Neoplasms

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Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Alemtuzumab

Antineoplastic Agents, Immunological

Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated).

Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered subcutaneously at alternating injection sites 3 times per week for up to 18 weeks.

Alemtuzumab is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg, 10mg, and 30mg administered subcutaneously (SC) (if tolerated). When escalation to 30 mg is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 18 weeks.

Part 1 of the study: The first 20 patients will be randomized to either Arm 1 (dose escalation) or Arm 2 (no escalation). Part 1 of the study has been completed; no additional patients will be enrolled in Part 1. An assigned review panel has reviewed the safety data from Part 1 and determined that all patients will be enrolled and treated under a no escalation schedule for Part 2 of the study.

Alemtuzumab treatment is started immediately at the 30mg dose (with no escalation period), administered SC at alternating injection sites 3 times per week for up to 18 weeks.

Part 2 of the study: All patients are currently being enrolled under the no escalation schedule for Part 2 of the study. All patients in Part 2 will be treated with 30mg of alemtuzumab (with no escalation period) administered SC (at alternating injection sites) 3 times per week (e.g., Monday, Wednesday, Friday) for up to 18 weeks. Alemtuzumab is to be administered in a supervised medical setting on an outpatient basis for the first three weeks, after which some study centers may allow a home administration option, with one weekly clinic visit. Under the home administration option, alemtuzumab may be administered by the patient or care giver if the patient meets conditions specified in the protocol guidelines for home administration.

Medical Monitor

This is a Phase II, open-label, prospective, multicenter study to evaluate the efficacy and safety of subcutaneously administered alemtuzumab (CAMPATH, MabCampath) as therapy for patients with relapsed or refractory B-CLL who have been previously treated.

Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia

A Phase II Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Alemtuzumab (CAMPATH®, MabCampath®) in Patients With Previously Treated B-Cell Chronic Lymphocytic Leukemia

Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.

Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The percentage of participants whose best response observed during the study was either a Complete Response (CR) or a Partial Response (PR). Overall Response (OR) = CR + PR. A Complete Response (CR) exhibits a normal physical exam, marrow cells and blood values. A Partial Response (PR) has a \>= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam.

Progression-free survival was defined as the number of days from the date of first treatment to the date of first objective documentation of progressive disease (PD) as determined by the IRRP, or death due to any cause. Results are expressed in months.

Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.

Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease (PD) as determined by IRRP or death due to any cause. Results are stated in months.

Progressive Disease (PD) was defined as an increase in size/number of nodes, size of liver or spleen, increase in lymphocytes, or aggressive histology.

Overall survival was defined as the time in days from the date of first treatment to the date of death due to any cause for all participants. Results are stated in months.

MRD negativity represents a very positive response outcome. MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. All patients are evaluated for treatment response based on National Cancer Institute Working Group (NCIWG) criteria. Of patients who have achieved a clinical complete response (CR) or partial response (PR) that met National Cancer Institute Working Group (NCIWG) criteria of CR except blood recovery, a bone marrow sample was taken for flow cytometry measure of MRD negativity.

Number of participants with treatment-emergent adverse events (TEAEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (5 point scale from 'not related' to 'definitely related') and severity (5 point scale with grade 5 being most severe). Categories reported include participant counts for treatment-emergent AEs, injection site reactions, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), deaths and severity.

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Genzyme, a Sanofi Company

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Events are listed independent of relationship to treatment reported.

Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.

Alemtuzumab 30mg

Age, Continuous

Sex: Female, Male

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Other

Race/Ethnicity, Customized

Rai Stage 0

Rai Stage I

Rai Stage II

Rai Stage III

Rai Stage IV

Rai staging is a way to categorize the disease progression of chronic lymphocytic leukemia (CLL); higher stages reflect increasing severity. Data represents the Rai Stage when the participant entered the study.

Rai Stage 0: Lymphocytosis only, Rai Stage I: Lymphocytosis and lymphadenopathy, Rai Stage II: Lymphocytosis and hepatomegaly +/- splenomegaly, Rai Stage III Lymphocytosis with anemia, Rai Stage IV Lymphocytosis with thrombocytopenia

Current Rai Stage

Stage A

Stage B

Stage C

Binet staging is another way to categorize chronic lymphocytic leukemia (CLL). Data represents the Binet Stage when the participant entered the study.

