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Stem Cell Transplantation From HLA Partially-Matched Related Donors for Patients With Hematologic Malignancies

NCT02566395 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-07

No results posted yet for this study

Summary

This clinical pilot trial is intended to evaluate the feasibility, efficacy and safety of hematopoietic stem cell transplantation (HSCT) from Human Leukocyte Antigen (HLA)-mismatched related donors for children and young adults with hematologic malignancies who lack a suitably matched related or unrelated donor. The methodology will be one that has been successfully utilized in adult patients at Thomas Jefferson University.

Conditions

Interventions

RADIATION

Radiation

1,200 cGy, delivered in 8 fractions of 150 cGy bid x 4 days

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg IV daily x 2 consecutive days

BIOLOGICAL

Donor Lymphocyte Infusion (DLI)

DLI containing 1 x 10E8/kg donor T-cells

BIOLOGICAL

Haploidentical Stem Cell Transplantation

2-10 x 10E6/kg donor CD34+ selected cells

Sponsors & Collaborators

  • New York Blood Center

    collaborator OTHER

  • Northwell Health

    lead OTHER

Principal Investigators

  • Joel A Brochstein, MD · Cohen Children's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2022-01-14
Completion
2022-02-14

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 NCT02566395 on ClinicalTrials.gov