Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Prolymphocytic Leukemia

NCT00281931 | Terminated Phase 2

• 2 other identifiers: PLL1EU-20563
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving fludarabine and cyclophosphamide together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with rituximab works in treating patients with B-cell prolymphocytic leukemia.

Conditions

Prolymphocytic Leukemia

Keywords

prolymphocytic leukemia

Outcome Measures

Primary Outcomes (3)

• Overall survival

• Progression-free survival

• Toxicity

Interventions

rituximab BIOLOGICAL

cyclophosphamide DRUG

fludarabine phosphate DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of B-cell prolymphocytic leukemia * Previously treated disease * All Binet stages allowed PATIENT CHARACTERISTICS: * Life expectancy \> 3 months * ECOG/WHO performance status 0-3 PRIOR CONCURRENT THERAPY: * No more than 3 prior treatment regimens

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German CLL Study Group: lead

Study Sites (1)

Helios Klinikum Erfurt

Erfurt, 99012, Germany

Location

MeSH Terms

Conditions

Leukemia, Prolymphocytic

Interventions

Rituximab; Cyclophosphamide; fludarabine phosphate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael Herold, MD, PhD

  HELIOS Hospital, Erfurt, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: September 1, 1999
• Primary Completion: April 1, 2006
• Study Completion: October 1, 2006
• Last Updated: September 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)