FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)

NCT00448019 | Completed Phase 2 Results

• 2 other identifiers: MDACC-2005-0992NCI-2010-00591
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if the combination of fludarabine, cyclophosphamide, rituximab, and bevacizumab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy. The safety of this treatment will also be studied.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; Fludarabine; Cyclophosphamide; Rituximab; Bevacizumab; CLL

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Rate

  Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  Baseline up to 5 years

Secondary Outcomes (2)

• Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)

  Response assessed after three 4-week courses and after six courses, up to 24 weeks

• Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL

  Response assessed after three 4-week courses and after six courses, up to 24 weeks

Study Arms (1)

FCR + Bevacizumab

EXPERIMENTAL

FCR = Fludarabine 25 mg/m\^2 intravenous (IV) , Cyclophosphamide 250 mg/m\^2 IV daily for 3 days, Rituximab 375 mg/m\^2 IV Day 1, followed by 500 mg/m\^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.

Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Rituximab; Drug: Bevacizumab

Interventions

Fludarabine DRUG

25 mg/m\^2 IV over 30 minutes daily for 3 days

Also known as: Fludara, Fludarabine Phosphate

FCR + Bevacizumab

Cyclophosphamide DRUG

250 mg/m\^2 IV over 30 minutes daily for 3 days

Also known as: Cytoxan, Neosar

FCR + Bevacizumab

Rituximab DRUG

375 mg/m\^2 IV on Day 1 by prolonged infusion. All subsequent doses 500 mg/m\^2 IV 30-minute infusion.

Also known as: Rituxan

FCR + Bevacizumab

Bevacizumab DRUG

10 mg/Kg IV on Day 3, course 1 over 30-90 minutes

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

FCR + Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Diagnosis of B-cell CLL
• Relapsed, fludarabine-sensitive (duration of response \> 6 months as assessed by prior treating physician) or fludarabine-naive patients
• Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling of peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms.
• Prestudy WHO Performance Status \</= 2.
• Signed, written Institutional Review Board (IRB)approved informed consent.
• Men and women of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment.
• Acceptable liver function: Bilirubin \</= 2.0 mg/dL (26 umol/L), AST (SGOT) and/or ALT (SGPT) \</= 2 times upper limit of normal.
• Acceptable hematologic status: Platelet count \>/= 50 x 10\^9/L., absolute neutrophil count (ANC) \>/= 1 x 10\^9/L.
• Acceptable renal function: Serum creatinine \</= 2.0 mg/dL

You may not qualify if:

• Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1.
• Known infection with HIV, hepatitis B, or hepatitis C
• Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia \[PLL\]).
• Patients with secondary malignancy requiring active treatment (except hormonal therapy).
• Active uncontrolled bacterial, viral, or fungal infections.
• New York Heart Association Class II-IV cardiac disease or myocardial infarction within the past 6 months prior to Study Day 1.
• Pregnant or currently breast-feeding.
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
• Blood pressure of \> 150/100 mmHg
• Unstable angina
• History of stroke within 6 months
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 1.

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 Publications (1)

• Jain P, Lee HJ, Qiao W, Wierda W, Benjamini O, Burger J, Ferrajoli A, Estrov Z, Kantarjian H, Keating M, O'Brien S. FCR and bevacizumab treatment in patients with relapsed chronic lymphocytic leukemia. Cancer. 2014 Nov 15;120(22):3494-501. doi: 10.1002/cncr.28910. Epub 2014 Jul 15.

  PMID: 25043749 RESULT

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabine; fludarabine phosphate; Cyclophosphamide; Rituximab; Bevacizumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; 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; Antibodies, Monoclonal, Humanized

Results Point of Contact

• Title: MD Anderson Cancer Center Leukemia Department
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Susan O'Brien, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: 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: March 13, 2007
• First Posted: March 15, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 2, 2015
• Results First Posted: November 2, 2015

Record last verified: 2015-10

Locations

US (1)