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A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia


Phase 1/Phase 2
70 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

A Phase I/II Combination Study of Sapacitabine in Acute Myeloid Leukemia


Inclusion Criteria:



- Newly diagnosed AML based on WHO classification

- Age 70 years or older for whom the treatment of choice is low-intensity therapy by
investigator assessment or who has refused intensive induction therapy recommended by
investigator

- ECOG performance status 0-2

- Adequate renal function

- Adequate liver function

- Able to swallow capsules

- Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

- AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid
tumor without bone marrow involvement

- Having received any systemic anti-cancer therapy for AML or received treatment with
hypomethylating agents or cytotoxic chemotherapy for the preceding MDS or MPD

- Known central nervous system (CNS) involvement by leukemia

- Uncontrolled intercurrent illness including

- Known hypersensitivity to decitabine

- Known to be HIV-positive

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients who achieve a clinical benefit response including CR, CRp, PR and major HI

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

CYC682-11

NCT ID:

NCT01211457

Start Date:

June 2010

Completion Date:

June 2012

Related Keywords:

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

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Roswell Park Cancer InstituteBuffalo, New York  14263
Rush University Medical CenterChicago, Illinois  60612-3824