Approval Probability
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Adjusted LOA
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Alemtuzumab · 2 trials · 1 indication
Response rate (complete remission(CR) + partial remission(PR)) will be, assessed by NCI-WG 1996 criteria with lymphadenopathy and organomegaly measured during physical examination. CR=Absence of lymphadenopathy and constitutional symptoms, Normal CBC (leukocytes ≥ 1500/μl, Platelets \>100,000/μl, Hemoglobin \> 11.0 gm/dl), peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes. PR=absence of constitutional symptoms, ≥ 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, ≥ 50% reduction in lymphadenopathy, ≥ 50% reduction in size of liver and/or spleen and one of the following: polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline platelets \> 100,000/μl or 50% improvement over baseline or hemoglobin \> 11.0 gm/dl or 50% improvement over baseline without transfusions
Response rate (complete remission(CR) + partial response(PR)) will be assessed by NCI-WG 1996 criteria with measurements of the lymph nodes and spleen size by CT scans. Best response at any timepoint is captured below. CR= absence of significant lymphadenopathy (e.g. lymph nodes \> 1.5 cm in their greatest transverse diameter) and no hepatomegaly or splenomegaly. PR=reduction in lymphadenopathy as defined by the following: (a) a decrease in lymph node size by 50% or more either in the sum products of up to six lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy; (b) no increase in any lymph node, and no new enlarged lymph node; in small lymph nodes (\< 2cm), an increase of less than 25% was not considered to be significant and a reduction in the noted pretreatment enlargement of the spleen or liver by 50% or more.
| Arm | Type | Description |
|---|---|---|
| Alemtuzumab and Rituximab | EXPERIMENTAL | Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. |
| Name | Type | Description |
|---|---|---|
| Alemtuzumab | BIOLOGICAL | Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks |
| Rituximab | BIOLOGICAL | Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks |
| fludarabine phosphate | DRUG | - |
DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL)\*, as defined by the following criteria: * Peripheral blood absolute lymphocyte count \> 5,000/mm³ * Small- to moderate-size lymphocytes with \< 55% prolymphocytes, atypical lymphocytes, or lymphoblasts * Pheno...
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Alemtuzumab is a monoclonal antibody being studied for the treatment of leukemia, specifically B-cell chronic lymphocytic leukemia (CLL). It is currently in Phase 2 clinical development and is being investigated in combination with other agents such as fludarabine or rituximab for patients with refractory, relapsed, or previously untreated CLL.
Alemtuzumab is a monoclonal antibody that targets the CD52 antigen, which is present on the surface of mature lymphocytes, including malignant B-cells in chronic lymphocytic leukemia. By binding to CD52, it induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity, leading to the destruction of leukemia cells.
Alemtuzumab is being developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer AG is listed on the stock exchange under the ticker symbol BAYRY. The drug is currently in Phase 2 clinical trials for the treatment of leukemia.
Alemtuzumab is currently in Phase 2 clinical development for the treatment of leukemia. It is an investigational drug and has not yet been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, with a total enrollment of 30 patients.
Alemtuzumab has been studied in two completed Phase 2 clinical trials. NCT00086775 evaluated fludarabine combined with either alemtuzumab or rituximab in patients with refractory or relapsed B-cell chronic lymphocytic leukemia. NCT00858117 assessed alemtuzumab and rituximab in patients with previously untreated CLL. Both trials were conducted in the United States.
Alemtuzumab is the generic name for the drug that was previously marketed under the brand name Campath. However, the information provided here does not specify whether the drug is currently marketed under that name. In the context of the clinical trials described, it is referred to as alemtuzumab.