In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for Steroid-refractory Acute Graft-versus-host Disease (T-REG)
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|ClinicalTrials.gov Identifier: NCT01453140|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : July 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Drug: Cyclophospahmide and Sirolimus Drug: Low dose IL-2, Cyclophosphamide and Sirolimus Drug: Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||July 2012|
Experimental: Cyclophosphamide and Sirolimus
Patients will be treated in sequential cohorts of 5. In cohort A, the first 5 enrolled patients will be receive cyclophosphamide and sirolimus only
Drug: Cyclophospahmide 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.
Other Name: Cytoxan
|Experimental: Low dose IL-2 with Cytoxan + Sirolimus||
Drug: Low dose IL-2, Cyclophosphamide and 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.
|Experimental: Low dose IL-2, Vidaza, Cytoxan & Sirolimus||
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.
- The primary objective of this study is to determine the response rate of patients treated steroid-refractory GVHD using cyclophospahmide and sirolimus combined with 3 variations of low-dose IL 2 and low-dose Vidaza. [ Time Frame: 28 days to 100 days post transplant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01453140
|United States, New Jersey|
|John Theurer Cancer Center at Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Michele Donato, MD||Hackensack Meridian Health|