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Fludarabine and Melphalan
Fludarabine and melphalan are cytotoxic chemotherapy agents that work together to damage cancer cell DNA and suppress bone marrow function in preparation for hematopoietic stem cell transplantation.
Fludarabine and melphalan are cytotoxic chemotherapy agents that work together to damage cancer cell DNA and suppress bone marrow function in preparation for hematopoietic stem cell transplantation. Used for Conditioning regimen for allogeneic hematopoietic stem cell transplantation in hematologic malignancies, Lymphoma and leukemia patients undergoing stem cell transplantation.
At a glance
| Generic name | Fludarabine and Melphalan |
|---|---|
| Also known as | Busulfex and Fludara, Fludara and Alkeran |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Drug class | Cytotoxic chemotherapy combination (purine analog + alkylating agent) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Fludarabine is a purine analog that inhibits DNA synthesis and repair in rapidly dividing cells, while melphalan is an alkylating agent that cross-links DNA strands. When combined, they provide intensive myeloablative conditioning to eliminate malignant hematopoietic cells and suppress the immune system to reduce transplant rejection risk. This combination is commonly used as a reduced-intensity conditioning regimen prior to allogeneic stem cell transplantation.
Approved indications
- Conditioning regimen for allogeneic hematopoietic stem cell transplantation in hematologic malignancies
- Lymphoma and leukemia patients undergoing stem cell transplantation
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Mucositis
- Nausea and vomiting
- Infection
- Graft-versus-host disease (GVHD)
- Hepatotoxicity
Key clinical trials
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation (PHASE1, PHASE2)
- HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide (PHASE2)
- Total Marrow and Lymphoid Irradiation, Fludarabine, and Melphalan Before Donor Stem Cell Transplant in Treating Participants With High-Risk Acute Leukemia or Myelodysplastic Syndrome (PHASE1)
- Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML/MDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial (PHASE3)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Reduced MBF Regimen for Patients >=55 Years With Myeloid Malignancies (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |