Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia

Blastic Phase Chronic Myelogenous Leukemia Clinical Trial

Official title:

A Phase II Study of Bevacizumab (rhuMab VEGF, NSC 704865), Idarubicin and Cytarabine in Patients With Chronic Myeloid Leukemia in Blast Phase

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00023920
• Other study ID #: NCI-2012-02405
• Secondary ID: ID00-323N01CM170
• Status: Terminated
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: January 22, 2013
• Start date: July 2001

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This phase II trial is to see if combining bevacizumab with idarubicin and cytarabine works better in treating patients who have blast phase chronic myelogenous 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 deliver cancer-killing substances to them. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for blast phase chronic myelogenous leukemia

Description:

PRIMARY OBJECTIVES:

I. Determine the anti-leukemic activity of bevacizumab, idarubicin, and cytarabine in patients with blastic phase chronic myelogenous leukemia.

II. Determine the toxicity profile of this regimen in these patients. III. Determine the effect of bevacizumab on angiogenesis in these patients.

OUTLINE:

Patients receive bevacizumab IV over 90 minutes once on day -13. Patients then receive bevacizumab IV over 90 minutes and idarubicin IV on days 1 and 15 and cytarabine subcutaneously (SC) once daily beginning on day 1. Treatment repeats every 4 weeks for a maximum of 3 courses. Patients with responding disease receive maintenance therapy comprising bevacizumab IV over 90 minutes on days 1 and 15, idarubicin IV on day 1, and cytarabine SC once daily beginning on day 1. Treatment repeats every 4 weeks for 2 years in the absence of disease progression or unacceptable toxicity.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Philadelphia chromosome-positive blastic phase chronic myelogenous leukemia (CML), defined by 1 of the following:

• At least 30% blasts in peripheral blood and/or bone marrow

• Presence of extramedullary disease

• Performance status - Zubrod 0-2

• At least 8 weeks

• No prior coagulopathies

• Bilirubin no greater than 1.5 mg/dL

• INR less than 2

• PTT no greater than 60 seconds

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No nephrotic syndrome

• No uncontrolled hypertension

• No New York Heart Association class II-IV heart disease

• No prior thrombotic events

• LVEF = 50%

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No more than 2 prior chemotherapy regimens (no more than 1 regimen containing cytarabine) for CML in blast crisis

• Prior hydroxyurea allowed

• Prior imatinib mesylate allowed

• At least 10 days since prior anticoagulants

• No concurrent anticoagulants

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blast Crisis
• Blastic Phase Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Biological:
• bevacizumab
Given IV

Drug:
• idarubicin
Given IV
• cytarabine
Given SC

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in response rate		Up to 3 years	No
Primary	Controlled toxicity rate graded according to NCI Common Toxicity Criteria		Up to 3 years	Yes