Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Rituximab

Pentostatin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Adenosine

Enzyme Inhibitors

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

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

Craig Reynolds, MD

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.

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

infection=febrile events requiring treatment

infective events=temperature \>101 without symptoms or temp \<101 with symptoms

Percentage of patients who were hospitalized due to any reasons during the study period.

defined as Hb \>11g/dL and a platelet count \>100 × 10\^3/mm\^3

mean Absolute Neutrophil Count (ANC) measured 2 months (8-10 weeks) following the last dose of study treatment

Definitions of response is evaluated using guidelines proposed by the National Cancer Institute-Sponsored Working Group for Chronic Lymphocytic Leukemia.

Complete remission (CR) requires all of the following for a period of at least 2 months:

1. Absence of lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must be \<1 cm.
2. No evidence of hepatomegaly or splenomegaly.
3. Absence of constitutional symptoms.
4. Normal CBC as exhibited by:

   * Polymorphonuclear leukocytes ≥ 1,500/mm\^3
   * Platelets \> 100,000/mm\^3
   * Hemoglobin \> 11.0 g/dL (untransfused)
5. Bone marrow aspirate and biopsy should be performed 2 months after clinical and laboratory results demonstrate that all of the requirements listed in 1-4 have been met to demonstrate that a CR has been achieved. The marrow sample must be at least normocellular for age, with less than 30% of the nucleated cells being lymphocytes.

Lymphoid nodules should be absent.

Complete remission (CR) see Outcome Measure 6. Partial remission (PR) must exhibit criteria 1 and 2 as well as one or more of the remaining features for at least 2 months.

1. ≥50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value.
2. ≥50% reduction in lymphadenopathy.
3. ≥50% reduction in the size of the liver and/or spleen.
4. Polymorphonuclear leukocytes ≥ 1,500/mm\^3 or 50% improvement over baseline.
5. Platelets \>100,000/mm\^3 or 50% improvement over baseline.
6. Hemoglobin \>11.0 g/dL or 50% improvement over baseline without transfusions. Nodular partial remission (nPR) is defined as a CR with persistent bone marrow nodules; Objective Remission (OR) = CR + PR + nPR.

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

Astex Pharmaceuticals, Inc.

US Oncology Research

The safety population, which received at least one of study treatment, was included in the analysis of adverse event. Patients included in this study were 88 and 89 in FCR arm and PCR arm, respectively.

Spots Global Cancer Trial Database for Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

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Study Description

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