Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
TERMINATED
NCT01453140
PHASE1/PHASE2

In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus

Sponsor: Hackensack Meridian Health

View on ClinicalTrials.gov

Summary

In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine

Official title: Phase I- II Study of in Vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for the Treatment of Steroid-refractory Acute Graft-versus-host Disease

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2011-08

Completion Date

2012-07

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide and Sirolimus

On the first day of treatment, cyclophosphamide will be administered at a dose of 4g/m2 IV x 1 dose. Patients who are \>40% above ideal weight will be dosed based on adjusted weight and adjusted BSA. One day after the administration of cyclophosphamide, patients will receive sirolimus 6 mg PO x 1 and on the following day will start sirolimus at a dose of 2 mg PO daily.

DRUG

Low dose IL-2 with Cytoxan + Sirolimus

Patients in treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus. IL-2 will be administered at a dose of 0.5E6 IU/m2 SQ daily x 8 weeks followed by 4 weeks off, starting 14 days after the cyclophosphamide.

DRUG

Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus

Patients in treatment arm C will be receiving low-dose azacitidine (Vidaza). The Vidaza will be initiated between day 27 and 32 following the cyclophosphamide. The dose administered will be 10 mg SQ daily for 5 days followed by 3 weeks off.

DRUG

Cyclophosphamide and Sirolimus

Day 1: Cyclophosphamide Day 2: Sirolimus

DRUG

Low dose IL-2 with Cytoxan + Sirolimus

treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus

DRUG

Low dose IL-2, Vidaza, Cytoxan & Sirolimus

Vidaza will be initiated between day 27 and 32 following the cyclophosphamide.

Locations (1)

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States