Preemptive Therapy of GVHD
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|ClinicalTrials.gov Identifier: NCT01994824|
Recruitment Status : Suspended (Toxicity concern upon preliminary analysis, requiring putting study on hold and re-doing the preliminary analysis with longer follow up.)
First Posted : November 26, 2013
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Graft-vs-host Disease||Drug: rabbit antithymocyte globulin||Phase 2|
Blood for IL15 and IL2Ra determination will be drawn in the morning of day 7 (10 ml red top tube). IL15 and IL2Ra levels will be measured in Storek/Khan Lab by enzyme-linked immunosorbent assay (ELISA) as described (Pratt LM et al: BMT 2013). Storek/Khan Lab staff will report the IL15 and IL2Ra levels to the Bone Marrow Transplant ward (Unit 57, Foothills Medical Centre) no later than in the morning of day 8. If the IL15 level is <31 ng/L or the IL2Ra level is >4500 ng/L, the physician caring for the patient on the ward will order Thymoglobulin, 3 mg/kg intravenously, to be infused over 4-8 hours on day 8. The dose is based on actual body weight, and is rounded to the nearest vial (Thymoglobulin is supplied in 25 mg vials) except if the rounding would result in >5% difference from the calculated dose. Unit 57 standard practice will be followed for the infusion of ATG (see Standard Operation Procedure BMTS40153 ["ATG Administration"]). Premedication for ATG will include methylprednisolone 40 mg IVPB, acetaminophen 1000 mg PO and diphenhydramine 50 mg IVPB. Acetaminophen 1000 mg PO and diphenhydramine 50 mg IVPB can be repeated in 4-6 hours PRN flu-like symptoms/fever/chills. Meperidine 25-50 mg IVPB every 4 hours will be given PRN for rigors.
EVALUATIONS For the endpoint of the incidence of significant GVHD, patients will be followed per standard practice of the Alberta Blood and Marrow Transplant Program for the development of acute and chronic GVHD (www.albertahealthservices.ca/hp/if-hp-cancer-guide-bmt-manual.pdf). Per this standard practice, acute GVHD is graded according to Consensus criteria (Przepiorka D: BMT 1995) and chronic GVHD is diagnosed and graded according to NIH criteria (Filipovich AH: BBMT 2005). Significant GVHD is defined as grade 2-4 acute GVHD or chronic GVHD needing systemic immunosuppressive therapy.
For the endpoint of survival free of significant GVHD and relapse, relapse will be defined by standard criteria (eg, >5% marrow blasts by morphology in case of acute leukemia).
For the endpoint of quality of life at 2 years (21-27 months) posttransplant, Short Form 36 will be used.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preemptive Therapy of Graft-vs-Host Disease Using Rabbit Antithymocyte Globulin|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Intervention arm
Transplant recipients will have IL15 and IL2Ra measured on day 7. If at risk for significant GVHD, the patient will get rabbit antithymocyte globulin, 3 mg/kg on day 8.
Patients from this intervention/experimental arm will be compared to historical and concurrent controls (no ATG on day 8).
Drug: rabbit antithymocyte globulin
Thymoglobulin, 3 mg/kg, will be given on day 8 posttransplant to patients at high risk of significant GVHD per day 7 IL15 and IL2Ra levels.
Other Name: Thymoglobulin
- Cumulative incidence of significant GVHD [ Time Frame: 2 years ]
- Survival free of relapse and significant GVHD [ Time Frame: 2 years ]
- Quality of life [ Time Frame: 2 years ]
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): NCT01994824
|Alberta Health Services-CancerControl / University of Calgary / University of Alberta (Edmonton)|
|Calgary, Alberta, Canada, T2N 4N1|
|Principal Investigator:||Jan Storek, MD, PhD||University of Calgary|