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Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation

NCT02226861 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-07-05

No results posted yet for this study

Summary

Background:

\- Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations.

Objective:

\- To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD.

Eligibility:

* Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match.
* Donors: age 18 80.

Design:

* Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying.
* Donors will be screened with medical history, physical exam, blood tests and tissue typing.
* Recipients will stay in the hospital 3 6 weeks.
* All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm.
* Recipients will have:
* Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells.
* Bone marrow sample taken by needle. They will have 3 more after transplant.
* Donors will have:
* Filgrastim injected once daily for 5 6 days.
* Stem and immune cells collected by another apheresis.
* Recipients will get:
* Eight 30-minute doses of radiation, sitting at a machine.
* Donor immune cells by IV, 6 days before the transplant day.
* Chemotherapy drugs by IV.

\<TAB\>\<TAB\>- Donor stem cells by IV on transplant day.

* After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks.
* Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections
* Recipients must stay near NIH for 3 6 months after transplant.
* All recipients and donors will have 3 years of follow-up.

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML)
  • Chronic Lymphocytic Leukemia (CLL)
  • Chronic Myelogenous Leukemia (CML)
  • MDS

Interventions

DEVICE

CliniMACS CD34 selection system

Stem cells will be selected with the CliniMACS system before transplant.

BIOLOGICAL

ULD IL-2

sterile, white to off-white, preservative-free, lyophilized powder suitable for IV infusion upon reconstitution and dilution

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Sawa Ito, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-26
Primary Completion
2018-05-23
Completion
2018-06-27

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02226861 on ClinicalTrials.gov