Study of AMD3100 and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma - Full Text View

Sponsored by:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00694590

Purpose

The purpose of this research study is to determine if AMD3100 can release CLL/SLL cells into the blood and make them more sensitive to killing by rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study, AMD3100 will be added to standard treatment with rituximab. Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia.

The study is divided into Part 1 and Part 2. The purpose of Part 1 of the study is to find the highest dose of AMD3100 used with rituximab that can be given safely. The purpose of Part 2 of the study is to find out what effects (good and bad) that AMD3100, when used with rituximab, has on the subject and his/her leukemia.

Condition	Intervention	Phase
Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL)	Drug: Plerixafor	Phase I Phase II

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

Drug Information available for: Rituximab JM 3100

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of AMD3100 and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Further study details as provided by Genzyme:

Primary Outcome Measures:

Study Part 1: To determine the maximum tolerated dose of AMD3100 when used with rituximab for treatment for previously treated patients with CLL or SLL [ Time Frame: Ongoing over the course of Part 1 of the study ]
Study Part 2: To assess response to treatment using the 1996 NCIWG criteria for subjects with CLL and NCI IWG criteria for subjects with SLL [ Time Frame: 1 and 3 months following completion of study treatment ]

Secondary Outcome Measures:

Study Part 1: To determine the adverse effects and dose limiting adverse effects of AMD3100 when used with rituximab [ Time Frame: Ongoing over the course of Part 1 of the study ]
Study Part 2: subject survival without disease progression, subject survival, duration of responses to treatment [ Time Frame: Every 3 months for up to 2 years for patients who have at least stable disease ]
Study Parts 1 and 2: To determine the pharmacokinetics of AMD3100 when used with rituximab

Estimated Enrollment:	49
Study Start Date:	April 2008

Arms	Assigned Interventions
1: Experimental	Drug: Plerixafor

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent
Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period or be surgically sterile. Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during treatment and for 3 months after the treatment period or be surgically sterile
Diagnosis of CLL or SLL
CLL/SLL cells expressing CD20
Eastern Cooperative Oncology Group (ECOG) performance status of .2
Life expectancy of at least 12 weeks
Serum creatinine ≤2.0 mg/dL
Total bilirubin ≤2.0 mg/dL
ALT and AST ≤2 times the upper limit of normal (ULN); for patients with liver involvement of CLL/SLL disease, this limit is increased to ≤5 times the ULN
At the time of enrollment, patients must be >4 weeks since major surgery, radiotherapy, chemotherapy (>6 weeks for some chemotherapies), immunotherapy, biotherapy/targeted or investigational therapies

Exclusion Criteria:

WBC >50 x 109 cells/L
Subjects who have failed to respond to prior rituximab containing therapy
Women who are breastfeeding
Active viral hepatitis
Active infection or treatment with antimicrobial or antiviral therapy within 1 week of enrollment
History of prior allergic reaction to AMD3100 or rituximab
Significant lung disease
Serious cardiac disease within 6 months of enrollment or other significant medical or psychosocial conditions that warrant exclusion

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694590

Contacts

Contact: Medical Information	800-745-4447	medinfo@genzyme.com
Contact: Medical Information	617-252-7832	medinfo@genzyme.com

Locations

United States, Ohio
Ohio State University Comprehensive Cancer Center	Recruiting
Columbus, Ohio, United States
Contact: Thomas Lin, MD
Contact: John C Byrd, MD
Principal Investigator: Thomas Lin, MD
Sub-Investigator: John C Byrd, MD

Sponsors and Collaborators

Genzyme

More Information

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	MOZO00207
Study First Received:	June 6, 2008
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00694590
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

AMD3100
Rituximab
Chronic Lymphocytic Leukemia

CLL
Small Lymphocytic Lymphoma
SLL

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Rituximab

JM 3100
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell
Lymphoma

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Anti-HIV Agents
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs

Antiviral Agents
Pharmacologic Actions
Neoplasms
Anti-Retroviral Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009