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Expanded Cord Blood Cell Infusion Following Combination Chemotherapy in Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT01701323 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-03-01

No results posted yet for this study

Summary

This pilot clinical trial studies infusion of expanded cord blood hematopoietic progenitor cells following combination chemotherapy in treating younger patients with acute myeloid leukemia that has relapsed or has not responded to treatment. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemotherapy also kills healthy infection-fighting cells, increasing the risk of infection. The infusion of expanded cord blood hematopoietic progenitor cells may be able to replace blood-forming cells that were destroyed by chemotherapy. This cellular therapy may decrease the risk of infection following chemotherapy.

Conditions

Interventions

BIOLOGICAL

Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion

Given IV

DRUG

Cytarabine

Given IV

DRUG

Filgrastim

Given SC or IV

DRUG

Fludarabine Phosphate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    collaborator OTHER

  • Nohla Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ann Dahlberg · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-10
Primary Completion
2018-05-10
Completion
2018-05-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01701323 on ClinicalTrials.gov