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CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome

NCT03393611 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-12-21

No results posted yet for this study

Summary

This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory AML or myelodysplastic syndrome.

Conditions

  • Myelodysplastic Syndromes
  • Leukemia, Myeloid, Acute
  • Leukemia, Relapsed Adult Acute Myeloid
  • Myelodysplastic Syndromes, Previously Treated

Interventions

DRUG

CPX-351

Salvage Chemotherapy: CPX-351 at 120 u/m2 on Days -21, -19, and -17

DRUG

Fludarabine

Fludarabine 150 mg/m2 (30 mg/m2/day x 5 days, Day -7 to Day -3)

DRUG

Melphalan

Melphalan 140 mg/m2 (Day -2)

DRUG

Rabbit Anti-Human T-Lymphocyte Globulin

Rabbit ATG (rATG)-thymoglobulin 4.5 mg/kg (1.5 mg/kg/day x 3 days)

BIOLOGICAL

Haplo-Cord Stem Cell Transplantation

Allogeneic stem cell transplantation using a haploidentical donor and umbilical cord blood unit.

Sponsors & Collaborators

Principal Investigators

  • Sebastian Mayer, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2021-08-30
Completion
2021-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03393611 on ClinicalTrials.gov