In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus
NCT ID: NCT01453140
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
3 participants
INTERVENTIONAL
2011-08-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cyclophosphamide and Sirolimus
cyclophosphamide and sirolimus combo
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.
Cyclophosphamide and Sirolimus
Day 1: Cyclophosphamide Day 2: Sirolimus
Lowdose IL-2, Cytoxan + Sirolimus
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.
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.
Low dose IL-2 with Cytoxan + Sirolimus
treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus
Lowdose IL-2, Vidaza, cyclophosphamide & Sirolimus
Lowdose IL-2, Vidaza, cyclophosphamide (Cytoxan) \& Sirolimus Patients in treatment arm C will be receiving low-dose azacitidine (Vidaza).
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.
Low dose IL-2, Vidaza, Cytoxan & Sirolimus
Vidaza will be initiated between day 27 and 32 following the cyclophosphamide.
Interventions
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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.
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.
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.
Cyclophosphamide and Sirolimus
Day 1: Cyclophosphamide Day 2: Sirolimus
Low dose IL-2 with Cytoxan + Sirolimus
treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus
Low dose IL-2, Vidaza, Cytoxan & Sirolimus
Vidaza will be initiated between day 27 and 32 following the cyclophosphamide.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be steroid-refractory defines as progression after 3 days of corticosteroid therapy or no response after 5 days of corticosteroid therapy.
* Progression is defined as up-grading
* No response is defined as no down-grading
* Progression after 3 days requires patients to have received at least 2 mg/mg/day for a total of 6 mg/kg of methylprednisolone or its equivalent.
* No response after 5 days requires patient to have received at least 2 mg/kg/d for a total of 10 mg/kg of methylprednisolone or its equivalent.
* Patients with exacerbation of GVHD during steroid taper will require re-treatment with 2mg/kg/d of corticosteroids and will need to meet the criteria
* Age 18-70
* Patients must have received an allogeneic hematopoietic stem cell transplant within 100 days of study enrollment.
* Serum creatinine \< 2 mg/dL
Exclusion Criteria
* Patients must not have received cyclophosphamide for GVHD prophylaxis
* Patients must not have pneumonia requiring oxygen supplementation
* Unable or unwilling to sign informed consent.
18 Years
70 Years
ALL
No
Sponsors
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Hackensack Meridian Health
OTHER
Responsible Party
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Principal Investigators
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Michele Donato, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Countries
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Other Identifiers
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TREG - Pro2219
Identifier Type: -
Identifier Source: org_study_id
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