NCT02226861

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

Completed Phase 1 Last updated 5 July 2018

What this trial tests

Phase 1 trial testing CliniMACS CD34 selection system in Acute Lymphoblastic Leukemia (ALL) in 24 participants. Completed in 27 June 2018.

Timeline

26 August 2014

Primary endpoint
23 May 2018

27 June 2018

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	26 August 2014
Primary completion	23 May 2018
Estimated completion	27 June 2018
Sites	1 location across United States

Drugs / interventions tested

• CliniMACS CD34 selection system
• ULD IL-2 — full drug profile →

Conditions studied

• Acute Lymphoblastic Leukemia (ALL) — all drugs for Acute Lymphoblastic Leukemia (ALL) →
• Acute Myelogenous Leukemia (AML) — all drugs for Acute Myelogenous Leukemia (AML) →
• Chronic Lymphocytic Leukemia (CLL) — all drugs for Chronic Lymphocytic Leukemia (CLL) →
• Chronic Myelogenous Leukemia (CML) — all drugs for Chronic Myelogenous Leukemia (CML) →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 75, any sex, with Acute Lymphoblastic Leukemia (ALL) or Acute Myelogenous Leukemia (AML). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanistic approaches for the prevention and treatment of chronic GVHD.
   Cutler CS, Koreth J, Ritz J. · · 2017 · cited 86× · PMID 27821505 · DOI 10.1182/blood-2016-08-686659
2. Successful salvage chemotherapy and allogeneic transplantation of an acute myeloid leukemia patient with disseminated <i>Fusarium solani</i> infection.
   Sheela S, Ito S, Strich JR, Manion M, et al · · 2017 · cited 5× · PMID 28794968 · DOI 10.1016/j.lrr.2017.07.001
3. Persistence of skewed X-chromosome inactivation in pre-B acute lymphoblastic leukemia of a female ATRX mutation carrier.
   Bradley CP, Chen C, Oetjen KA, Yan C, et al · · 2019 · cited 3× · PMID 31501157 · DOI 10.1182/bloodadvances.2019000013
4. Dynamics of neoantigen-specific T-cells in post-transplant relapse: do leukemia neoantigens elicit immune responses in transplant recipients?
   Neupane B, Ventura K, Parr K, Lee JR, et al · · 2025 · PMID 39881205 · DOI 10.1038/s41409-025-02515-3
5. High angiopoietin-2 and suppression of tumorigenicity-2 levels correlate with onset of sinusoidal obstructive syndrome-implication for the utility of serial biomarker monitoring.
   Nunes AT, Jain P, Kleiner DE, Shah NN, et al · · 2017 · PMID 28287645 · DOI 10.1038/bmt.2017.38