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A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

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Trial Information

A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Percentage of Participants Achieving a Clinical Response by Subpopulation

Outcome Description:

Subpopulations reflect chronic myeloid leukemia (CML) phases: chronic, accelerated, and blast phase.

Outcome Time Frame:

up to 6 months

Safety Issue:

No

Principal Investigator

Jorge Cortes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CGX-635-CML-203

NCT ID:

NCT00462943

Start Date:

March 2007

Completion Date:

January 2014

Related Keywords:

  • Chronic Myeloid Leukemia
  • CML
  • HHT
  • Homoharringtonine
  • Omacetaxine
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Indiana Bone Marrow Transplant CenterBeech Grove, Indiana  46107
Our Lady Mercy Cancer CenterBronx, New York  10466
Fox Chase Temple BMT ProgramPhiladelphia, Pennsylvania  19111