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Slow enrollment and minimal preliminary biological and clinical efficacy.
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| Name | Class |
|---|---|
| XOMA (US) LLC | INDUSTRY |
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The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCD122 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCD122 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| to determine the maximum tolerated dose (MTD) | between study Day 1 and study Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| to characterize safety and tolerability of HCD122 at each dose level in dose escalation patients | between study Day 1 and study termination | |
| To characterize pharmacokinetics of HCD122 at each dose level in dose escalation patients | between study Day 1 and study termination |
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Inclusion Criteria:
Exclusion Criteria:
Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego StudyCoordinator:CHCD122A2101 | La Jolla | California | 92093-0658 | United States | ||
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| To characterize peripheral blood CD40 occupancy on CD5/CD19 (CLL) cells and CD5/CD19 cell depletion activity (pharmacodynamics) of HCD122 at each dose level in dose escalation patients | between study Day 1 and study termination |
| To assess preliminary anti-tumor activity of HCD122 in dose escalation patients | between study Day 1 and study termination |
| St. Francis Cancer Research Foundation |
| Beech Grove |
| Indiana |
| 46107 |
| United States |
| The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Div Of HematologicMalignancies | Baltimore | Maryland | 21231 | United States |
| OSU Medical Center/Arthur G. James Cancer Hospital StudyCoordinator:CHCD122A2101 | Columbus | Ohio | 43210 | United States |
| MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent | Houston | Texas | 77030-4009 | United States |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D007945 | Leukemia, Lymphoid |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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| ID | Term |
|---|---|
| C578314 | lucatumumab |
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