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recruiting difficulties
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This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alemtuzumab | Experimental | Patients receive Alemtuzumab escalated from initial dose of 3mg/day then 10mg/day and up to 30mg/day by intravenous infusion(if tolerated). when stable dose of 30mg/day is tolerated, Alemtuzumab is administrated at 30mg by IV infusion 3 times per week for up to 12 weeks (including escalation and stable dose period). After completion of 12 weeks treatment, or discontinuation of treatment within 12 weeks due to disease progression, patients will be visited every 3 months up to 1 year from enrollment or to death, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab | Biological | Escalation Phase: Initial Doses of Alemtuzumab 3mg/day by intravenous(IV) infusion until tolerated, then Alemtuzumab 10mg/day IV infusion until tolerated, then Alemtuzumab 30mg IV infusion until tolerated. Escalation to 30mg/day should be accomplished in 3~7 days. Stable dose Phase: Once 30mg/day infusion of Alemtuzumab was tolerated, then continue 3 times per week. The total duration of Alemtuzumab therapy including escalation and stable dose phase is 12 weeks. More than 30mg daily or 90mg weekly dose is prohibited -------------------------------------------------------------------------------- |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Objective Response Rate was defined as the proportion of patients who have CR, PR during the study as evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. Response categories include Complete Response(CR) and Partial Response(PR). ORR=CR+PR | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Progression-Free Survival was defined as the time from randomization to disease progression (PD) or death due to any cause, whichever comes first. | up to 1 year |
| Disease Control Rate(DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhu, M.D. | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Patients were evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. The best response observed during the study is summarized. Response categories include Complete Response(CR), Partial Response(PR) and Stable Disease(SD).
DCR=CR+PR+SD
| up to 1 year |
| Duration of Response(DOR) | Duration of response was analyzed for patients who achieved a complete release(CR) or partial release(PR) and was defined as the time from the first date of documented response to the date of disease progression or death due to any cause. | up to 1 year |
| Overall Survival | Overall Survival was defined as the duration from randomization to death due to any cause. | up to 1 year |
| Summary of patients with Adverse Events(AEs) | Analysis of patients with adverse experiences according to CTCAE Version 4. | up to 1 year |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |