|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 15, 2008 | ||||
| Last Updated Date | June 9, 2009 | ||||
| Start Date ICMJE | February 2003 | ||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Toxicity by NCI CTCAE criteria [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00601380 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Anti-CD45 Monoclonal Antibody, Cytarabine, Cyclophosphamide, and Total-Body Irradiation With or Without Alemtuzumab in Treating Patients Undergoing a Donor Stem Cell Transplant For Advanced Leukemia or Other Hematologic Cancer | ||||
| Official Title ICMJE | PHASE I/II STUDY OF ANTI-HUMAN CD45 MONOCLONAL ANTIBODIES IN PATIENTS WITH ADVANCED LEUKEMIA PRIOR TO ALLOGENEIC STEM CELL TRANSPLANTATION | ||||
| Brief Summary | RATIONALE: Giving anti-CD45 monoclonal antibody, alemtuzumab, chemotherapy, and radiation therapy before a donor peripheral blood stem cell transplant or bone marrow stem cell transplant helps stop the growth of cancer cells and stops the patient's immune system from rejecting the donor's stem cells. Donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). PURPOSE: This phase I trial is studying the side effects of giving anti-CD45 monoclonal antibody together with cytarabine, cyclophosphamide, and total-body irradiation with or without alemtuzumab followed by a donor stem cell transplant and to see how well it works in treating patients with relapsed or resistant leukemia or other hematologic cancer. |
||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE:
|
||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | up to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00601380 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000582390, BCM-H-12870, BCM-ADVL | ||||
| Study Sponsor ICMJE | Baylor College of Medicine | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||