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VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies

NCT03885947 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-05-24

No results posted yet for this study

Summary

In this Phase I study, the study team will evaluate the safety of Valproic Acid (VPA) expanded cord blood stem cells defined by the lack of serious infusion reactions or graft failure in patients with hematological malignancies undergoing umbilical cord blood transplantation. Moreover, the study team will also evaluate time to neutrophil and platelet engraftment as well as transplant related outcomes such as graft versus host disease (GVHD), treatment related mortality (TRM), and overall survival (OS).

Conditions

Interventions

BIOLOGICAL

Cord blood stem cells

CD34 selected VPA expanded umbilical cord blood cells used in combination with or without unmanipulated umbilical cord blood .

DRUG

Valproic Acid

Valproic Acid (VPA) expanded cord blood stem cells

DRUG

Fludarabine

Fludarabine 150 mg/m2

DRUG

cytoxan

Cytoxan 50 mg/m2

DRUG

Thiotepa

Thiotepa 10 mg/m2

BIOLOGICAL

TBI

TBI 400cGy

Sponsors & Collaborators

  • Alla Keyzner

    lead OTHER

Principal Investigators

  • Alla Keyzner, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2021-03-10
Completion
2021-03-10
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 NCT03885947 on ClinicalTrials.gov