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

The EMMES Corporation

Status and phase

Terminated

Phase 2

Conditions

Myelofibrosis

Anemia, Aplastic

Leukemia, Myeloid, Chronic

Leukemia, Lymphocytic, Acute

Leukemia, Myelocytic, Acute

Hodgkin Disease

Lymphoma

Leukemia, Lymphocytic, Chronic

Treatments

Drug: Parathyroid Hormone (teriparatide)

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00393380

435

U54HL081030-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No 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