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CompletedPhase 2NCT00280241
Official study title

Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia

Study summary

This research study will look at the effects (good or bad) of administering cyclophosphamide, fludarabine, and rituximab. Clinical studies with combination therapy have shown higher response rates than using single drugs, and this study will evaluate the side effects and effectiveness of this combination.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedFludarabine and Cyclophosphamide

Plus 1 other study approaches.

Who it may be forChronic Lymphocytic Leukemia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 4, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Pittsburgh

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Pittsburgh
Interventions being studied
Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Rituximab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Diagnosis of CD20 + CLL
  • Peripheral blood absolute lymphocyte count of \> 5,000/mm3 obtained within 2 weeks prior to randomization.
  • The lymphocytosis must consist of small to moderate size lymphocytes, with ≤55% (no greater than 55%) prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically.
  • Phenotypically characterized CD20 + CLL defined as: 1) the predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-celI markers (CD3, CD2, etc.); 2) B-cell expresses either kappa or lambda light chains; and 3) surface immunoglobulin (slg) with low-cell surface density expression.
  • Splenomegaly, hepatomegaly or lymphadenopathy are not required for the diagnosis of CLL.
  • Must require chemotherapy. Indications for chemotherapy are one or more of the following:
  • One or more of the following disease-related symptoms
  • Weight loss \>10% within the previous 6 months.
  • Fevers of greater than 100.0° F for 2 weeks without evidence of infection.
  • Night sweats without evidence of infection.
  • Evidence of progressive marrow failure as manifested by the development of or worsening of anemia (\< 10 g/dl) and/or thrombocytopenia (\< 100,000/mm3).
  • Massive (i.e., \> 6 cm below left costal margin) or progressive splenomegaly.
  • Massive nodes or clusters (i.e., \> 10 cm in longest diameter) or progressive
  • adenopathy.
  • Progressive lymphocytosis with an increase of\> 50% over 2 month period, or an anticipated doubling time of less than 6 months.
  • NOTE: Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease are not sufficient for protocol therapy.
  • Serum creatinine \<1.5 mg/dl.
  • Bilirubin must be \<2 mg/dl, unless secondary to tumor, obtained within 2 weeks prior to randomization.
  • Age \>18 years.
  • Not pregnant (confirmed by serum pregnancy test in females of reproductive potential) or breast feeding, because it is unknown what effect these drugs will have on children.
  • ECOG performance status 0-2.
  • AST or ATL \>2x upper limit of normal unless related to CLL.
  • Subject has provided written informed consent.
Reasons someone may not be able to joinExclusion criteria
  • Subjects with autoimmune anemia or thrombocytopenia are not eligible.
  • No prior cytotoxic chemotherapy. Patients with a history of steroid treatment for CLL, autoimmune hemolytic anemia, or autoimmune thrombocytopenia are not eligible.
  • Subjects with active infections requiring oral or intravenous antibiotics until resolution of the infection and completion of therapeutic antibiotics.
  • Women of childbearing potential and sexually active males who refuse to use an accepted and effective method of contraception.
  • Subjects with a second malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible unless the tumor was treated with curative intent at least two years previously.
  • History of HIV
  • CNS disease
  • History of psychiatric disorder that would make it difficult to enroll and follow the patient on trial.
  • New York Heart Classification III or IV heart disease.
  • Hepatitis BsAg or Hepatitis C positive.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Hillman Cancer CenterPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 4, 2016. Always confirm current availability with the study team.

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