Stage A CLL is characterized by no anemia or thrombocytopenia and fewer than three areas of lymphoid involvement (Rai stages 0, I, and II).

Stage B CLL is characterized by no anemia or thrombocytopenia with three or more areas of lymphoid involvement (Rai stages I and II).

Stage C CLL is characterized by anemia and/or thrombocytopenia regardless of the number of areas of lymphoid enlargement (Rai stages III and IV).

Current Binet Stage

The WHO performance status classification categorises patients as:

0: able to carry out all normal activity without restriction

1. restricted in strenuous activity but ambulatory and able to carry out light work
2. ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours

World Health Organization (WHO) Performance

Genzyme Medical Information

Overall response (CR+PR)

Complete response (CR)

Partial response (PR)

Stable disease (SD)

Progressive disease (PD)

Not Evaluable (NE)

Number of Participants With Best Disease Response as Determined by the Independent Response Review Panel (IRRP)

Kaplan-Meier Estimates of Progression Free Survival as Determined by the Independent Response Review Panel (IRRP)

Participants who had a complete response or a partial response

Kaplan-Meier Estimates of Duration of Response as Determined by the Independent Response Review Panel (IRRP)

Kaplan-Meier Estimates of Overall Survival

Participants With a Minimal Residual Disease (MRD) Status of Negative

>=1 TEAE

>=1 TEAE related to drug

>=1 injection site reaction

>=1 injection site reaction related to drug

>=1 infection

>=1 infection related to drug

>=1 serious AE

>=1 serious AE related to drug

Discontinued study drug due to AE

Discontinued study drug due to related AE

Deaths

Deaths within 30 days of last dose

TEAE with worst severity grade 1

TEAE with worst severity grade 2

TEAE with worst severity grade 3

TEAE with worst severity grade 4

TEAE with worst severity grade 5

Participants With Treatment-Emergent Adverse Events (TEAE)

Full analysis set. 95% confidence interval calculated using exact binomial method.

Percentage of Participants Who Had an Overall Response (OR) as Determined by the Independent Response Review Panel (IRRP)

Treatment

Follow-up

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Immunoglobulins

Lenograstim

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Adjuvants, Immunologic

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4

CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab

CHOP14 chemotherapy (see specification under Arm B) plus G-CSF

Francesco d'Amore, Prof

The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.

First International phase III T-cell lymphoma study Indication:Newly diagnosed non-cutaneous peripheral T-cell lymphoma Study objectives:Determination of the efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with two-weekly CHOP supported by G-CSF Primary Endpoint: Event-Free-Survival (EFS) Study Design: International open-label, multicentre, randomized Phase III Study

Study Medication: Patients are randomized to six cycles of two-weekly CHOP plus G-CSF with or without alemtuzumab given subcutaneously 30 mg day 1 in combination with chemotherapy cycles 1-4. Patients in CR, CRu and PR after the 6 cycles of CHOP14 combined or not with alemtuzumab will receive a consolidation with high-dose chemotherapy followed by autologous stem cell transplantation.

Patient Population: Patients \> 18 yrs with newly diagnosed non-cutaneous, non-leukemic PTCL, except alk-protein positive and negative anaplastic large cell lymphoma Planned Sample Size: 308 young patients (18-60 yrs) registered and randomized Total Number of Centers: This study will be proposed to main European and Australian Study Groups.

Alemtuzumab and CHOP in T-cell Lymphoma

A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and Consolidated by Autologous Stem Cell Transplant, in Young Patients With Previously Untreated Systemic Peripheral T-cell Lymphomas

GCP-unit at Aarhus University Hospital, Aarhus, Denmark

Aarhus University Hospital

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, T-Cell

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Neoplasm, Residual

Leukemia-Lymphoma, Adult T-Cell

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Adult T-cell Leukemia/lymphoma

Cladribine

In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added.

In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation.

