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Sorafenib Tosylate and Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
Phase 2 trial testing Biopsy in Acute Myeloid Leukemia With FLT3/ITD Mutation in 54 participants. Completed in 15 April 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 | 54 |
| Start date | 1 April 2011 |
| Primary completion | 31 October 2014 |
| Estimated completion | 15 April 2021 |
| Sites | 43 locations across United States |
National Cancer Institute (NCI)
60 and older, any sex, with Acute Myeloid Leukemia With FLT3/ITD Mutation or Acute Myeloid Leukemia With Inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11. 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 patients who were alive at 1 year. The analysis was split between patients with having a FLT3 (FMS-like tyrosine kinase-3) ITD (internal tandem duplication) or TKD (tyrosine kinase domain) mutation. The FLT3 mutation testing at baseline was performed centrally for all patients.
| Group | Value | 95% CI |
|---|---|---|
| ITD Mutated Participants | 62 | 45 – 78 |
| TKD Mutated Participants | 71 | 42 – 92 |
OS was defined as the time from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
| Group | Value | 95% CI |
|---|---|---|
| ITD Mutated Participants | 15 | 10.4 – 20.1 |
| TKD Mutated Participants | 16.2 | 5.0 – NA |
Event-free survival (EFS) was defined as the time for registration to failure to achieve CR during induction, relapse or death. Participants without events were censored at date of last follow-up. The median EFS with 95% CI was estimated using the Kaplan Meier method.
| Group | Value | 95% CI |
|---|---|---|
| ITD Mutated Participants | 8.8 | 3.0 – 13.9 |
| TKD Mutated Participants | 7.8 | 1.3 – 11.6 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Daunorubicin, C… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Platelet count decreased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| White blood cell decreased | Investigations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Lung infection | Infections and infestations | — |
| Alanine aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Sepsis | Infections and infestations | — |
| Reaction | System | Treatment (Daunorubicin, C… |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| White blood cell decreased | Investigations | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| Hypertension | Vascular disorders | — |
| Headache | Nervous system disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Fever | General disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| INR increased | Investigations | — |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | — |
| Hypotension | Vascular disorders | — |
| Creatinine increased | Investigations | — |
| Anxiety | Psychiatric disorders | — |
Most-reported serious reactions: Anemia, Platelet count decreased, Neutrophil count decreased, Diarrhea, White blood cell decreased, Febrile neutropenia, Hypoalbuminemia, Fatigue.
Data from ClinicalTrials.gov NCT01253070 adverse events section.
This phase II trial studies how well sorafenib tosylate and chemotherapy work in treating older patients with acute myeloid leukemia (AML). Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 or by stopping them from dividing. Giving sorafenib tosylate and combination chemotherapy may be an effective treatment for AML.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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