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Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor

Primary Purpose

Leukemia, Myeloid, Chronic, Anemia, Aplastic, Myelofibrosis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Parathyroid Hormone (teriparatide)

About this trial

This is an interventional prevention trial for Leukemia, Myeloid, Chronic focused on measuring Myelogenous Leukemia, Chronic, Myelodysplasia, Parathyroid Hormone, Umbilical Cord Blood Stem Cell Transplantation

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Florida
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parathyroid Hormone (teriparatide)

Arm Description

Parathyroid hormone after double umbilical cord blood transplant.

Outcomes

Primary Outcome Measures

Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)

Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)

Secondary Outcome Measures

Cumulative Incidence of Acute GVHD Grades II-IV at Day 100

Cumulative Incidence of Acute GVHD Grades II-IV at day 100

Cumulative Incidence of Chronic GVHD

Platelet Engraftment (Greater Than 20,000)

Platelet engraftment (greater than 20,000)

100-day Transplant-related Mortality

100-day transplant-related mortality

Cumulative Incidence of Relapse

Overall Survival

Disease-free Survival

Disease-free survival

Full Information

NCT ID

NCT00393380

First Posted

October 25, 2006

Last Updated

April 22, 2013

Sponsor

The Emmes Company, LLC

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT00393380

Brief Title

Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor

Official Title

A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

Study stopped because of toxicity concerns.

Study Start Date

September 2006 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Emmes Company, LLC

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Chronic, Anemia, Aplastic, Myelofibrosis, Lymphoma, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, Leukemia, Myelocytic, Acute, Leukemia, Lymphocytic, Acute

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parathyroid Hormone (teriparatide)

Arm Type

Experimental

Arm Description

Parathyroid hormone after double umbilical cord blood transplant.

Intervention Type

Drug

Intervention Name(s)

Parathyroid Hormone (teriparatide)

Other Intervention Name(s)

Parathyroid hormone, PTH, teriparatide

Intervention Description

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

Primary Outcome Measure Information:

Title

Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)

Description

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.

Secondary Outcome Measure Information:

Title

Cumulative Incidence of Acute GVHD Grades II-IV at Day 100

Description

Cumulative Incidence of Acute GVHD Grades II-IV at day 100

Time Frame

Measured at Day 100

Title

Cumulative Incidence of Chronic GVHD

Description

Cumulative Incidence of Chronic GVHD

Time Frame

Measured at 2 years

Title

Platelet Engraftment (Greater Than 20,000)

Description

Platelet engraftment (greater than 20,000)

Time Frame

Measured at Day 180

Title

100-day Transplant-related Mortality

Description

100-day transplant-related mortality

Time Frame

Measured at Day 100

Title

Cumulative Incidence of Relapse

Description

Cumulative Incidence of Relapse

Time Frame

Measured at 2 years

Title

Overall Survival

Description

Overall Survival

Time Frame

Measured at 2 years

Title

Disease-free Survival

Description

Disease-free survival

Time Frame

Measured at 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: