Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

NCT00794820 | Completed Phase 2 Results

• 2 other identifiers: 2003-0591NCI-2010-01220
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. Secondary Objective:
• To evaluate remission duration and survival.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; CLL; Leukemia; Fludarabine phosphate; Cyclophosphamide; Rituximab; FCR; Cytoxan®; Neosar®; Rituxan®

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months

  CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to \> 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD.

  6 months

Secondary Outcomes (2)

• Remission Duration/Time to Progression (TTP)

  6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.

• Overall Survival (OS) Rate

  6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.

Study Arms (1)

FCR-Multiple Dose Rituximab

EXPERIMENTAL

Fludarabine phosphate + Cyclophosphamide + Rituximab

Drug: Fludarabine Phosphate; Drug: Cyclophosphamide; Drug: Rituximab

Interventions

Fludarabine Phosphate DRUG

25 mg/m\^2 by vein over 5-30 minutes daily for 3 days (days 2-4)

Also known as: Fludara®, Fludarabine

FCR-Multiple Dose Rituximab

Cyclophosphamide DRUG

250 mg/m\^2 by vein over 60 minutes daily for 3 days (days 2-4)

Also known as: Cytoxan®, Neosar®

FCR-Multiple Dose Rituximab

Rituximab DRUG

375 mg/m\^2 by vein for dose 1 (given 1 day prior to chemotherapy) and then 500 mg/m\^2 on days 2-3

Also known as: Rituxan®

FCR-Multiple Dose Rituximab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Untreated CLL with indication for therapy or minimally treated (e.g. less than 1 month of steroids or chemotherapy) are eligible
• Performance status of 3 or better (Appendix A)
• Adequate renal and hepatic function (creatinine \<2 mg%, bilirubin \<2mg%). Patient with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman but upper limits for creatinine even under these circumstances would be creatinine \< 3 mg% and bilirubin \< 6 mg%. Patients with Gilbert's Syndrome may be entered on study with bilirubin 2-7 mg%..
• A signed informed consent in keeping with policies of the hospital

You may not qualify if:

• \) None

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

fludarabine phosphate; 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

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: Susan O'Brien, MD/ Leukemia
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

1-877-632-6789

Study Officials

• Susan O'Brien, M.D.

  M.D. Anderson Cancer 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: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 20, 2008
• Study Start: December 1, 2003
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 8, 2018
• Results First Posted: August 23, 2016

Record last verified: 2018-04

Locations

US (1)