Study of PRO 140 for Prophylaxis of Acute GVHD in Patients Undergoing RIC Allogenic Stem-Cell Transplantaton (GVHD)
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|ClinicalTrials.gov Identifier: NCT02737306|
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Graft Vs Host Disease||Drug: PRO 140||Phase 2|
This is an open-label, single-arm, phase II, multicenter study to evaluate the feasibility of the use of PRO 140 as an add-on therapy to standard GVHD prophylaxis treatment for prevention of acute GVHD in adult patients undergoing RIC allogeneic HCT.
In this study, up to 60 subjects will be enrolled. PRO 140 will be administered as a 525 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for up to 100±7 days. Subjects will return to the clinic for three Follow-up visits at 2 weeks after the last treatment visit, 30 days after the last treatment visit and one year after the first treatment visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm, Phase II Multicenter Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Reduced Intensity Conditioning (RIC) Allogeneic Stem-Cell Transplantation|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: PRO 140
up to 60 subjects will be enrolled. PRO 140 will be administered as a 525 mg subcutaneous injection on Day -3 or Day -2 prior to stem cell infusion, on the day of stem cell infusion (Day 0), and then weekly for up to 100±7 days. Subjects will return to the clinic for three Follow-up visits at 2 weeks after the last treatment visit, 30 days after the last treatment visit and one year after the first treatment visit.
Drug: PRO 140
Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen.
Other Name: Humanized monoclonal antibody to CCR5
- Incidence of Grade II , Grade III or Grade IV acute GVHD by Day-100 [ Time Frame: 100 Days post treatment ]Primary Efficacy Endpoint
- Incidence of severe and life-threatening (Grade III and Grade IV) acute GVHD by Day-100 [ Time Frame: 100 Days post-treatment ]Secondary Efficacy Endpoint
- Incidence of organ-specific acute GVHD by Day-100 [ Time Frame: 100 Days post-treatment ]Secondary Efficacy Endpoint
- Donor engraftment evaluated by T-cell and myeloid chimerism in peripheral blood [ Time Frame: 365 days post-treatment (+/- 14 days) ]Secondary Efficacy Endpoint
- Neutrophil and Platelet count recovery [ Time Frame: 100 Days post treatment ]Secondary Efficacy Endpoint
- Changes in ECOG performance score [ Time Frame: 100 Days post treatment ]Secondary Efficacy Endpoint
- GVHD-free survival (GFS) [ Time Frame: 100 Days post treatment ]Secondary Efficacy Endpoint
- Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator-evaluation of injection site reactions [ Time Frame: 365 days post-treatment (+/- 14 days) ]Safety Assessment
- Frequency of treatment emergent adverse events and serious adverse events [ Time Frame: 100 Days post treatment ]Safety Assessment
- Hematologic malignancy relapse rate by Day-100 [ Time Frame: 100 Days post treatment ]Safety Assessment
- Changes and shifts in laboratory measurements over time [ Time Frame: 365 days post-treatment (+/- 14 days) ]
Safety Assessment- The laboratory measurements will include Routine CBC, Biochemistry and Urinalysis.
- Routine CBC includes hemoglobin, hematocrit (HCT), red blood cell (RBC) count, white blood cell (WBC) count, WBC differential count (%), absolute neutrophils count (ANC) and platelets count.
- Biochemistry profile includes assessment of Hepatic function indicators: total and direct bilirubin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, Lactate dehydrogenase (LDH); Renal function indicators: Blood Urea Nitrogen (BUN), creatinine; Electrolytes: sodium, potassium, chloride, calcium and bicarbonate; Other: glucose (random), cholesterol (total)
- Urinalysis for color, appearance, specific gravity, pH, protein, glucose, occult blood, ketones, RBC, WBC, epithelial cells, bacteria, casts, crystals
- Changes in Electrocardiogram (ECG) parameters over time [ Time Frame: 365 days post-treatment (+/- 14 days) ]Safety Assessment-The following ECG parameters will be evaluated: ventricular rate (beats per minute), PR interval (msec), QRS interval (msec), QT interval (msec), and QTc interval (msec).
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): NCT02737306
|Contact: Kush Dhody, MBBS, MSfirstname.lastname@example.org|
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