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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

Inclusion Criteria


INCLUSION CRITERIA:

- Men or women ≥18 years of age

- Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any
detectable intensity

- Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy
or hepatosplenomegaly.

- Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease
within 1 year of a prior response

- ECOG performance status 0, 1, or 2

- Written informed consent

EXCLUSION CRITERIA:

- Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation,
immunotherapy, cytokine or biologic [with the exception of hematopoietic growth
factors]). Patients must have recovered from the adverse effects of prior therapy.

- Known primary or secondary malignancy of the central nervous system

- Any malignancy within the 5 years immediately prior to the first dose of study
medication with the exception of basal cell or non-metastatic squamous cell carcinoma
of the skin, and carcinoma in-situ of the cervix

- Serum creatinine >2.0mg/dL (>176 micromol/L)

- AST or ALT ≥3 x the upper limit of normal (ULN)

- Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert’s)

- Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)

- Known positivity for HIV

- Prior organ allograft

- Concurrent comorbid medical conditions that, in the opinion of the investigator,
preclude the safe delivery of the experimental treatment

- Pregnant or nursing women

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

Authority:

United States: Food and Drug Administration

Study ID:

PTH-203

NCT ID:

NCT00086203

Start Date:

Completion Date:

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Queens Medical Associates, PCFresh Meadows, New York  11365
Dana Farber Cancer InstituteBoston, Massachusetts  02115
NYU Medical CenterNew York, New York  10016
University of Arkansas for Medical ScienceLittle Rock, Arkansas  72205
Nevada Cancer InstituteLas Vegas, Nevada  89135
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Gulfcoast Oncology AssociatesSt. Petersburg, Florida  33705
Indiana Oncology/Hematology ConsultantsIndianapolis, Indiana  46202
Hematology/Oncology Centers of the Northern RockiesBillings, Montana  59101
James P. Wilmot Cancer Center/University of RochesterRochester, New York  14642
Raleigh Hematology/Oncology ClinicCary, North Carolina  27511
Cancer Care Associates/Oklahoma CityOklahoma City, Oklahoma  73112
Cancer Care Associates--TulsaTulsa, Oklahoma  74136
Texas Cancer Center/AbileneAbilene, Texas  79606-5208
Virginia Oncology Associates-Lake Wright Cancer CenterNorfolk, Virginia  23502