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Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors

NCT03615105 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-04-06

Study results available
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Summary

This study is being done to learn whether a new method to prevent rejection between the donor immune system and the patient's body is effective.

Conditions

Interventions

RADIATION

Hyperfractionated total body irradiation

Hyperfractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).

DRUG

Thiotepa

Thiotepa 5 mg/kg IV

DRUG

Cyclophosphamide

Cyclophosphamide 60 mg/kg IV

DRUG

Busulfan

Busulfan (adult/ped dose)

DRUG

Fludarabine

Fludarabine 25 mg/m2 IV

DRUG

Melphalan

Melphalan 70 mg/m2 IV

DRUG

Clofarabine

Clofarabine 20-30 mg/m2 IV

PROCEDURE

HPC(A) stem cell allograft

All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.

DRUG

Rituximab

Rituximab 200 mg IV flat dose

DEVICE

Rabbit antithymocyte globulin

Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.

Sponsors & Collaborators

Principal Investigators

  • Brian Shaffer, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-25
Primary Completion
2024-03-06
Completion
2024-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03615105 on ClinicalTrials.gov