At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of hematological malignancy undergoing related donor haploidentical HCT
- ✓Age ≥18 years
- ✓Bilirubin ≤2× ULN (or ≤3× ULN if Gilbert's syndrome or suspected mild veno-occlusive disease)
- ✓Adequate renal function: serum creatinine clearance >30 mL/min by Cockcroft-Gault
- ✕Availability of HLA-identical sibling donor or volunteer adult unrelated donor matched at HLA-A, -B, -C, -DRB1
- ✕Active AML/MDS disease (>5% blasts in bone marrow and/or circulating leukemic blasts)
- ✕Active CNS involvement with leukemia/lymphoma or lymphoma with progressive disease on imaging
- ✕Serious medical or psychiatric illness that could interfere with treatment completion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation
In Brief
A Phase 2 clinical trial evaluating Evomela, Fludarabine, and 2 other interventions for Hematological Malignancy and Multiple Myeloma. Completed, enrolled 43 participants across 1 site.
Detailed Summary
This is an open-label, single-arm, phase II study to determine the safety of propylene glycol-free melphalan HCl (EVOMELA®), in combination with fludarabine and total-body irradiation-based reduced-intensity conditioning for haploidentical transplantation. In addition, the study evaluates the one-year progression-free survival of patients undergoing this treatment.
Study Details
Timeline
Interventions
140 mg/m\^2/day IV on Day -6 for patients who are \< 60 years of age. 70 mg/m\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \>3
40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2
200 cGy on Day: -1
This is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.