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Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation

NCT03159702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-01-27

Study results available
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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.

Conditions

Interventions

DRUG

Evomela

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

DRUG

Fludarabine

40 mg/ m\^2/day intravenous on Days: -5 -4, -3, -2

RADIATION

Total Body Irradiation

200 cGy on Day: -1

OTHER

Haploidentical Hematopoietic Cell Transplantation

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Mehdi Hamadani · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2024-11-12
Completion
2025-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159702 on ClinicalTrials.gov