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An open-label, phase II trial of PKC412 monotherapy in patients with acute myeloid leukemia and patients with myelodysplastic syndrome



An open-label, phase II trial of PKC412 monotherapy in patients with acute myeloid leukemia and patients with myelodysplastic syndrome

For Condition: Acute Myeloid Leukemia,Myelodysplastic Syndrome
Status: Recruiting
Sponsor(s): Novartis Pharmaceuticals , Dana-Farber/Harvard Cancer Center,Memorial Sloan-Kettering Cancer Center,M.D. Anderson Cancer Center
Synopsis: Patients who agree to participate in this trial will be screened for the FLT 3 mutation. If positive they will have a physical exam, blood test, EKG, chest x-ray, bone marrow aspirate and a pregnancy test. Patients will be required to have weekly blood test and bone marrow aspirate monthly.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Patients: with AML who are not candidates for myelosuppressive chemotherapy or with AML who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with MDS subtypes RAEB, RAEB-T or CMML. - Who 0-2 - FLT 3 mutation - AML (MDS patients exempted) must have a total WBC (including blast) of > 5,000 - Patients must have a serum creatinine of < 1.5 x ULN, SGOT/SGPT < 3 x ULN and total bilirubin < 2.0 x ULN
Total Enrollment: 20

Location and Contact Information:

M.D. Anderson Cancer Center *Not yet recruiting*
Houston,  Texas, 
United States
Not yet recruiting Eli  Estey 713-792-7544

Memorial Sloan Kettering Cancer Center *Recruiting*
New York City,  New York, 
United States
Recruiting Virginia  Klimek 212-639-6519

Dana-Farber Cancer Institute *Recruiting*
Boston,  Massachusetts, 
United States
Recruiting Ilene  Galinsky 617-632-3902


Additional Information:
Study ID Numbers:
  PKC4122104; 
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045942

Other Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia

2. Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia

3. Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation

4. Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

5. Intensive Compared With Nonintensive Chemotherapy in Treating Older Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome

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An open-label, phase II trial of PKC412 monotherapy in patients with acute myeloid leukemia and patients with myelodysplastic syndrome

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