Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sargramostim · 1 trial · 2 indications
Time from randomization to death. Patients alive at last follow-up were censored.
| Arm | Type | Description |
|---|---|---|
| Zosuquidar | EXPERIMENTAL | Induction treatment with daunorubicin, cytarabine and zosuquidar (details provided in Intervention section), followed by consolidation with Cytarabine (1500 mg/m2 every 12 hours for 6 days), then additional consolidation with the same regimen as received during induction. |
| Placebo | ACTIVE_COMPARATOR | Induction treatment with daunorubicin, cytarabine and placebo (details provided in Intervention section), followed by consolidation with Cytarabine (1500 mg/m2 every 12 hours for 6 days), then additional consolidation with the same regimen as received during induction. |
| Name | Type | Description |
|---|---|---|
| filgrastim | BIOLOGICAL | 250 μg/m2/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size. |
| sargramostim | BIOLOGICAL | 5 μg/kg/day by either intravenous or subcutaneous injection starting day 12, provided marrow aplasia is achieved, through recovery of absolute neutrophil count (ANC) to \> 500 cells/μl, sustained for 3 consecutive days. The dose may be rounded to the nearest vial size. |
| cytarabine | DRUG | 100 mg/m²/day by continuous intravenous infusion for 7 days (days 1-7). |
| daunorubicin hydrochloride | DRUG | 45 mg/m²/day by 10 - 15 minute intravenous infusion for 3 days (days 1, 2, and 3). |
| zosuquidar trihydrochloride | DRUG | Zosuquidar 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. |
| Placebo | DRUG | Placebo 550 mg/day by continuous intravenous infusion through a central venous catheter over approximately 6 hours on days 1, 2, and 3. The infusion will begin approximately one hour prior to daunorubicin on days 1, 2 and 3. Placebo consisted of a 1:1000 dilution of Infuvite, appropriately colored. |
Inclusion Criteria: One of the following disorders: * Acute myeloid leukemia (AML), defined as \>30% myeloblasts on the marrow aspirate or peripheral blood differential and any French-American-British (FAB) subtype except M3 (i.e., acute promyelocytic leukemia) * Refractory anemia with excess blas...
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Sargramostim is an investigational monoclonal antibody being studied for the treatment of leukemia, specifically in older patients with newly diagnosed acute myeloid leukemia or refractory anemia. It is being developed by Eli Lilly and Company and is currently in Phase 3 clinical development.
Sargramostim is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied in combination with chemotherapy drugs daunorubicin and cytarabine for the treatment of leukemia in older patients.
Sargramostim is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 3 clinical trials for the treatment of leukemia.
Sargramostim is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 449 patients with leukemia or myelodysplastic syndromes.
Sargramostim has been studied in one completed Phase 3 clinical trial, identified as NCT00046930. This trial evaluated the addition of sargramostim to daunorubicin and cytarabine in older patients with newly diagnosed acute myeloid leukemia or refractory anemia, enrolling 449 participants in the United States and Israel.