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In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus

NCT01453140 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-04-08

Study results available
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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

Conditions

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.

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Michele Donato, MD · Hackensack Meridian Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-03-31
Completion
2012-07-31

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 NCT01453140 on ClinicalTrials.gov