Status:
COMPLETED
Decitabine With or Without Bortezomib in Treating Older Patients With Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabin...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if treatment of older acute myeloid leukemia (AML) patients with decitabine and bortezomib significantly improves the overall survival times of older AML patients c...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Unequivocal pathologic diagnosis of AML (\>= 20% blasts in the bone marrow based on World Health Organization \[WHO\] criteria) EXCLUDING:
- Acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA
- Acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1 as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per Cancer and Leukemia Group B (CALGB) 20202; however patients who (1) are \>= 75 years; and/or (2) have an ejection fraction of \< 40%; and/or (3) have a performance status of \> 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and core-binding factor (CBF) molecular screening results from CALGB 20202
- Acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); CBFB-MYH11 as determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however patients who (1) are \>= 75 years; and/or (2) have an ejection fraction of \< 40%; and/or (3) have a performance status of \> 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202
- Absence of FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however patients who (1) are \>= 75 years; and/or (2) have an ejection fraction of \< 40%; and/or (3) have a performance status of \> 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202
- No prior treatment for AML except:
- Emergency leukapheresis
- Emergency treatment for hyperleukocytosis with hydroxyurea
- Cranial radiotherapy (RT) for central nervous system (CNS) leukostasis (one dose only)
- Growth factor/cytokine support
- AML patients with an antecedent hematologic disorder (AHD) or myelodysplastic syndrome (MDS) are eligible for this trial provided that they have not received treatment for their AHD or MDS with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.), decitabine, or bortezomib; patients may have been previously treated with azacitidine if their last dose was \>= 90 days prior to starting 11002
- AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for \> 6 months
Exclusion
Key Trial Info
Start Date :
November 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01420926
Start Date
November 16 2011
End Date
April 1 2021
Last Update
February 28 2023
Active Locations (53)
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1
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
3
Beebe Medical Center
Lewes, Delaware, United States, 19958
4
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718