Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase

NCT00003694 | Completed Phase 2

• 3 other identifiers: NCI-2012-02786CALGB-19804U10CA031946
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

Conditions

Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

• Complete cytogenetic, major cytogenetic, and hematologic response rate

  Two separate single-stage Fleming designs will be used to test hypotheses regarding the major cytogenetic response rate and the complete cytogenetic response rate. Calculated and presented with their 95% confidence intervals.

  Up to 9 months

Secondary Outcomes (3)

• Toxicity rates as assessed by Common Terminology Criterial version 2.0

  Up to 9 months

• Duration of hematological response

  Up to 10 years

• Time to hematological progression

  Up to 10 years

Study Arms (1)

Treatment (omacetaxine mepesuccinate, cytarabine)

EXPERIMENTAL

Patients receive cytarabine and homoharringtonine concurrently by continuous intravenous infusion for 7 days. Courses repeat every 28 days. Patients receive a minimum of 9 courses of therapy in the absence of disease progression and unacceptable toxicity. Patients who are major cytogenetic responders at 9 months may continue therapy or switch to interferon. Minor cytogenetic responders are switched to interferon, and nonresponders are removed from therapy and given the option to switch to interferon.

Drug: omacetaxine mepesuccinate; Drug: cytarabine; Other: laboratory biomarker analysis

Interventions

omacetaxine mepesuccinate DRUG

Given IV

Also known as: CGX-635, homoharringtonine

Treatment (omacetaxine mepesuccinate, cytarabine)

cytarabine DRUG

Given IV

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside

Treatment (omacetaxine mepesuccinate, cytarabine)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (omacetaxine mepesuccinate, cytarabine)

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:

• Histologic diagnosis of chronic myelogenous leukemia (CML) in chronic phase; patients in either accelerated or blastic phases are not eligible; clonal cytogenetic evolution alone does not exclude patients
• Patients must meet one or more of the following criteria:
• Cytogenetically determined Philadelphia chromosome (Ph+)
• BCR/ABL protein detectable by immunoblotting
• Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL
• BCR/ABL translocation present by fluorescence in situ hybridization (FISH)
• Registration within eight weeks of the diagnosis and confirmation of Ph+ or BCR/ABL+ CML
• No more than eight weeks of prior hydroxyurea therapy
• No previous therapy with homoharringtonine (HHT)
• No prior treatment for CML with agents other than hydroxyurea; thus, prior treatment for CML with agents such as interferon, busulfan or cytarabine will render patients ineligible
• Must not be a candidate for an early allogeneic bone marrow transplant; potential transplant candidates must be counseled about alternative donor transplants and must decline that treatment option
• ECOG performance status 0-2
• Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
• Bilirubin =\< x upper limit of normal
• Creatinine =\< 1.5 mg/dl

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Dana-Farber Harvard Cancer Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

Interventions

Homoharringtonine; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Richard Stone

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

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: November 1, 1999
• First Posted: December 5, 2003
• Study Start: March 1, 1999
• Primary Completion: August 1, 2003
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)