Alemtuzumab (MabCampath)

Dieter Hoelzer, MD, PhD

This study tests the effectivity and tolerability of treatment with alemtuzumab (MabCampath) in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma. In Arm A, patients with refractory relapse receive a 2 week treatment with MabCampath followed by remission evaluation. In case of insufficient response, treatment with cladribine is added. In Arm B, patients with molecular relapse (minimal residual disease) receive a 4 week treatment with MabCampath followed by remission evaluation. In both arms, treatment is continued in case of response for up to two months.

Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath

German Multicenter Phase II Trial to Study Effectivity and Feasibility of Alemtuzumab (MabCampath®) in T-ALL and T-Lymphoblastic Lymphomas With Minimal Residual Disease (MRD), in Refractory Relapse or in Primary Failure

Goethe University

Head of GMALL

Campath is administered using escalating doses and alternating injection sites. The dose is escalated as tolerated using 3mg,10mg,and 30mg, administered subcutaneously (SC) (if tolerated). When escalation to 30 mg dose is tolerated, all subsequent doses are administered at 30 mg SC 3 times per week at alternating injection sites for up to 8 weeks

Alemtuzumab (Campath-1H)

Thomas Kipps, MD, PhD

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will: a) eliminate minimal residual disease (documented by flow cytometry) in patients who have achieved a complete remission (CR) or b) convert partial remission to complete remission.

To evaluate the time-to-progression of patients according to pretreatment characteristics and response status at study entry.

To evaluate whether CAMPATH-1H given to patients with CLL after maximum response to chemotherapy will eliminate minimal residual disease as determined by real-time quantitative PCR.

Approximately 95% of cases involve the clonal proliferation of B cells. Paraproteins, often of the IgM class, can be detected in the serum and/or urine of most patients with CLL. Unique cell surface markers are increasingly being used to diagnose the disease, and in approximately 40% of patients, cytogenetic abnormalities (for example, trisomy 12) can be found. Patients commonly present with lymphocytosis, lymphadenopathy, splenomegaly and symptoms of fatigue, weight loss, and malaise. In more advanced cases anemia and thrombocytopenia can also occur. The clinical course of CLL is unpredictable, with survival from initial diagnosis varying from 1 to 20 years (2). In addition, there is a subset of patients with indolent CLL whose absolute lymphocyte count is less than 30 x 109/L and who rarely die from the disease.

CLL is commonly staged according to the 5-point system proposed by Rai (Appendix B) and co-workers. While Rai staging is a relatively good predictor of overall survival, it cannot predict the prognosis in individual patients.

Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy

A Clinical Research Consortium (CRC) Phase II Study of Subcutaneous Campath-1H in Patients With B-Cell Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy

Bayer

Chronic Lymphocytic Leukemia Research Consortium

Thomas J. Kipps, M.D., Ph.D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Subcutaneous Alemtuzumab (CAMPATH®, MabCampath®) in Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia	NCT00328198	B-Cell Chronic ...	Alemtuzumab Alemtuzumab	18 Years -	Sanofi
Alemtuzumab and CHOP in T-cell Lymphoma	NCT00646854	Lymphoma, T-Cel...	CHOP14 chemothe... CHOP14 chemothe...	18 Years - 60 Years	University of Aarhus
Treatment of Relapsed T-cell Acute Lymphoblastic Leukemia or T-lymphoblastic Lymphoma With MabCampath	NCT00199030	Adult Acute Lym... Lymphoma, Lymph...	Alemtuzumab (Ma... Cladribine	18 Years -	Goethe University
Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy	NCT00800943	B-Cell Chronic ...	Alemtuzumab (Ca...	18 Years -	Chronic Lymphocytic Leukemia Research Consortium
Study of Subcutaneous Campath-1H in Patients With B-Cell CLL and Residual Disease After Chemotherapy	NCT00800943	B-Cell Chronic ...	Alemtuzumab (Ca...	18 Years -	Chronic Lymphocytic Leukemia Research Consortium

Spots Global Cancer Trial Database for mabcampath

Every month we try and update this database with for mabcampath cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mabcampath

Every month we try and update this database with for mabcampath cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mabcampath cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.