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Alemtuzumab

Phase 2

Leukemia | Monoclonal antibody | Oncology |Bayer AG|Last Updated: Nov 6, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Alemtuzumab · 2 trials · 1 indication

Phase 2 2
NCT00858117A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLLLeukemia
COMPLETED30 Analytics
NCT00086775Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic LeukemiaLeukemia
COMPLETED- Analytics
PHASE2COMPLETED
A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL
LeukemiaUnlock trial analytics
PHASE2COMPLETED
Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia
LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination
At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

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

Number of Patients Treated With Alemtuzumab and Rituximab Combination With Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans
At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

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.

Secondary Endpoints

Toxicity of the Study Medications, Alemtuzumab and Rituximab
During treatment, 18 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Alemtuzumab and RituximabEXPERIMENTALAdministration 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.

Interventions

NameTypeDescription
AlemtuzumabBIOLOGICALAlemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks
RituximabBIOLOGICALRituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks
fludarabine phosphateDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:United States
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Competitive Landscape -Leukemia 327 trials

Top 20 of 63 competitors

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Blinatumomab, Low-intensity chemotherapy regimen
Eli Lilly and CompanyLLY9PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab
BeOne Medicines Ltd. Sponsored ADRONC13PHASE3Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab
AbbVie, Inc.ABBV24PHASE3Venetoclax
AstraZeneca PLCAZN18PHASE3Acalabrutinib, Rituximab, Chlorambucil
Merck & Co., Inc.MRK7PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
Johnson & JohnsonJNJ12PHASE3Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab
Novartis AG Sponsored ADRNVS21PHASE3Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
Kura Oncology, Inc.KURA5PHASE3Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine
Nurix Therapeutics, Inc.NRIX5PHASE3NX-5948, Pirtobrutinib
Syndax Pharmaceuticals IncSNDX4PHASE3Revumenib, Intensive Chemotherapy Regimen
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Ponatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine
SELLAS Life Sciences Group, Inc.SLS1PHASE3Galinpepimut-S, Azacitidine, Venetoclax, Decitabine, Cytarabine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
Bristol-Myers Squibb CompanyBMY7PHASE2Azacitidine
Pfizer Inc.PFE6PHASE2Gemtuzumab ozogamicine- Cytarabine- Gilteritinib
Ascentage Pharma Group International Unsponsored ADRAAPG11PHASE3Olverembatinib
Tango Therapeutics, Inc.TNGX7PHASE3AG-120, Azacitidine
Incyte CorporationINCY6PHASE2Ruxolitinib
Actinium Pharmaceuticals, Inc. (Delaware)ATNM2PHASE3Iomab-B, Conventional Care
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Frequently asked questions about Alemtuzumab

What is Alemtuzumab used for in Leukemia?

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.

What does Alemtuzumab target?

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.

Who makes Alemtuzumab?

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.

What phase is Alemtuzumab in?

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.

What clinical trials is Alemtuzumab in?

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.

Is Alemtuzumab the same as Campath?

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.