Advertisement

Topics

Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia

2014-08-27 03:25:30 | BioPortfolio

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 block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with cyclophosphamide and rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.

Description

OBJECTIVES:

Primary

- Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia.

Secondary

- Determine the time to treatment failure (TTF) in these patients.

- Determine the overall survival of these patients at 10 years.

- Assess the predictive value of immunophenotype, hypermutation analysis, and FISH in determining TTF and OS in these patients.

- Determine the safety profile of this regimen.

OUTLINE: This is a multicenter study.

Patients receive fludarabine IV over 30 minutes or orally and cyclophosphamide IV or orally on days 1-3 and pegfilgrastim subcutaneously on day 4. Starting on course 2, patients receive rituximab IV on day 1. Treatment repeats every 28 days for up to 6* courses in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients achieving negative minimal residual disease receive 4 courses of treatment.

Blood samples are collected periodically for biomarker analysis. Samples are analyzed for protein expression (i.e., CD38, CD20, and ZAP70) by flow cytometry; quantitative immunoglobulins, β2-microglobulin, and T-cell subsets by electrophoresis; IgVH mutation status; and cytogenetics (i.e., +12, del 13q, del 11q, and del 17p) by FISH.

After completion of study therapy, patients are followed every 6 months for 5 years and then annually for 5 years.

Study Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia

Intervention

pegfilgrastim, rituximab, cyclophosphamide, fludarabine phosphate, cytogenetic analysis, fluorescence in situ hybridization, gene expression analysis, mutation analysis, protein expression analysis, flow cytometry, laboratory biomarker analysis

Location

St. James's Hospital
Dublin
England
Ireland
8

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:25:30-0400

Clinical Trials [2325 Associated Clinical Trials listed on BioPortfolio]

Fludarabine, Cyclophosphamide, and Rituximab Followed by Rituximab or Observation in Treating Older Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia

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 ...

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untre...

Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

Primary Objective: - To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline...

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

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 ...

Vorinostat, Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophospha...

PubMed Articles [16722 Associated PubMed Articles listed on BioPortfolio]

Outcomes of Second-Line Treatment After Fludarabine Cyclophosphamide and Rituximab in Patients with Chronic Lymphocytic Leukemia Outside Clinical Trials.

To evaluate disease characteristics and long-term outcomes in patients requiring second-line treatment following FCR, for relapsed/refractory disease (R/R), or following discontinuation due to toxicit...

Correction to: Fludarabine and rituximab with escalating doses of lenalidomide followed by lenalidomide/rituximab maintenance in previously untreated chronic lymphocytic leukaemia (CLL): the REVLIRIT CLL-5 AGMT phase I/II study.

The original version of this article contained a mistake. The name of Tanja Nicole Hartman should have been Tanja Nicole Hartmann. The original article has been corrected.

Effectiveness and Safety of Pegfilgrastim in BEP Treatment for Patients with Germ Cell Tumor.

The effectiveness and safety of pegfilgrastim during bleomycin, etoposide and cisplatin (BEP) chemotherapy have not yet been investigated.

Phase 2 trial of bortezomib in combination with rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with bortezomib, rituximab, methotrexate, and cytarabine for untreated mantle cell lymphoma.

Although the outcomes of patients with mantle cell lymphoma (MCL) have improved, there is still no cure. Bortezomib has a 33% response rate in relapsed/refractory MCL and has shown additive and/or syn...

Intravenous cyclophosphamide vs rituximab for the treatment of early diffuse scleroderma lung disease: open label, randomized, controlled trial.

SSc is characterized by fibrotic changes in the skin and lung, and the mainstay of treatment has been CYC. B cell involvement suggests that rituximab (RTX) may also be of therapeutic benefit. The aim ...

Medical and Biotech [MESH] Definitions

MOLECULAR BIOLOGY techniques used in the diagnosis of disease. Included are such techniques as IN SITU HYBRIDIZATION of chromosomes for CYTOGENETIC ANALYSIS; OLIGONUCLEOTIDE ARRAY SEQUENCE ANALYSIS of gene expression patterns in disease states; identification of pathogenic organisms by analysis of species specific DNA sequences; and detection of mutations with POLYMERASE CHAIN REACTION.

Determination of the nature of a pathological condition or disease in the ovum, zygote, or blastocyst prior to implantation. CYTOGENETIC ANALYSIS is performed to determine the presence or absence of genetic disease.

A scanning microscope-based, cytofluorimetry technique for making fluorescence measurements and topographic analysis on individual cells. Lasers are used to excite fluorochromes in labeled cellular specimens. Fluorescence is detected in multiple discrete wavelengths and the locational data is processed to quantitatively assess APOPTOSIS; PLOIDIES; cell proliferation; GENE EXPRESSION; PROTEIN TRANSPORT; and other cellular processes.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

Measurement of the intensity and quality of fluorescence.

More From BioPortfolio on "Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers)  - Mouth cancer can develop on the lip, the tongue, the floor...


Searches Linking to this Trial