Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00393380

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 II

MedlinePlus related topics: Anemia Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Spleen Diseases

Drug Information available for: Teriparatide Teriparatide acetate Parathyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500) [ Time Frame: Measured at Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute GVHD [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: No ]
Chronic GVHD [ Time Frame: Measured at 2 years ] [ Designated as safety issue: No ]
Platelet engraftment (greater than 20,000) [ Time Frame: Measured at Day 180 ] [ Designated as safety issue: No ]
Pre-engraftment transfusion support [ Time Frame: Measured at Day 42 ] [ Designated as safety issue: No ]
Percent donor chimerism [ Time Frame: Measured at Day 42 ] [ Designated as safety issue: No ]
100-day transplant-related mortality [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: No ]
Relapse [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
Disease-free survival [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Criteria

Inclusion Criteria:

One of the following diagnoses:
1. Chronic myelogenous leukemia (CML) accelerated phase or second stable phase; individuals in the first chronic phase are eligible if they have resistance to imatinib
2. Myelodysplasia
3. Aplastic anemia that is not responding to immunosuppressive therapy
4. Myelofibrosis, either primary or secondary to polycythemia vera
5. Relapsed lymphoma or Hodgkin's disease
6. Stage III/IV chronic lymphocytic leukemia (CLL), relapsed after or refractory to at least one fludarabine containing regimen
7. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393380

Locations

United States, California
University of California, San Diego
La Jolla, California, United States, 92093
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
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Responsible Party:	Massachusetts General Hospital ( Karen Ballen, MD )
Study ID Numbers:	435, U54 HL081030-02
Study First Received:	October 25, 2006
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00393380 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Myelogenous Leukemia, Chronic
Myelodysplasia
Parathyroid Hormone
Umbilical Cord Blood Stem Cell Transplantation

Study placed in the following topic categories:

Leukemia, Lymphoid
Teriparatide
Aplastic Anemia
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Leukemia, Myeloid, Acute
Hormones
Leukemia
Preleukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Metaplasia
Anemia, Aplastic
Hodgkin Disease
Lymphoma

Acute Lymphoblastic Leukemia
Myelofibrosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hematologic Diseases
Myelodysplastic Syndromes
Anemia
Myeloproliferative Disorders
Hodgkin's Disease
Leukemia, Myeloid
Myeloid Metaplasia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Additional relevant MeSH terms:

Leukemia, Lymphoid
Teriparatide
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Leukemia, Myeloid, Acute
Hormones
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Anemia, Aplastic
Lymphoma
Hodgkin Disease
Myelofibrosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type

Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myeloproliferative Disorders
Anemia
Leukemia, Myeloid
Pharmacologic Actions
Myeloid Metaplasia
Lymphatic Diseases
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, B-Cell
Bone Marrow Diseases
Lymphoproliferative Disorders
Splenic Diseases

ClinicalTrials.gov processed this record on May 07, 2009