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Study of AMD3100 (Plerixafor) and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)

Intervention: plerixafor (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study, plerixafor 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 primary objective is to determine the maximum tolerated dose (MTD) of plerixafor when combined with rituximab as treatment for previously treated patients with CLL or SLL.

Clinical Details

Official title: Phase I Study of AMD3100 and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The maximum tolerated dose of plerixafor when combined with rituximab as treatment for previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Secondary outcome:

The principal toxicities and dose limiting toxicities of plerixafor when combined with rituximab

Time to maximal plasma concentration (Tmax) when plerixafor is combined with rituximab

Area under the concentration-time curve from time zero to the last observed concentration (AUC 0-last) when plerixafor is combined with rituximab

Area under the concentration-time curve over the dosing interval (τ) (AUC 0-τ) when plerixafor is combined with rituximab

Area under the concentration-time curve from time zero to infinity (AUC 0-∞ ) when plerixafor is combined with rituximab

Half-life (T½) when plerixafor is combined with rituximab

Volume of distribution (Vz/F for subcutaneous (SC) administration; Vz for intravenous (IV) administration);

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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, relapsed from at least one prior therapy.

- CLL/SLL cells expressing CD20 documented during screening.

- 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 (alanine aminotransferase) and AST (aspartate aminotransaminase) ≤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 and recovered from the toxicity of prior treatment to ≤ grade 1. Exclusion Criteria:

- White Blood Cells (WBC) >250 x 10^9 cells/L.

- Disease refractory to rituximab therapy- defined as a failure to respond to prior

rituximab-containing regimen.

- Women who are breastfeeding.

- Active viral hepatitis.

- Active infection or treatment with antimicrobial or antiviral therapy within 1 week

of enrollment with the exception of prophylactic therapy.

- History of prior allergic reaction to plerixafor or rituximab.

- Significant lung disease.

- Serious cardiac disease such as a history of sustained ventricular arrhythmia,

uncontrolled and serious congestive heart failure (CHF), angina, acute coronary syndrome, or myocardial infarction within 6 months of enrollment or other significant medical or psychosocial conditions that warrants exclusion.

Locations and Contacts

UCSD Moores Cancer Center, La Jolla, California, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

UTMD Anderson Cancer Center, Houston, Texas, United States

Additional Information

Starting date: June 2008
Last updated: March 19, 2015

Page last updated: August 23, 2015

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