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Allogeneic Transplantation From Related Haploidentical Donors

NCT00185692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-12-04

Study results available
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Summary

The purpose of the study is to evaluate the feasibility and safety of transplanting CD34+ selected hematopoietic cells from a haploidentical related donor following a nonmyeloablative regimen of total lymphoid irradiation (TLI) and antithymocyte globulin (ATG).

Conditions

Interventions

PROCEDURE

non-myeloablative hematopoietic cell transplantation

TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.

DRUG

Anti-Thymocyte Globulin

1.5 mg/kg QD x 5, IV. Dosage will be based on body weight. Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.

DRUG

Cyclosporine

6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).

DRUG

Mycophenolate Mofetil

15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively which blocks the de nobo synthesis of guanosine required for DNA synthesis and has an effect on T and B cells.

DRUG

G-CSF

16 mg/kg, SQ Growth factor used to make bone marrow produce more blood cells

DRUG

Solumedrol

1.0 mg/kg IV 2 hours prior to ATG Used to treat severe inflamation

DRUG

Acetaminophen

650 mg PO, 30 minutes prior to infusion Pain reliever

DRUG

Diphenydramine

50 mg IV, 30 minutes prior to infusion Used to relieve allergy symptoms

DRUG

Hydrocortisone

100 mg IV, 1 hour prior to infusion Used to relieve itching, redness and swelling of the skin

Sponsors & Collaborators

Principal Investigators

  • Robert Lowsky · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00185692 on ClinicalTrials.gov