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Sponsored by: |
German CLL Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00634881 |
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Leukemia |
Biological: alemtuzumab Genetic: polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis Other: pharmacological study |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Consolidation Therapy With Alemtuzumab (MabCampath®) in Patients With Chronic Lymphocytic Leukemia Who Are in Complete or Partial 2nd Remission After Cytoreduction With Fludarabine or Fludarabine Plus Cyclophosphamide or Fludarabine Plus Cyclophosphamide Plus Rituximab or Bendamustine or Bendamustine Plus Rituximab - a Phase I/II Study |
Estimated Enrollment: | 36 |
Study Start Date: | November 2003 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of alemtuzumab.
After completion of study treatment, patients are followed at 3, 6, 9, 12, 18, and 24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Disease in complete or partial remission after completion of 4-6 courses of second-line cytoreductive therapy no less than 90 days and no more than 150 days ago
Second-line cytoreductive therapy must comprise 1 of the following regimens:
Complete minimal residual disease response defined by the following:
At least negativity of 4-color-cytometry and/or even PCR-amplifiable clonal CDR III rearrangement of the IgV_H
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Severe infection during second-line treatment with F/FC/FCR/B/BR, meeting any 1 of the following criteria:
Concurrent severe diseases that exclude the administration of protocol therapy, including any of the following:
PRIOR CONCURRENT THERAPY:
Germany | |
III Medizinische Klinik Mannheim | Recruiting |
Mannheim, Germany, D-68305 | |
Contact: Contact Person 49-621-383-4152 nicolai.haertel@med3.ma.uni-heidelberg.de | |
Klinikum Barnim GmbH, Werner Forssmann Krankenhaus | Recruiting |
Eberswalde, Germany, 16225 | |
Contact: Contact Person 49-89-595-191 abenhardt@t-online.de | |
Klinikum Lippe - Lemgo | Recruiting |
Lemgo, Germany, D-32657 | |
Contact: Contact Person 49-526-126-4129 karin.heinisch@klinikum-lippe.de | |
Universitatsklinikum Heidelberg | Recruiting |
Heidelberg, Germany, D-69115 | |
Contact: Contact Person 49-622-156-8023 manfred.hensel@med.uni-heidelberg.de | |
Medizinische Universitaetsklinik I at the University of Cologne | Recruiting |
Cologne, Germany, D-50924 | |
Contact: Michael Hallek, MD 49-221-478-4400 | |
Krankenhaus Barmherzige Brueder Regensburg | Recruiting |
Regensburg, Germany, D-93049 | |
Contact: Contact Person 49-941-264-129 |
Study Chair: | Michael Hallek, MD | Medizinische Universitaetsklinik I at the University of Cologne |
Study ID Numbers: | CDR0000587746, GCLLSG-CLL2I, BAYER-GCLLSG-CLL2I, EU-20816 |
Study First Received: | March 12, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00634881 History of Changes |
Health Authority: | Unspecified |
infection B-cell chronic lymphocytic leukemia stage III chronic lymphocytic leukemia |
stage IV chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia |
Leukemia, Lymphoid Immunoproliferative Disorders Rituximab Cyclophosphamide Fludarabine monophosphate Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia |
Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Fludarabine Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Bendamustine |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Pharmacologic Actions Leukemia |
Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Therapeutic Uses Leukemia, B-Cell Lymphoproliferative Disorders |