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

NCT00393380 | Terminated Phase 2 Results DMC

• 2 other identifiers: 435U54HL081030-02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• 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

Study Arms (1)

Parathyroid Hormone (teriparatide)

EXPERIMENTAL

Parathyroid hormone after double umbilical cord blood transplant.

Drug: Parathyroid Hormone (teriparatide)

Interventions

Parathyroid Hormone (teriparatide) DRUG

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

Also known as: Parathyroid hormone, PTH, teriparatide

Parathyroid Hormone (teriparatide)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Emmes Company, LLC: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

University of Florida

Gainesville, Florida, 32610, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Ballen K, Mendizabal AM, Cutler C, Politikos I, Jamieson K, Shpall EJ, Dey BR, Attar E, McAfee S, Delaney C, McCarthy P, Ball ED, Kamble R, Avigan D, Maziarz RT, Ho VT, Koreth J, Alyea E, Soiffer R, Wingard JR, Boussiotis V, Spitzer TR, Antin JH. Phase II trial of parathyroid hormone after double umbilical cord blood transplantation. Biol Blood Marrow Transplant. 2012 Dec;18(12):1851-8. doi: 10.1016/j.bbmt.2012.06.016. Epub 2012 Jul 2.

  PMID: 22766223 DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Anemia, Aplastic; Primary Myelofibrosis; Lymphoma; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anemia, Refractory, with Excess of Blasts

Interventions

Parathyroid Hormone; Teriparatide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia; Bone Marrow Failure Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Anemia, Refractory; Myelodysplastic Syndromes

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study was closed prematurely due to early mortality and lack of efficacy.

Results Point of Contact

• Title: Adam Mendizabal, Statistician
• Organization: The EMMES Corporation

amendizabal@emmes.com

301-251-1161

Study Officials

• 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 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 27, 2006
• Study Start: September 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: March 1, 2012
• Last Updated: April 29, 2013
• Results First Posted: December 7, 2012

Record last verified: 2013-04

Locations

US (4)