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

Plain-language guide to NCT00393380: phase 2 interventional trial of Teriparatide, anemia, 13 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00393380
Phase: phase 2
Status: terminated early
Start: 2006-09
Completion (planned or actual): 2009-11
Participants: 13 (actual)
Design: na, open label (everyone knows who gets what), prevention
Conditions studied: Leukemia, Myeloid, Chronic; Anemia, Aplastic; Myelofibrosis; Lymphoma; Hodgkin Disease; Leukemia, Lymphocytic, Chronic
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Teriparatide for anemia.

It had 1 arm (groups): Parathyroid Hormone (teriparatide) (experimental).

The registry classes the interventions as drug.

More on the Plan

In this phase II, single stage study, participants will include 40 adults who are candidates for a hematopoietic stem cell transplant.

Tacrolimus will be combined with mycophenolate mofetil (MMF) for the graft-versus-host disease (GVHD) prophylaxis regimen.

Who Took Part

13 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Aplastic anemia that is not responding to immunosuppressive therapy. Myelofibrosis, either primary or secondary to polycythemia vera. Relapsed lymphoma or Hodgkin's disease.

The full record lists 15 inclusion and 8 exclusion criteria; among the exclusions: HIV antibodies; uncontrolled infection; pregnant or breastfeeding.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Teriparatide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-09 with completion listed for 2009-11.

It ran at 4 sites in United States (4).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500) (time frame: Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge).

It also tracked 7 secondary outcomes, for example Cumulative Incidence of Acute GVHD Grades II-IV at Day 100, Cumulative Incidence of Chronic GVHD, Platelet Engraftment (Greater Than 20,000), 100-day Transplant-related Mortality, Cumulative Incidence of Relapse and Overall Survival.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Teriparatide in 13 people with anemia.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, Anemia research.

Our Notes on the Compound

Teriparatide: A parathyroid hormone fragment, PTH(1-34), with human trials and approved-pen labeling; the research vial is not the approved pen.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.