Alemtuzumab/Fludarabine for Relapsed/Refractory B-CLL - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00206726

Purpose

This is a multi-center, Phase II, open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-CLL patients who have received at least one prior therapy.

Condition	Intervention	Phase
Leukemia, Lymphocytic, Chronic, B-Cell	Drug: Alemtuzumab and Fludarabine Phosphate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Resource links provided by NLM:

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

Drug Information available for: Fludarabine Fludarabine monophosphate Campath Alemtuzumab

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Complete Response [ Time Frame: 28 days after last cycle ]

Secondary Outcome Measures:

Overall response rate [ Time Frame: 28 days after last cycle ]
Survival at 1 year [ Time Frame: 1 year ]
Time to progression [ Time Frame: Progression ]
Duration of response [ Time Frame: Relapse ]
Adverse event profile [ Time Frame: 28 days after last cycle ]
Minimal residual disease [ Time Frame: CR ]
Lymphocyte and lymphocyte subset recovery

Estimated Enrollment:	60
Study Start Date:	May 2005

Detailed Description:

Number of arms: 1

(Treatments will be administered on a 28-day cycle for 4-6 cycles, with an evaluation during Cycle 4 to permit re-staging. Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle. Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6. At the time of the re-staging, patients achieving a Partial Remission (PR) or Stable Disease (SD) will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission (CR) will receive no further treatment but will be followed for response)

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patient must have confirmed B-CLL.
Patients must have received at least one prior therapy and must require treatment for active disease

Exclusion Criteria:

Treatment with any anti-cancer agents within 4 weeks of start of study.
History of significant allergic reaction to antibody therapies
History of HIV positivity.
Active infection requiring treatment
Pregnancy or lactation
Other severe, concurrent diseases or mental disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206726

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Berlex, Inc. Medical Affairs

1-888-BERLEX4

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	305825, ECO-1
Study First Received:	September 19, 2005
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00206726 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Leukemia, Lymphoid
Immunoproliferative Disorders
Immunologic Factors
Fludarabine monophosphate
Immunosuppressive Agents
Leukemia
Lymphatic Diseases

Chronic Lymphocytic Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders
Leukemia, B-cell, Chronic

Additional relevant MeSH terms:

Antimetabolites
Leukemia, Lymphoid
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Fludarabine monophosphate

Immunosuppressive Agents
Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Alemtuzumab
Fludarabine
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 11, 2009