Denosumab in Treating Patients with Bone Loss due to Donor Stem Cell Transplant

Status: Approved

Description

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 Criteria

Inclusion Criteria

  • The patient has undergone an allogeneic hematopoietic stem cell transplant
  • The patient has completed a base line dual x-ray absorptiometry (DXA) scan =< 3 months prior to transplantation
  • The patient has completed a post-transplant DXA scan at day 100 (+/- 30 days) post transplantation
  • The patients’ post-transplantation DXA scan denotes one or more of the following: * >= 5% decrease in bone mineral density (g/cm^2) in either the dual femur or lumbar spine (average of L1-L4), or both, between the pre-hematopoietic stem cell transplant (HSCT) and ~ day + 100 post-HSCT DXA scans * Osteopenia in either the dual femur or lumbar spine (L1-L4) at either the pre-HSCT or day + 100 post-HSCT timepoint * Osteoporosis in either the dual femur or lumbar spine (L1-L4) at either the pre-HSCT or day + 100 post-HSCT timepoint
  • The patient has completed and passed a dental clearance exam for administration of denosumab
  • 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 or legal representative 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

Exclusion Criteria

  • The patient has a history of a hypersensitivity reaction to denosumab
  • The patient has a history of osteonecrosis of the jaw
  • The patient has predisposing risk factors for hypocalcemia including the following: * Hypoparathyroidism * Creatinine clearance (CrCl) < 30 mL/min * Dialysis * Malabsorption syndrome
  • The patient has history of any bone fracture =< 30 days prior to denosumab therapy
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive study drug including relapsed malignancy

Locations & Contacts

New York

Buffalo
Roswell Park Cancer Institute
Status: Approved
Contact: Philip L. McCarthy
Phone: 716-845-8412
Email: philip.mccarthy@roswellpark.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To evaluate the efficacy and safety of denosumab therapy for the treatment of bone loss in patients who have received an allogeneic hematopoietic stem cell transplant.

OUTLINE:

Patients receive 2 doses of denosumab subcutaneously (SC) between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up at 6 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Supportive care

Lead Organization

Lead Organization
Roswell Park Cancer Institute

Principal Investigator
Philip L. McCarthy

Trial IDs

Primary ID I 78618
Secondary IDs NCI-2019-01921
Clinicaltrials.gov ID NCT03925532