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

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.

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

• 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

United States
New York
Roswell Park Cancer Institute
Cleveland Clinic
Time Frame
Start Date: December 19, 2019
Estimated Completion Date: January 29, 2023
Target number of participants: 30
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.
Philip L McCarthy, Betty Hamilton
Related Therapeutic Areas
Collaborators: Amgen
Leads: Roswell Park Cancer Institute

This content was sourced from clinicaltrials.gov

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