Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

This study has been completed.
Sponsor:
Collaborator:
Astex Pharmaceuticals
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00254163
First received: November 9, 2005
Last updated: May 19, 2014
Last verified: May 2014

November 9, 2005
May 19, 2014
December 2003
September 2011   (final data collection date for primary outcome measure)
Infection Rate [ Time Frame: 6 28-day cycles or 8 21-day cycles (depending on arm) or until PD, CR, or intolerable toxicity ] [ Designated as safety issue: Yes ]
Febrile events requiring treatment. Febrile events are any temperature >= 101 F.; treatment is defined as the administration of IV or oral antibiotic therapy.
Not Provided
Complete list of historical versions of study NCT00254163 on ClinicalTrials.gov Archive Site
Mean Absolute Neutrophil Count [ Time Frame: 2 months following last dose for both arms ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients
A Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-cell Chronic Lymphocytic Leukemia

The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
B-Cell Chronic Lymphocytic Leukemia
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Drug: Rituximab
  • Drug: Pentostatin
    Other Name: Nipent
  • Active Comparator: Fludarabine, Cyclophosphamide, and Rituximab
    Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle)
    Interventions:
    • Drug: Fludarabine
    • Drug: Cyclophosphamide
    • Drug: Rituximab
  • Experimental: Pentostatin, Cyclophosphamide, and Rituximab
    Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Rituximab
    • Drug: Pentostatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
September 2011
September 2011   (final data collection date for primary outcome measure)

INCLUSION CRITERIA:

Patients will be eligible for inclusion in this study if they meet all of the following criteria:

  • Progressive, histologically proven B-cell CLL.
  • Stage II, III, or IV B-cell CLL, as defined by Appendix III.

Note: The pathology or flow cytometry (of peripheral blood or a bone marrow) report, done by the local laboratory which documents these findings, must be included in the source documents. The SI must review the above pathology report or flow cytometry report results (including bone marrow aspirate analysis and CD5 and CD20 results) by fax, prior to registration, to confirm each patient's eligibility. Results should be consistent with typical B-cell CLL. If Dr. Reynolds is not available to review these documents, they must be reviewed by Dr. Nicholas J. Di Bella.

  • Patient must be CD20 +
  • Patient must be CD5+ (CD5 >70%)
  • No more than 1 prior course (regimen) of chemotherapy, which can include Fludara or Rituxan
  • No prior radiation therapy, except for the treatment of skin cancer or a nonmalignant condition.
  • If patient has lymph node involvement, a CT scan confirming measurable tumor size (lymph node must be >1 cm in its longest transverse diameter).
  • SI has been notified IF patient is on replacement steroids at time of registration.
  • Age greater than 18 years.
  • ECOG performance status of 0-2 (Appendix I).
  • Normal renal function (creatinine <1.5 mg/dL and BUN <25 mg/dL).
  • Absolute neutrophil count (ANC) greater than 1,000 cells/µL, platelet count greater than 50,000 cells/µL, and hemoglobin greater than 9 g/dL.
  • Bilirubin less than 2.0 mg/dL, and AST and ALT less than 5 times the upper limit of normal.
  • Negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential).
  • Agrees to use an acceptable method of birth control, if fertile patient (male or female), to avoid pregnancy for the duration of the study and for at least 3 months thereafter.
  • A signed Patient Informed Consent Form has been obtained.
  • A signed Patient Authorization Form has been obtained.

EXCLUSION CRITERIA:

Patients will be excluded from this study if they meet any of the following criteria:

  • Any disease other than histologically confirmed progressive, Stage II, III, or IV CLL.
  • Well differentiated lymphocytic lymphoma in nodes without lymphocytosis.
  • More than 1 prior course (regimen) of chemotherapy.
  • Any radiation for the treatment of CLL.
  • Any prior Nipent.
  • Known to be CD20 negative (CD20 <20%).
  • Pregnant or lactating, or has a positive pregnancy test.
  • Has a history of other malignancy (other than in situ cervical cancer, carcinoma intraepithelial neoplasia, or non-melanoma skin cancer) within the last 5 years, which could affect the administration of these study drugs or assessment of current CLL.
  • Known to be HIV positive.
  • Uncontrolled thyroid disease or uncontrolled abnormal thyroid function.

Note: Patients with thyroid disease that is controlled with medication may participate.

  • A history of recent, unstable organic heart disease or stable organic heart disease with LVEF <50%.
  • A known hypersensitivity to Fludara, Nipent, Rituxan, or Cytoxan, or any component of these drugs.
  • Autoimmune hemolytic anemia.
  • Unable to comply with requirements of study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00254163
03017, NIP-03-007
No
US Oncology Research
US Oncology Research
Astex Pharmaceuticals
Principal Investigator: Craig Reynolds, MD US Oncology Research
US Oncology Research
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP