|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 8, 2003 | ||||
| Last Updated Date | April 21, 2009 | ||||
| Start Date ICMJE | May 2003 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical response every month during treatment, monthly for 3 months, and then every 3 months for a year [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Clinical response every month during treatment, monthly for 3 months, and then every 3 months for a year | ||||
| Change History | Complete list of historical versions of study NCT00064155 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Saturation of CD52 every month during treatment, monthly for 3 months, and then every 3 months for a year [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Saturation of CD52 every month during treatment, monthly for 3 months, and then every 3 months for a year | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Alemtuzumab in Treating Patients With HTLV-1 Associated Adult T-Cell Leukemia/Lymphoma | ||||
| Official Title ICMJE | Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia | ||||
| Brief Summary | RATIONALE: Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with HTLV-1 associated adult T-cell leukemia/lymphoma. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: This is a nonrandomized study. Each patient receives escalating doses of alemtuzumab IV once daily until the target dose is reached and tolerated. Patients then receive the target dose of alemtuzumab IV over 2 hours 3 times weekly for a total of 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly until the CD4 count has recovered and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 9-29 patients will be accrued for this study within 2.5 years. |
||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Biological: alemtuzumab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 29 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00064155 | ||||
| Responsible Party | John Charles Morris, NCI - Metabolism Branch;MET | ||||
| Study ID Numbers ICMJE | CDR0000309057, NCI-03-C-0194, NCI-4553 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||