Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00003694 |
|
Recruitment Status :
Completed
First Posted : December 5, 2003
Last Update Posted : June 5, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Phase Chronic Myelogenous Leukemia | Drug: omacetaxine mepesuccinate Drug: cytarabine Other: laboratory biomarker analysis | Phase 2 |
PRIMARY OBJECTIVES:
I. To estimate the hematologic and cytogenetic response rate of newly diagnosed patients with BCR/ABL (+) chronic myelogenous leukemia (CML) treated with combined homoharringtonine (omacetaxine mepesuccinate) and low dose cytarabine.
II. To estimate the toxicity of these two drugs given in combination in a cooperative group setting.
SECONDARY OBJECTIVES:
I. To assess duration of hematological response and incidence of hematological progression for all patients.
II. To assess duration of cytogenetic response in patients continuing protocol therapy beyond the initial nine months.
III. To use quantitative Southern blot monitoring of blood samples to monitor molecular response rates in patients entered onto CALGB treatment studies for CML.
IV. To compare quantitative Southern blot results of blood samples with marrow cytogenetics at the time of complete molecular response.
V. To use RT-PCR to monitor the frequency of residual disease in patients who have achieved a complete blood Southern blot and marrow cytogenetic response (elimination of BCR/ABL positivity by Southern blot and absence of the Philadelphia chromosome by cytogenetics).
OUTLINE:
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.
Patients are followed every 6 months for 10 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of Newly Diagnosed Patients With BCR/ABL (+) Chronic Myelogenous Leukemia Treated With Combined Homoharringtonine (NSC #141633) and Low-Dose Cytarabine |
| Study Start Date : | March 1999 |
| Actual Primary Completion Date : | August 2003 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Treatment (omacetaxine mepesuccinate, cytarabine)
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
Given IV
Other Names:
Drug: cytarabine Given IV
Other Names:
Other: laboratory biomarker analysis Correlative studies |
- Complete cytogenetic, major cytogenetic, and hematologic response rate [ Time Frame: Up to 9 months ]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.
- Toxicity rates as assessed by Common Terminology Criterial version 2.0 [ Time Frame: Up to 9 months ]
- Duration of hematological response [ Time Frame: Up to 10 years ]Described with Kaplan-Meier curves.
- Time to hematological progression [ Time Frame: Up to 10 years ]Described with Kaplan-Meier curves.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003694
| United States, Massachusetts | |
| Dana-Farber Harvard Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Richard Stone | Cancer and Leukemia Group B |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003694 |
| Other Study ID Numbers: |
NCI-2012-02786 CALGB-19804 U10CA031946 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 5, 2003 Key Record Dates |
| Last Update Posted: | June 5, 2013 |
| Last Verified: | June 2013 |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Cytarabine Homoharringtonine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Protein Synthesis Inhibitors Enzyme Inhibitors |