A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- The Emmes Company, LLC
- Enrollment
- 13
- Locations
- 4
- Primary Endpoint
- Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)
Study Overview
Brief Summary
The purpose of this study is to determine whether the addition of parathyroid hormone after a sequential cord blood transplant will improve engraftment, which is the ability of the transplanted stem cells to grow and to successfully begin producing new blood cells.
Detailed Description
In this phase II, single stage study, participants will include 40 adults who are candidates for a hematopoietic stem cell transplant. All participants will undergo a sequential cord blood transplant using a well-known myeloablative regimen of fludarabine, cyclophosphamide, and total body irradiation, which is appropriate for those individuals who are likely to benefit from an ablative regimen. Tacrolimus will be combined with mycophenolate mofetil (MMF) for the graft-versus-host disease (GVHD) prophylaxis regimen. Parathyroid hormone (PTH) will be added to this regimen in an attempt to improve engraftment. PTH is an approved drug with minimal side effects in individuals with osteoporosis; the dose of PTH has been determined from a phase I study in individuals with hematologic cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •One of the following diagnoses:
- •Chronic myelogenous leukemia (CML) accelerated phase or second stable phase; individuals in the first chronic phase are eligible if they have resistance to imatinib
- •Myelodysplasia
- •Aplastic anemia that is not responding to immunosuppressive therapy
- •Myelofibrosis, either primary or secondary to polycythemia vera
- •Relapsed lymphoma or Hodgkin's disease
- •Stage III/IV chronic lymphocytic leukemia (CLL), relapsed after or refractory to at least one fludarabine containing regimen
- •Acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) in complete remission (CR) 2 or greater, or CR 1 with high risk features
- •No prior autologous stem cell transplant
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than 2
- •Lack of 6/6 or 5/6 matched related donor OR lack of 10/10 matched unrelated donor OR no available donor in the appropriate time frame to perform a potentially curative stem cell transplant
- •Diffusing capacity of the lung for carbon monoxide (DLCO) greater than 50% of predicted value
- •Left ventricular ejection fraction (LVEF) greater than 50% of predicted value
- •Calcium levels less than 10.5 mg/dl
- •Phosphate levels greater than 1.6 mg/dl
Exclusion Criteria
- •Heart disease, as determined by symptomatic congestive heart failure, radionuclide ventriculogram (RVG), or echocardiogram-determined LVEF of less than 50%, active angina pectoris, or uncontrolled high blood pressure
- •Pulmonary disease, as determined by severe chronic obstructive lung disease, symptomatic restrictive lung disease, or corrected DLCO of less than 50% of predicted value
- •Kidney disease, as determined by serum creatinine levels greater than 2.0 mg/dl
- •Liver disease, as determined by serum bilirubin levels greater than 2.0 mg/dl (except in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be elevated greater than 2.0mg/dl), SGOT or SGPT greater than 3 times the upper limit of normal
- •Neurologic disease, as determined by symptomatic leukoencephalopathy, active central nervous system (CNS) cancer, or other neuropsychiatric abnormalities that may prevent transplantation (previous CNS cancer and presently in CR is acceptable)
- •HIV antibodies
- •Uncontrolled infection
- •Pregnant or breastfeeding
Arms & Interventions
Parathyroid Hormone (teriparatide)
Parathyroid hormone after double umbilical cord blood transplant.
Intervention: Parathyroid Hormone (teriparatide) (Drug)
Outcomes
Primary Outcomes
Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)
Time Frame: Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.
Median time to neutrophil engraftment (defined as an absolute neutrophil count \[ANC\] greater than 500)
Secondary Outcomes
- Cumulative Incidence of Acute GVHD Grades II-IV at Day 100(Measured at Day 100)
- Cumulative Incidence of Chronic GVHD(Measured at 2 years)
- Platelet Engraftment (Greater Than 20,000)(Measured at Day 180)
- 100-day Transplant-related Mortality(Measured at Day 100)
- Cumulative Incidence of Relapse(Measured at 2 years)
- Overall Survival(Measured at 2 years)
- Disease-free Survival(Measured at 1 year)