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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00393380
• Other study ID #: 435
• Secondary ID: U54HL081030-02
• Status: Terminated
• Phase: Phase 2
• First received: October 25, 2006
• Last updated: April 22, 2013
• Start date: September 2006
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: The EMMES Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00579722

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2012
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia, Aplastic
• Hodgkin Disease
• Leukemia
• Leukemia, Lymphocytic, Acute
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelocytic, Acute
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, Myeloid, Chronic
• Lymphoma
• Myelofibrosis
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
The EMMES Corporation	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.	No
Secondary	Cumulative Incidence of Acute GVHD Grades II-IV at Day 100	Cumulative Incidence of Acute GVHD Grades II-IV at day 100	Measured at Day 100	No
Secondary	Cumulative Incidence of Chronic GVHD	Cumulative Incidence of Chronic GVHD	Measured at 2 years	No
Secondary	Platelet Engraftment (Greater Than 20,000)	Platelet engraftment (greater than 20,000)	Measured at Day 180	No
Secondary	100-day Transplant-related Mortality	100-day transplant-related mortality	Measured at Day 100	No
Secondary	Cumulative Incidence of Relapse	Cumulative Incidence of Relapse	Measured at 2 years	No
Secondary	Overall Survival	Overall Survival	Measured at 2 years	No
Secondary	Disease-free Survival	Disease-free survival	Measured at 1 year	No