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A Phase I Dose Escalation Study of Intravenous Decitabine in Combination With Oral Bexarotene in Patients With Acute Myeloid Leukemia (AML)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Myeloid, Acute

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Trial Information

A Phase I Dose Escalation Study of Intravenous Decitabine in Combination With Oral Bexarotene in Patients With Acute Myeloid Leukemia (AML)


The investigators are seeking to study the combination of decitabine and bexarotene. These
two agents have each shown efficacy in decreasing leukemic blast counts and restoring normal
hematopoiesis via different mechanisms of action and with non-overlapping side-effect
profiles. By combining these agents, the investigators hope to improve overall response
rates. The investigators further hope to improve platelet and neutrophil counts in an even
greater number of patients, thus treating two of the most important sources of morbidity and
mortality in this patient population.


Inclusion Criteria:



- AML with bone marrow blasts ≥ 20%.

- Relapsed disease after 1 or more lines of prior salvage chemotherapy and any FAB-AML,
or

- Diagnosis of AML and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any
FAB-AML except FAB-M3.

- Performance status ≤ 2.

- Age ≥ 18 years.

Exclusion Criteria:

- Peripheral white blood cell count (WBC) > 10,000/microliter.

- Total bilirubin > 1.5 x normal.

- AST/ALT > 2.5 x normal.

- Serum creatinine > 2 x normal.

- Fasting serum triglyceride > 1,000 mg/dL.

- Active or poorly controlled graft vs host disease (GVHD).

- Pregnant or nursing.

- Known CNS leukemia.

- History of positive HIV serology.

- History of positive Hepatitis C serology.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, congestive heart failure of NYHA class 3 or 4, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situation that would limit
compliance with study requirements.

- Chemotherapy within 21 days of enrollment.

- Radiation therapy within 14 days of enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of combination decitabine and bexarotene during four cycles of therapy

Outcome Time Frame:

After 4 cycles of therapy

Safety Issue:

Yes

Principal Investigator

Amanda Cashen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

09-1661 / 201012801

NCT ID:

NCT01001143

Start Date:

March 2010

Completion Date:

March 2015

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110