Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT00290810 | Completed Phase 2 Results

• 9 other identifiers: NCI-2009-00137MAYO-MC048CNCI-7211CDR0000459933MC048C7211P30CA015083N01CM62205N01CM62207
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well bevacizumab works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer.

Conditions

B-cell Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).

  The NCI Working Group criteria will be used to assess response to therapy. A confirmed response is defined as a response documented on 2 consecutive evaluations at least 4 weeks apart. Complete Response: * No lymphadenopathy * No hepatomegaly or splenomegaly * Absense of constitutional symptoms * Polymorphonuclear leukocytes ≥ 1500/ul * Platelets \> 100,000/ul * Hemoglobin \> 11.0 gm/dl * Peripheral blood lymphocytes ≤ 4000/uL. * Confirmation by Marrow Aspirate and biopsy. Complete Clinical Response: -CR without bone marrow biopsy confirmation. Nodular Partial Response: -CR with the presence of residual clonal nodules. Partial Response requires: * ≥ 50% decrease in peripheral blood lymphocyte count * ≥ 50% reduction in lymphadenopathy * ≥ 50% reduction in size of liver and/or spleen * 1 or more of the following: * Polymorphonuclear leukocytes ≥ 1500/ul * Platelets \>100,000/ul * Hemoglobin \>11.0 gm/dl

  Up to 5 years

Secondary Outcomes (3)

• Toxicity Associated With This Regimen in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).

  From the date of registration to the to the date of last treatment evaluation, median number of days on treatment was 56 days.

• Overall Survival

  From the date of registration to the date of the event (i.e., death or the date of last follow-up), up to 5 years.

• Time to Progression

  From the date of registration to the date of the event (i.e., death or disease progression) or the date of last follow-up, up to 5 years

Study Arms (1)

Treatment (monoclonal antibody therapy)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: bevacizumab

Interventions

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Treatment (monoclonal antibody therapy)

Eligibility Criteria

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

You may qualify if:

• Diagnosis of B-cell chronic lymphocytic leukemia (CLL)\*, as defined by the following phenotypic characteristics:
• Predominant population of cells share both B-cell antigens (CD19, CD20, or CD23) as well as the T-cell antigen (CD-5), in the absence of other pan-T-cell markers (CD-3, CD-2, etc.)
• Mantle cell lymphoma must be excluded by demonstrating the absence of the t(11;14) by fluorescent in situ hybridization (FISH)
• Dim surface immunoglobulin expression
• Exclusively kappa and lambda light chains
• Peripheral blood absolute lymphocyte count \> 5,000/mm\^3
• Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
• Requires chemotherapy, as indicated by any of the following:
• Disease related symptoms, including the following:
• Weight loss ≥ 10% within the previous 6 months
• Extreme fatigue
• Fevers \> 100.5°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 anemia (hemoglobin ≤ 10 g/dL) and/or thrombocytopenia (platelet count ≤ 100,000/mm\^3)
• Massive (i.e., \> 6 cm below left costal margin) or progressive splenomegaly

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Tait Shanafelt, M.D.
• Organization: Mayo Clinic

shanafelt.tait@mayo.edu

Study Officials

• Tait Shanafelt

  Mayo Clinic

  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: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 13, 2006
• Study Start: December 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: August 1, 2010
• Last Updated: May 9, 2014
• Results First Posted: May 14, 2013

Record last verified: 2012-04

Locations

US (1)