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

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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Leukemia, Myeloid, Chronic

Intervention

Parathyroid Hormone (teriparatide)

Study Arms / Comparison Groups

 Parathyroid Hormone (teriparatide)
Description:  Parathyroid hormone after double umbilical cord blood transplant.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

13

Start Date

September 2006

Completion Date

March 2012

Primary Completion Date

November 2009

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
      

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Karen K. Ballen, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00393380

Organization ID

435

Secondary IDs

U54HL081030-02

Responsible Party

Sponsor

Study Sponsor

The Emmes Company, LLC

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Karen K. Ballen, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

April 2013