{"id":"flac-chemotherapy-with-gm-csf","safety":{"commonSideEffects":[{"rate":null,"effect":"Myelosuppression (neutropenia, thrombocytopenia, anemia)"},{"rate":null,"effect":"Infection"},{"rate":null,"effect":"Mucositis"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Tumor lysis syndrome"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"FLAC is a multi-agent chemotherapy regimen where fludarabine and cytarabine are nucleoside analogs that inhibit DNA synthesis in rapidly dividing cells, and cyclophosphamide is an alkylating agent that cross-links DNA. GM-CSF is added as an immunostimulatory cytokine to promote myeloid cell proliferation and enhance immune-mediated tumor killing, potentially improving efficacy and reducing infection risk during chemotherapy-induced immunosuppression.","oneSentence":"FLAC chemotherapy combines fludarabine, cytarabine, and cyclophosphamide to kill cancer cells, while GM-CSF (granulocyte-macrophage colony-stimulating factor) boosts immune cell recovery and anti-tumor immunity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:46.136Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myeloid leukemia (AML)"},{"name":"Lymphoid malignancies"}]},"trialDetails":[{"nctId":"NCT00001269","phase":"PHASE1","title":"Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escalation of IL-3 (Interleukin-3) in Metastatic Breast Cancer","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1991-05","conditions":"Breast Neoplasms, Neoplasm Metastasis","enrollment":100},{"nctId":"NCT00001239","phase":"PHASE2","title":"Combination Chemotherapy (FLAC) Combined With Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1989-07","conditions":"Breast Cancer, Breast Neoplasms","enrollment":100},{"nctId":"NCT00001338","phase":"PHASE3","title":"A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy With GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1993-06","conditions":"Breast Neoplasms, Fever, Hematologic Diseases","enrollment":65}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"FLAC chemotherapy with GM-CSF","genericName":"FLAC chemotherapy with GM-CSF","companyName":"National Cancer Institute (NCI)","companyId":"national-cancer-institute-nci","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FLAC chemotherapy combines fludarabine, cytarabine, and cyclophosphamide to kill cancer cells, while GM-CSF (granulocyte-macrophage colony-stimulating factor) boosts immune cell recovery and anti-tumor immunity. Used for Acute myeloid leukemia (AML), Lymphoid malignancies.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}