- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00773149
Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (Campath)
Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant.
The use of G-CSF is justified by a possible increase in ADCC.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients receive Alemtuzumab in 3 successive phases:
Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.
Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.
Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75012
- Saint Antoine Hospital, Hematology Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients older than 15 years
- Refractory ALL
- ALL in relapse post chemotherapy or post transplant
- ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease.
- Signed informed consent
- Patients under social security coverage
- Anti conceptional tablets in pre menopausal women.
Exclusion Criteria:
- Children below 15 years of age or aged 15
- Blast cells not expressing CD52 antigen (at all evaluations)
- HIV positivity
- ECOG Score 3 and 4
- Hypersensitivity to Alemtuzumab.
- Pregnancy or breast feeding.
- Other malignant disease in addition to ALL.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
all included patients
|
All patients receive Alemtuzumab in 3 successive phases: Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance. Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented. Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Partial and complete remission, overall response rates
Time Frame: At 2 years
|
At 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification.
Time Frame: At 2 years
|
At 2 years
|
Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.
Time Frame: at 2 years
|
at 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Norbert Claude GORIN, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P051003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Lymphocytic Leukemia
-
Eastern Cooperative Oncology GroupCompletedAdult Patients (Over 55) With Acute Non-Lymphocytic Leukemia
-
Stanford UniversityTerminatedLeukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)United States
-
Daiichi Sankyo, Inc.TerminatedLeukemia, Myeloid, Acute | Leukemia, Lymphocytic, AcuteUnited States
-
University of MinnesotaChildren's Cancer Research Fund United StatesTerminatedLymphoblastic Lymphoma | Brain Tumors | Lymphoblastic Leukemia, Acute, Childhood | Lymphoblastic Leukemia | Leukemia, Lymphocytic, Acute | Leukemia, Lymphoblastic, Acute | Brain Neoplasms, Malignant | ALL, Childhood | Leukemia, Lymphoblastic, Acute, Philadelphia-Positive | Lymphoblastic Leukemia, Acute | Leukemia... and other conditionsUnited States
-
Genzyme, a Sanofi CompanyCompletedSolid Tumors | Leukemia, Myelocytic, Acute, Pediatric | Leukemia, Lymphocytic, Acute, Pediatric | Leukemia, Lymphocytic, Acute, Adult | Leukemia, Myelocytic, Acute, Adult | Myelodysplastic Syndromes, AdultUnited States
-
First Affiliated Hospital of Wenzhou Medical UniversitySecond Affiliated Hospital of Nanchang University; Hrain Biotechnology Co.,...UnknownHematopoietic/Lymphoid Cancer | Adult Acute Lymphoblastic Leukemia in Remission | B-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | B-cell Adult Acute Lymphoblastic LeukemiaChina
-
Sidney Kimmel Comprehensive Cancer Center at Johns...CompletedAcute Lymphoblastic Leukemia | Acute Myelogenous Leukemia (AML) | Acute Lymphocytic Leukemia (ALL) | Acute Promyelocytic Leukemia (APL)United States
-
Goethe UniversityCompletedAdult Acute Lymphocytic LeukemiaGermany
-
Shanxi Province Cancer HospitalShanghai Ultra-T Immune Therapeutics Co. LTDRecruitingAcute Lymphocytic Leukemia, B-CellChina
-
Proacta, IncorporatedUnknownAcute Lymphocytic Leukemia | Acute Myelogenous LeukemiaUnited States
Clinical Trials on Alemtuzumab (CAMPATH 1H) associated to G-CSF
-
M.D. Anderson Cancer CenterWithdrawnLymphoma | Hodgkin's Disease
-
Northwestern UniversityGenzyme, a Sanofi Company; Millennium Pharmaceuticals, Inc.Completed
-
M.D. Anderson Cancer CenterLeudositeTerminatedLymphoma, B-Cell | Lymphoma, T-Cell | Lymphoma, Low-Grade | Leukemia, Lymphocytic, Acute | Leukemia, Lymphocytic, ChronicUnited States
-
Ontario Clinical Oncology Group (OCOG)Sunnybrook Health Sciences Centre; Genzyme, a Sanofi CompanyCompletedAlemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas (ACCAPELA)Peripheral T-cell LymphomasCanada
-
Chronic Lymphocytic Leukemia Research ConsortiumBayerUnknownB-Cell Chronic Lymphocytic LeukemiaUnited States
-
M.D. Anderson Cancer CenterTerminated
-
M.D. Anderson Cancer CenterBerlex Laboratories, Inc.CompletedChronic Lymphocytic LeukemiaUnited States
-
University of Wisconsin, MadisonWithdrawnNew Onset Type 1 Diabetes MellitusUnited States
-
Genzyme, a Sanofi CompanyCompletedLeukemia, Lymphocytic, Chronic, B-CellJapan
-
University of Wisconsin, MadisonTerminatedDisorder Related to Renal TransplantationUnited States