Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia - Full Text View

Sponsored by:	Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00462332

Purpose

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy.

PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.

Condition	Intervention	Phase
Leukemia	Drug: alemtuzumab Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: filgrastim Drug: fludarabine phosphate Drug: melphalan Drug: thiotepa Procedure: autologous hematopoietic stem cell transplantation Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cyclophosphamide Filgrastim Cytarabine Cytarabine hydrochloride Etoposide Carmustine Melphalan Thiotepa Fludarabine Fludarabine monophosphate Alemtuzumab Etoposide phosphate Melphalan hydrochloride Sarcolysin Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Antitumor activity [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]
Length of survival [ Designated as safety issue: No ]
Event-free survival [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	May 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic lymphocytic leukemia (CLL)
- Advanced or progressive disease with ≥ 2 active clinical signs

PATIENT CHARACTERISTICS:

Fertile patients must use adequate contraception
No positive Coomb's test with signs of hemolysis
No active infection
No uncontrolled severe disease
No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
No other malignancies within the past 2 years except for adequately treated malignancies
No significant traumatic injury within the past 4 weeks
No coexisting medical or psychological condition that would limit study compliance

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior treatment for CLL
No major surgery within the past 4 weeks
No prior chemotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462332

Show 51 Study Locations

Sponsors and Collaborators

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Study Chair:

Roberto Foa, MD

Universita Degli Studi "La Sapeinza"

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000540236, GIMEMA-LLC0405, EUDRACT-2005-00247-15, EU-20722
Study First Received:	April 18, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00462332
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Melphalan
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Carmustine
Cyclophosphamide
Fludarabine monophosphate
Etoposide phosphate
Thiotepa

Leukemia
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders
Etoposide
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009