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Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Phase 2 trial testing Cytarabine in Acute Myeloid Leukemia in 61 participants. Completed in 15 March 2021.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 61 |
| Start date | 14 December 2010 |
| Primary completion | 1 July 2013 |
| Estimated completion | 15 March 2021 |
| Sites | 65 locations across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Acute Myeloid Leukemia or Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of participants who were alive 30 days after starting induction treatment.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 97 | 89 – 99.6 |
Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The 1 year EFS rate with 95% CI was estimated using the Kaplan-Meier method, Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts).
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 83 | 70.7 – 90.5 |
Percentage of participants who achieve a CR. Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts).
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 90 | 80 – 96 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 15 |
Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The 3 year DFS rate with 95% CI was estimated using the Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 75 | 63 – 89 |
Overall survival (OS) is defined as time from registration to death. The 3 year OS rate with 95% CI was estimated using the Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib) | 77 | 66 – 89 |
Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Daunorubicin Hy… |
|---|---|---|
| Platelet count decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Neutrophil count decreased | Investigations | — |
| Fatigue | General disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Lymphocyte count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Headache | Nervous system disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Creatinine increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Blood bilirubin increased | Investigations | — |
| Fever | General disorders | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Reaction | System | Treatment (Daunorubicin Hy… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Headache | Nervous system disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Fever | General disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| INR increased | Investigations | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Edema limbs | General disorders | — |
| Blood bilirubin increased | Investigations | — |
| Activated partial thromboplastin time prolonged | Investigations | — |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | — |
| Sinus tachycardia | Cardiac disorders | — |
| Electrocardiogram QT corrected interval prolonged | Investigations | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Infections and infestations - Other | Infections and infestations | — |
| Hyperuricemia | Metabolism and nutrition disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Platelet count decreased, Anemia, Neutrophil count decreased, Fatigue, Hypoalbuminemia, Nausea, Hyperglycemia, Febrile neutropenia.
Data from ClinicalTrials.gov NCT01238211 adverse events section.
This phase II trial studies the side effects and how well giving combination chemotherapy together with dasatinib works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin hydrochloride and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with dasatinib may kill more cancer cells.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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