Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myeloid, Chronic Anemia, Aplastic Myelofibrosis Lymphoma Hodgkin Disease Leukemia, Lymphocytic, Chronic Leukemia, Myelocytic, Acute Leukemia, Lymphocytic, Acute |
Drug: Parathyroid Hormone (teriparatide) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation |
- 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. ] [ Designated as safety issue: No ]Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)
- Cumulative Incidence of Acute GVHD Grades II-IV at Day 100 [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: No ]Cumulative Incidence of Acute GVHD Grades II-IV at day 100
- Cumulative Incidence of Chronic GVHD [ Time Frame: Measured at 2 years ] [ Designated as safety issue: No ]Cumulative Incidence of Chronic GVHD
- Platelet Engraftment (Greater Than 20,000) [ Time Frame: Measured at Day 180 ] [ Designated as safety issue: No ]Platelet engraftment (greater than 20,000)
- 100-day Transplant-related Mortality [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: No ]100-day transplant-related mortality
- Cumulative Incidence of Relapse [ Time Frame: Measured at 2 years ] [ Designated as safety issue: No ]Cumulative Incidence of Relapse
- Overall Survival [ Time Frame: Measured at 2 years ] [ Designated as safety issue: No ]Overall Survival
- Disease-free Survival [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]Disease-free survival
| Enrollment: | 13 |
| Study Start Date: | September 2006 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Parathyroid Hormone (teriparatide)
Parathyroid hormone after double umbilical cord blood transplant.
|
Drug: Parathyroid Hormone (teriparatide)
Day +1: PTH 40 mcg, Day +2: PTH 60 mcg, Day +3: PTH 80 mcg, Day +4 to Day +29 or until ANC>2000/microL: PTH 100 mcg
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Karen K. Ballen, MD | Massachusetts General Hospital |
| Principal Investigator: | Joseph Antin, MD | Dana-Farber Cancer Institute |
| Principal Investigator: | David Avigan, MD | Beth Israel Deaconess Medical Center |
| Principal Investigator: | Elizabeth J Shpall, MD | MD Anderson Cancer Research Center |
| Principal Investigator: | Colleen Delaney, MD | Fred Hutchinson Cancer Research Center |
| Principal Investigator: | Ram Kamble, MD | Baylor College of Medicine |
| Principal Investigator: | Katarzyna Jamieson, M.D. | University of Florida |
| Principal Investigator: | Philip McCarthy, M.D. | Roswell Park Cancer Institute |
| Principal Investigator: | Edward Ball, M.D. | University of California, San Diego |
| Principal Investigator: | Richard Maziarz, M.D. | Oregon Health and Science University |
More Information
No publications provided by The EMMES Corporation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The EMMES Corporation |
| ClinicalTrials.gov Identifier: | NCT00393380 History of Changes |
| Other Study ID Numbers: | 435, U54HL081030-02 |
| Study First Received: | October 25, 2006 |
| Results First Received: | November 6, 2012 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The EMMES Corporation:
|
Myelogenous Leukemia, Chronic Myelodysplasia Parathyroid Hormone Umbilical Cord Blood Stem Cell Transplantation |
Additional relevant MeSH terms:
|
Primary Myelofibrosis Anemia Anemia, Aplastic Hodgkin Disease Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoma Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Hormones Teriparatide Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 21, 2013