Acute Myeloid Leukemia Clinical Trial
Official title:
Dose Escalation and Phase II Study of Bortezomib (IND #58443) Added to Standard Daunorubicin and Cytarabine Therapy for Patients With Previously Untreated Acute Myeloid Leukemia Age 60-75 Years
Verified date | June 2014 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This phase II trial studies the side effects and best dose of bortezomib when given together with daunorubicin and cytarabine and to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.
Status | Completed |
Enrollment | 95 |
Est. completion date | December 2012 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Unequivocally histologically confirmed acute myeloid leukemia (AML) - At least 20% blasts in the bone marrow based on WHO criteria - No acute promyelocytic leukemia (M3) - Antecedent hematologic disorder or myelodysplastic syndromes allowed provided the patient did not receive cytotoxic chemotherapy, including azacitidine and decitabine, for their pre-leukemic disorder - Concurrent enrollment on CALGB-8461 required - Not pregnant or nursing - Fertile patients must use effective contraception - No ataxia, cranial neuropathy, or peripheral neuropathy >= grade 2 - LVEF >= 40% by ECHO or MUGA scan - No signs or symptoms of congestive heart failure - DLCO >= 50% (corrected for hemoglobin) - No prior therapy for leukemia or pre-leukemic disorders, except for the following: - emergency leukapheresis; - emergency treatment for hyperleukocytosis with hydroxyurea; - cranial radiotherapy for CNS leukostasis (one dose only); - growth factor/cytokine support - No other concurrent chemotherapy, except for the following: - I) steroids administered for adrenal failure, hypersensitivity reactions, or septic shock; - II) hormones administered for non-disease-related conditions (e.g., insulin for diabetes or estrogens or progestins for gynecologic indications) - No concurrent palliative radiotherapy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | University of Chicago | Chicago | Illinois |
United States | University of Missouri - Ellis Fischel | Columbia | Missouri |
United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio |
United States | Kinston Medical Specialists PA | Kinston | North Carolina |
United States | North Shore University Hospital | Manhasset | New York |
United States | North Shore-LIJ Health System CCOP | Manhasset | New York |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | North Shore-LIJ Health System/Center for Advanced Medicine | New Hyde Park | New York |
United States | Mount Sinai Medical Center | New York | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Florida Hospital | Orlando | Florida |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Lombardi Comprehensive Cancer Center at Georgetown University | Washington | District of Columbia |
United States | Washington Hospital Center | Washington | District of Columbia |
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission Induction Response | Response was calculated according to Revised International Working Group (IWG) criteria for Acute myeloid leukemia (AML) A response was defined as the portion of participants who achieved a complete response (CR) or CR with incomplete platelet recovery(CRp) during induction. A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL). A CRp is defined as a CR except platelets < 100,000 mL without need for transfusion. |
2 months | No |
Primary | Participants Experiencing a Dose-limiting Toxicity (DLT) of Bortezomib When Administered in Combination With Intermediate-dose Cytarabine | DLTs were considered only during the first cycle of consolidation therapy and included grade 3 or 4 sensory or autonomic neuropathy, persistent grade 4 thrombocytopenia or neutropenia at day 42 in the absence of AML,any grade 4 or 5 nonhematologic toxicity, and any grade 3 nonhematologic toxicity (excluding neuropathy and toxicities secondary to neutropenia and sepsis) that did not resolve to grade 2 by day 42 unless attributable to persistent or recurrent AML. Grade 4 anorexia (requiring total parenteral nutrition) and grade 4 fatigue (requiring bed rest) were not considered DLTs. Toxicity was graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale is as follows: grade 1: mild; grade 2: moderate; grade 3: Severe; grade 4: Life Threatening; grade 5: Death. |
during consolidation cycle 1 (42 days) | Yes |
Secondary | Disease-free Survival | Disease-free survival (DFS) was measured as the interval from achievement of CR until relapse or death, regardless of cause. DFS was estimated using the Kaplan Meier method. | Duration of study (up to 10 years) | No |
Secondary | Overall Survival | Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method. | Duration of study (up to 10 years) | No |
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