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TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation

NCT01300611 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-12-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of TXA127 on neutrophil and platelet counts in adult patients who have undergone a double cord blood transplant. The study will also evaluate the effect of TXA127 on chemotherapy-induced mucositis, an inflammation of the mucous membranes in the digestive tract (mouth to anus) and immune reconstitution which helps patients fight infections. For patients undergoing CBT, both neutrophil and platelet normalization and immune reconstitution can be delayed. TXA127 has shown to be well tolerated by patients and appears to induce a rapid production of neutrophils and platelets in the bloodstream as well as increase the immune system components. It has also been shown to reduce the severity of chemotherapy-induced mucositis.

Conditions

Interventions

DRUG

TXA127 300 mcg/kg/day

Injection, 300 mcg/kg/day for 28 days

DRUG

TXA127 1000 mcg/kg/day

Injection, 1000 mcg/kg/day for 28 days

Sponsors & Collaborators

  • Constant Therapeutics LLC

    collaborator INDUSTRY

  • Tarix Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Uday R Popat, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01300611 on ClinicalTrials.gov