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Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Phase 3 trial testing Daunorubicin in Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome in 727 participants. Completed in 21 December 2022.
| Lead sponsor | ECOG-ACRIN Cancer Research Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 727 |
| Start date | 4 February 2011 |
| Primary completion | 22 February 2021 |
| Estimated completion | 21 December 2022 |
| Sites | 269 locations across United States, Israel, India |
ECOG-ACRIN Cancer Research Group
60 and older, any sex, with Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome or Adult Acute Megakaryoblastic Leukemia (M7). Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall survival is defined as the time from randomization to death or date last known alive.
| Group | Value | 95% CI |
|---|---|---|
| A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant) | 12.9 | 11.0 – 14.9 |
| B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant) | 11.6 | 9.8 – 14.1 |
Patients are required to have all of the following to be considered as having a completion remission (CR). * Peripheral Blood Counts 1. Neutrophil count \> 1.0 x 10\^9 /L 2. Platelet count ≥ 100 x 10\^9 /L 3. Reduced hemoglobin concentration or hematocrit has no bearing on remission status 4. Leukemic blasts must not be present in the peripheral blood * Bone Marrow Aspirate and Biopsy 1. Cellularity of bone marrow biopsy must be \> 20% with maturation of all cell lines 2. \< 5% blasts by morphologic review 3. Auer rods must not be detectable * Extramedullary leukemia, such as
| Group | Value | 95% CI |
|---|---|---|
| A (Step 1:Daunorubicin/Cytarabine; Step 2:Cytarabine; Step 3: Observation/Decitabine/Transplant) | 0.446 | 0.394 – 0.499 |
| B (Step 1: Clofarabine; Step 2: Clofarabine; Step 3: Observation/Decitabine/Transplant) | 0.453 | 0.401 – 0.506 |
Overall survival is defined as time between achieving leukemia-free state after induction therapy to death from any cause or date last known alive. The association between overall survival and donor status was evaluated regardless of assigned treatment arms. Patients with transplant donor information (either had donor or did not have a donor) reported after achieving CR/Cri/leukemia-free state post induction therapy were included in this analysis.
| Group | Value | 95% CI |
|---|---|---|
| With Transplant Donor | 27.2 | 15.3 – NA |
| Without Transplant Donor | 12.9 | 10.3 – 17.0 |
DFS for maintenance comparison is defined as the time from maintenance randomization until relapse or death of any cause. The censored follow-up time for patients without relapse and death information is the date of last contact. Only patients who remained in CR or CRi after completion of consolidation therapy that were randomized to either observation or decitabine in the maintenance Step were included in this analysis.
| Group | Value | 95% CI |
|---|---|---|
| Maintenance : Observation | 8.2 | 5.1 – 18.7 |
| Maintenance : Decitabine | 16.3 | 10.1 – 26.3 |
Time frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Induction: Daunorub… | Arm B (Induction: Clofarab… | Arm C (Consolidation: Cyta… | Arm D (Consolidation: Clof… | Arm E (Maintenance: Observ… | Arm F (Maintenance: Decita… | Arm G (Transplant) |
|---|---|---|---|---|---|---|---|---|
| White blood cell decreased | Investigations | — | — | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — | — |
| Lung infection | Infections and infestations | — | — | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — | — | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — | — | — |
| Infections and infestations - Other | Infections and infestations | — | — | — | — | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Catheter related infection | Infections and infestations | — | — | — | — | — | — | — |
| Reaction | System | Arm A (Induction: Daunorub… | Arm B (Induction: Clofarab… | Arm C (Consolidation: Cyta… | Arm D (Consolidation: Clof… | Arm E (Maintenance: Observ… | Arm F (Maintenance: Decita… | Arm G (Transplant) |
|---|---|---|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — | — | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
| Creatinine increased | Investigations | — | — | — | — | — | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — | — | — | — | — | — |
Most-reported serious reactions: White blood cell decreased, Platelet count decreased, Neutrophil count decreased, Anemia, Febrile neutropenia, Lymphocyte count decreased, Aspartate aminotransferase increased, Alanine aminotransferase increased.
Data from ClinicalTrials.gov NCT02085408 adverse events section.
This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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