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Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML

NCT ID: NCT00462943

Last Updated: 2021-12-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-07

Study Completion Date

2013-06-27

Brief Summary

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A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.

Detailed Description

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This will be an open label, multicenter study of subcutaneous HHT (omacetaxine mepesuccinate) therapy of patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan.

Conditions

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Chronic Myeloid Leukemia

Keywords

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CML HHT Homoharringtonine Omacetaxine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OMA

Omacetaxine mepesuccinate (OMA) Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days for up to six cycles.

Omacetaxine mepesuccinate (OMA) Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days for up to 24 months.

Group Type EXPERIMENTAL

Omacetaxine mepesuccinate

Intervention Type DRUG

Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days.

Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days.

Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.

Interventions

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Omacetaxine mepesuccinate

Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days.

Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days.

Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.

Intervention Type DRUG

Other Intervention Names

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Homoharringtonine HHT Synribo OMA CGX-635

Eligibility Criteria

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Inclusion Criteria

* Male or female patients, age 18 years or older
* Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic, accelerated, or blast phase
* Patients will have either failed, demonstrated intolerance, or a combination of prior failure and intolerance, to prior treatments with at least two tyrosine kinase inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a response) or secondary resistance (loss of response).
* Acceptable Renal and Liver Function
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Sexually active patients and their partners must use an effective double barrier method of contraception

Exclusion Criteria

* New York Heart Association classification (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition
* Myocardial infarction in the previous 12 weeks.
* Other concurrent illness which would preclude study conduct and assessment
* uncontrolled and active infection, and positive HIV or positive HTLV I/II status, whether on treatment or not.
* Pregnant or lactating.
* Any medical or psychiatric condition, which may compromise the ability to give written informed consent or to comply with the study protocol.
* Lymphoid Ph+ blast crisis
* Patient is enrolled in another clinical investigation within 30 days of enrollment or is receiving another investigational agent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role collaborator

ChemGenex Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge Cortes, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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Teva Investigational Site 303

Los Angeles, California, United States

Site Status

Teva Investigational Site 308

Beech Grove, Indiana, United States

Site Status

Teva Investigational Site 311

Baltimore, Maryland, United States

Site Status

Teva Investigational Site 305

Buffalo, New York, United States

Site Status

Teva Investigational Site 302

The Bronx, New York, United States

Site Status

Teva Investigational Site 310

Philadelphia, Pennsylvania, United States

Site Status

Teva Investigational Site 301

Houston, Texas, United States

Site Status

Teva Investigational Site 314

Seattle, Washington, United States

Site Status

Teva Investigational Site 313

Montreal, , Canada

Site Status

Teva Investigational Site 309

Toronto, , Canada

Site Status

Teva Investigational Site 329

Bordeaux, , France

Site Status

Teva Investigational Site 321

Le Chesnay, , France

Site Status

Teva Investigational Site 322

Lille, , France

Site Status

Teva Investigational Site 320

Lyon, , France

Site Status

Teva Investigational Site 324

Nice, , France

Site Status

Teva Investigational Site 328

Paris, , France

Site Status

Teva Investigational Site 323

Poitiers, , France

Site Status

Teva Investigational Site 327

Strasbourg, , France

Site Status

Teva Investigational Site 325

Toulouse, , France

Site Status

Teva Investigational Site 331

Berlin, , Germany

Site Status

Teva Investigational Site 330

Mannheim, , Germany

Site Status

Teva Investigational Site 350

Budapest, , Hungary

Site Status

Teva Investigational Site 371

Hyderabad, , India

Site Status

Teva Investigational Site 370

Mumbai, , India

Site Status

Teva Investigational Site 390

Bologna, , Italy

Site Status

Teva Investigational Site 360

Gdansk, , Poland

Site Status

Teva Investigational Site 361

Warsaw, , Poland

Site Status

Teva Investigational Site 380

Singapore, , Singapore

Site Status

Teva Investigational Site 340

London, , United Kingdom

Site Status

Countries

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United States Canada France Germany Hungary India Italy Poland Singapore United Kingdom

References

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Cortes J, Digumarti R, Parikh PM, Wetzler M, Lipton JH, Hochhaus A, Craig AR, Benichou AC, Nicolini FE, Kantarjian HM; Omacetaxine 203 Study Group. Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors. Am J Hematol. 2013 May;88(5):350-4. doi: 10.1002/ajh.23408. Epub 2013 Mar 7.

Reference Type DERIVED
PMID: 23468307 (View on PubMed)

Other Identifiers

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2007-001286-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CGX-635-CML-203

Identifier Type: -

Identifier Source: org_study_id