NCT00254163

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

November 3, 2016

Completed
Last Updated

November 3, 2016

Status Verified

September 1, 2016

Enrollment Period

7.8 years

First QC Date

November 9, 2005

Results QC Date

February 2, 2016

Last Update Submit

September 15, 2016

Conditions

B-Cell Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Infection Rate

    infection=febrile events requiring treatment

    6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

Secondary Outcomes (8)

  • Infective Event Rate

    6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

  • Percentage of Patients Hospitalized

    6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

  • Hematologic Recovery

    2 months post-treatment

  • Mean Absolute Neutrophil Count (ANC) at Post-treatment

    2 months post-treatment

  • Complete Remission (CR)

    6 cycles of 28-day for FCR and 8 cycles of 21-day for PCR, or until PD, CR, or intolerable toxicity

  • +3 more secondary outcomes

Study Arms (2)

Fludarabine, Cyclophosphamide, and Rituximab

ACTIVE COMPARATOR

Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle)

Drug: FludarabineDrug: CyclophosphamideDrug: Rituximab

Pentostatin, Cyclophosphamide, and Rituximab

EXPERIMENTAL

Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)

Drug: CyclophosphamideDrug: RituximabDrug: Pentostatin

Interventions

FludarabineDRUG
Fludarabine, Cyclophosphamide, and Rituximab
CyclophosphamideDRUG
Fludarabine, Cyclophosphamide, and RituximabPentostatin, Cyclophosphamide, and Rituximab
RituximabDRUG
Fludarabine, Cyclophosphamide, and RituximabPentostatin, Cyclophosphamide, and Rituximab
PentostatinDRUG
Also known as: Nipent
Pentostatin, Cyclophosphamide, and Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • +3 more criteria

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cancer Centers of Florida, P.A.

Ocoee, Florida, 34761, United States

Location

Hope Center

Terre Haute, Indiana, 47802, United States

Location

Alliance Hematology Oncology PA

Westminster, Maryland, 21157, United States

Location

St Joseph Oncology, Inc

Saint Joseph, Missouri, 64507, United States

Location

New York Oncology Hematology, PC

Albany, New York, 12208, United States

Location

Northwestern Carolina Oncology Hemato

Hickory, North Carolina, 28602, United States

Location

Medical Oncology Associates

Kingston, Pennsylvania, 18704, United States

Location

South Texas Cancer Center-McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology Cancer Center-Sugar Land

Sugar Land, Texas, 77479, United States

Location

Cancer Care Northwest-South

Spokane, Washington, 99202, United States

Location

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabineCyclophosphamideRituximabPentostatin

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoformycinFormycinsPyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Dr. Craig Reynolds
Organization
Ocala Oncology
Craig.Reynolds@USOncology.com
(352) 732-4032

Study Officials

  • Craig Reynolds, MD

    US Oncology Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 15, 2005

Study Start

December 1, 2003

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

November 3, 2016

Results First Posted

November 3, 2016

Record last verified: 2016-09

Locations

US(11)