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A Phase I Clinical Study of CWP232291 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome Having Failed Hypomethylating Treatment, and High-Risk Myelofibrosis

Phase 1
18 Years
Open (Enrolling)
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myelofibrosis

Thank you

Trial Information

A Phase I Clinical Study of CWP232291 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia-2, Myelodysplastic Syndrome Having Failed Hypomethylating Treatment, and High-Risk Myelofibrosis

Inclusion Criteria:

- Able to understand and willing to sign an informed consent form (ICF) prior to
initiation of any study-specific procedure and treatment

- 18 years of age

- 3. A pathologically confirmed diagnosis of AML or CMML-2 by World Health Organization
(WHO) classification that is relapsed or refractory or for which no current therapies
are anticipated to result in a durable remission, or MDS by WHO classification are
RAEB-1 or RAEB-2 and that have failed at least three cycles of hypomethylating
therapy, or primary (PMF), post-polycythemia vera (PPMF) or post-essential
thrombocythemia (PTMF) MF by WHO classification, are high-risk category by the
Dynamic International Prognostic Scoring System (DIPSS Plus), have ≥1% circulating
blasts, and have failed treatment with ruxolitinib

- Eastern Cooperative Oncology Group (ECOG) performance score 0-2

- In the absence of rapidly progressing disease, the interval from prior treatment to
time of study drug administration should be at least 2 weeks for cytotoxic agents or
at least 5 half-lives for noncytotoxic agents. If a patient is on hydroxyurea to
control peripheral blood leukemic cell counts, the patient must have discontinued
hydroxyurea for at least 24 hours before initiation of treatment with study drug.
Persistent clinically significant toxicities from prior chemotherapy must not be
greater than grade 1

- Adequate renal function:

- Serum creatinine =/< 2.0mg/dL

- Adequate hepatic function:

- Total bilirubin <1.5 x upper limit of normal (ULN), unless considered due to
Gilbert's syndrome

- Alkaline phosphatase (AP) =/< 2.5 x ULN

- Aspartate transaminase (AST) or alanine transaminase (ALT) ≤3 x ULN, unless
considered due to organ leukemic involvement

- Women of child-bearing potential (i.e., women who are pre menopausal or not
surgically sterile) must use acceptable contraceptive methods (abstinence,
intrauterine device [IUD], oral contraceptive, or double barrier device), and must
have a negative serum or urine pregnancy test within 2 weeks prior to beginning
treatment on this trial. Sexually active men must also use acceptable contraceptive
methods for the duration of time on study

- Able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

- Uncontrolled intercurrent illness including, but not limited to, uncontrolled
infection, symptomatic congestive heart failure (CHF), cardiac arrhythmia, or
psychiatric illness/social situation that would limit compliance with study

- Active heart disease including myocardial infarction (MI) within previous 3 months,
symptomatic coronary artery disease (CAD), arrhythmias not controlled by medication,
or uncontrolled CHF

- Active central nervous system (CNS) disease

- Therapy with any other standard or investigational treatment for hematologic
malignancy (except hydroxyurea, as mentioned in the inclusion criteria)

- Therapy with anticoagulant or antithrombotic agents (including aspirin) within 7 days
prior to study drug administration

- History of gastrointestinal (GI) hemorrhage

- Known positive status for human immunodeficiency virus (HIV) and/or active hepatitis
B or C

- Pregnant or nursing women. Pregnant and nursing patients are excluded because the
effects of CWP232291 on a fetus or nursing child are unknown.

- Patients eligible for bone marrow transplant, regardless of age

- Patients with FLT3 ITD positive AML or AML patients with other cytogenetic
abnormalities who are eligible for trials of other targeted investigational agents
from which the investigator feels there is greater benefit.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

If myelosuppression is DLT (Dose-Limiting Toxicity), it will be monitored up to 42 days after start of injection.

Outcome Time Frame:

Up to 3 weeks after start of injection

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

February 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Primary Myelofibrosis
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute



Mayo Clinic Rochester, Minnesota  55905
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009