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Reduced Intensity Conditioning and Haploidentical Related Bone Marrow for Patients With Hematologic Diseases

NCT02145039 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-12-26

Study results available
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Summary

This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen, consisting of fludarabine, cyclophosphamide and low dose total body irradiation (TBI), is designed for the treatment of patients with advanced and/or high risk diseases.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.

DRUG

Cyclophosphamide

Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.

RADIATION

Total Body Irradiation

TBI 200cGy on day -1 before transplant.

BIOLOGICAL

Haploidentical stem cell transplant

Non-T-cell depleted bone marrow infusion

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Claudio Brunstein, MD · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-01-31
Completion
2019-01-31

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 NCT02145039 on ClinicalTrials.gov