Trial intelligence / Profile preview

Parathyroid Hormone for Engraftment after Cord Blood Transplant

NCT00393380Phase 2

Key facts

Status: Terminated
Start: Sep 2006
Primary completion: Nov 2009
Countries: 1
Sponsor: Emmes
Modality: Recombinant Proteins and Enzymes

Drugs: teriparatide
Conditions: chronic myeloid leukemia (CML)myelodysplastic syndrome (MDS)aplastic anemiamyelofibrosis (MF)Hodgkin lymphoma (HL)

Overview

Phase 2, open-label, single-arm trial of teriparatide in chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS), aplastic anemia and 5 more, sponsored by Emmes. Primary endpoint: Median Time to Neutrophil Engraftment (ANC > 500) at Day 42. Started Sep 2006; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Parathyroid Hormone (teriparatide)
Parathyroid hormone added to standard transplant regimen

Who it enrols

Adult candidates for hematopoietic stem cell transplant with various hematologic malignancies who lack a matched donor.

Endpoints

Primary

Median Time to Neutrophil Engraftment (ANC > 500)Day 42

Secondary

Cumulative Incidence of Acute GVHD Grades II-IVDay 100
Cumulative Incidence of Chronic GVHD2 years
Platelet Engraftment (> 20,000)Day 180
100-day Transplant-related MortalityDay 100
Cumulative Incidence of Relapse2 years
Overall Survival2 years
Disease-free Survival1 year

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