Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

November 30, 2020

Study Completion Date

November 30, 2020

Conditions
Aplastic AnemiaHypoplastic Myelodysplastic Syndrome
Interventions
DRUG

BL-8040

Subjects will receive subcutaneous (SC) injections of BL-8040 monotherapy on days 1-10 of the study. Beginning on Month 2 day 1, (M2/D1), and continuing monthly through Month 6, BL-8040 will be administered daily as part of the maintenance period for the first 5 days of each month.

DRUG

horse anti-thymocyte globulin (hATG)

From Day 11 through Day 14 of first month, subjects will receive hATG infusion over 6-8 hours each day.

DRUG

Methylprednisolone

From Day 11-14 of first month, subjects receive infusion of methylprednisolone 30 minutes prior to hATG infusion. Treatment with methylprednisolone will continue for 30 days. (After day 14, subjects may receive oral prednisone dose equivalent to IV methylprednisolone dose. The oral dose will be tapered off over 30 days.

DRUG

Cyclosporine

From Day 11 through end of treatment (Month 6 Day 30), subjects will receive oral dose of cyclosporine.

Trial Locations (1)

77030

MD Anderson Cancer Center, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioLineRx, Ltd.

INDUSTRY

NCT02462252 - Phase IIA Open Label Study to Evaluate Efficacy and Safety of BL-8040 Followed by (hATG), Cyclosporine and Methyprednisolone in Adult Subjects With Aplastic Anemia or Hypoplastic Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter