Overview

A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD

Status:
Terminated
Trial end date:
2018-05-03
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI involvement.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baxalta now part of Shire
Baxalta US Inc.
Collaborator:
Kamada, Ltd.
Treatments:
Alpha 1-Antitrypsin
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Protease Inhibitors
Criteria
Inclusion Criteria:

1. Male or female participants aged ≥18 years at the time of screening

2. Recipient of an hematopoietic stem cell transplantation (HSCT)

3. The disease indication for which the participant required HSCT must be in remission

4. Newly diagnosed acute graft-versus-host disease (GvHD), including lower
Gastrointestinal (GI) involvement (modified International Bone Marrow Transplant
Registry [IBMTR] Severity Stage 1 to 4 [>500 mL diarrhea/day]), with or without other
organ system involvement.

5. Willing to undergo or must have had a lower GI biopsy within 7 days of informed
consent to confirm GI GvHD. Biopsy results are not needed to initiate treatment;
however, if biopsy results are not consistent with aGvHD, treatment with GLASSIA will
be discontinued.

6. Participants must be receiving systemic corticosteroids. Treatment with
methylprednisolone/systemic steroids must have been initiated within 72 hours prior to
the first dose of study treatment after enrollment

7. Evidence of myeloid engraftment (absolute neutrophil count ≥0.5 x 10^9/L)

8. Lower GI GvHD manifested by diarrhea must have other causes of diarrhea ruled out (eg,
negative for Clostridium difficile or cytomegalovirus [CMV] infection or oral
magnesium administration)

9. Karnofsky Performance Score ≥50%

10. If female of childbearing potential, participant presents with a negative blood
pregnancy test

11. Females of childbearing potential with a fertile male sexual partner must agree to
employ adequate contraception for the duration of the study.

12. Males must use adequate contraception and must not donate sperm for the duration of
the study.

13. Participant is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

1. Participant with manifestations of chronic GvHD

2. Participant with acute/chronic GvHD overlap syndrome

3. Participant whose GvHD developed after donor lymphocyte infusion

4. Participant with myocardial infarction within 6 months prior to enrollment or New York
Heart Association Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities. Prior to the first dose of study
treatment, any electrocardiogram (ECG) abnormality at screening must be documented by
the investigator as not medically relevant

5. Participant with evidence of recurrent malignancy

6. Participant with veno-occlusive disease (ie, sinusoidal obstruction syndrome)

7. Participant receiving GvHD treatment other than continued prophylaxis (eg,
cyclosporine and/or mycophenolate mofetil, etc) or corticosteroid therapy. In
addition, a participant who received the first dose of corticosteroid therapy for
acute GvHD with lower GI involvement more than 72 hours before the first dose of study
treatment is not eligible for the study

8. Participant with severe sepsis involving at least 1 organ failure

9. Participant who is seropositive or positive in the nucleic acid test for human
immunodeficiency virus (HIV)

10. Participant with active hepatitis B or C

11. Participant has participated in another clinical study involving an investigational
product (IP) or investigational device within 30 days prior to enrollment or is
scheduled to participate in another clinical study involving an IP or investigational
device during the course of this study

12. If female, participant is pregnant or lactating at the time of enrollment, or has
plans to become pregnant during the study

13. Participant with a serious medical or psychiatric illness likely to interfere with
participation in the study

14. Participant is a family member or employee of the investigator