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

NCT00280241 | Completed Phase 2 Results DMC

• 1 other identifier: 03-136
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic; Lymphocytic; Leukemia; Fludarabine; Cyclophosphamide; Rituximab

Outcome Measures

Primary Outcomes (2)

• Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL

  The number of patients who experience any grade 3-5 toxicity.

  Duration of treatment on study

• Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL

  The number of patients who experience a complete clinical response.

  Three months after the sixth cycle (9 months)

Secondary Outcomes (2)

• Overall Survival Rate

  Five years after starting rituximab, cyclophosphamide and fludarabine

• Duration of Response

  From complete response to the time of progressive disease, death or last clinical examination

Study Arms (1)

FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB

EXPERIMENTAL

Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Rituximab

Interventions

Fludarabine DRUG

Fludarabine is usually administered by IV infusion over 30 minutes or longer.

FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB

Cyclophosphamide DRUG

The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.

FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB

Rituximab DRUG

First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.

FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Genentech, Inc.: collaborator
• Biogen: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Bronchiolitis Obliterans Syndrome; Leukemia

Interventions

fludarabine; Cyclophosphamide; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Michael Boyiadzis, MD
• Organization: University of Pittsburgh

boyiadzism@upmc.edu

412-623-0040

Study Officials

• Micahel Boyiadzis, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: January 19, 2006
• First Posted: January 20, 2006
• Study Start: June 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: January 1, 2013
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-01

Locations

US (1)