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


Phase 1
18 Years
80 Years
Not Enrolling
Both
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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)

Outcome Time Frame:

29 Days

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

MOZ00207

NCT ID:

NCT00694590

Start Date:

June 2008

Completion Date:

September 2011

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • AMD3100
  • Rituximab
  • Chronic Lymphocytic Leukemia
  • CLL
  • Small Lymphocytic Lymphoma
  • SLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

UTMD Anderson Cancer CenterHouston, Texas  77030
UCSD Moores Cancer CenterLa Jolla, California  93093
Ohio State University Comprehensive Cancer CenterColumbus, Ohio