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

NCT ID: NCT00393380

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Parathyroid Hormone (teriparatide)

Parathyroid hormone after double umbilical cord blood transplant.

Group Type: EXPERIMENTAL

Parathyroid Hormone (teriparatide)

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Parathyroid hormone; PTH; teriparatide

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen K. Ballen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Joseph Antin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

David Avigan, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Elizabeth J Shpall, MD

Role: PRINCIPAL_INVESTIGATOR

MD Anderson Cancer Research Center

Colleen Delaney, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Ram Kamble, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Katarzyna Jamieson, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Philip McCarthy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Edward Ball, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Richard Maziarz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

University of Florida

Gainesville, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22766223 (View on PubMed)

Other Identifiers

U54HL081030-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

435

Identifier Type: -

Identifier Source: org_study_id

NCT00579722

Identifier Type: -

Identifier Source: nct_alias