A Phase II Multicenter, Single Arm, Open-Label Trial to Evaluate the Efficacy and Safety of Denosumab in Treatment of Post-Allogenic Hematopoietic Stem Cell Transplant Bone Loss

Who is this study for? Patients who have undergone an allogeneic hematopoietic stem cell transplant
What treatments are being studied? Denosumab
Status: Active, not recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• The patient has undergone an Allogeneic Hematopoietic Stem Cell Transplant

• The patient has completed a base line dual x-ray absorptiometry (DXA) scan =< 6 months prior to transplantation

• The patient has completed a post-transplant DXA scan at day 100 (+/- 30 days) or up to 6 months post transplantation

• The patient has completed and passed a dental clearance exam up to 6 months prior to transplant or 6 months after transplant

• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Locations
United States
New York
Roswell Park Cancer Institute
Buffalo
Ohio
Cleveland Clinic
Cleveland
Time Frame
Start Date: December 19, 2019
Estimated Completion Date: January 29, 2023
Participants
Target number of participants: 30
Treatments
Experimental: Supportive Care (denosumab)
Patients receive 2 doses of denosumab SC between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity.
Authors
Philip L McCarthy, Betty Hamilton
Related Therapeutic Areas
Sponsors
Collaborators: Amgen
Leads: Roswell Park Cancer Institute

This content was sourced from clinicaltrials.gov

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