | August 12, 2005 Key Record Dates |
Last Update Posted: | November 8, 2018 |
Last Verified: | November 2018 |
Campath-1H Monoclonal Antibody Alemtuzumab Campath |
Campath-1H Relapsed and Resistant Classical Hodgkin's Disease Lymphoma |
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Alemtuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |