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FLAC chemotherapy with GM-CSF
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.
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.
At a glance
| Generic name | FLAC chemotherapy with GM-CSF |
|---|---|
| Sponsor | National Cancer Institute (NCI) |
| Drug class | Multi-agent chemotherapy with cytokine support |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Acute myeloid leukemia (AML)
- Lymphoid malignancies
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Infection
- Mucositis
- Nausea and vomiting
- Diarrhea
- Fatigue
- Tumor lysis syndrome
Key clinical trials
- 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 (PHASE1)
- Combination Chemotherapy (FLAC) Combined With Granulocyte-Macrophage Colony Stimulating Factor in Locally Advanced and Metastatic Breast Cancer (PHASE2)
- 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 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FLAC chemotherapy with GM-CSF CI brief — competitive landscape report
- FLAC chemotherapy with GM-CSF updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI