Trial Outcomes & Findings for Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor (NCT NCT00393380)

Results Overview

Median time to neutrophil engraftment (defined as an absolute neutrophil count \[ANC\] greater than 500)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.

Results posted on

2013-04-29

Participant Flow

Thirteen patients were enrolled on the study between October 25, 2006 and March 27, 2008 from three centers. Dana Farber Cancer Institute enrolled 10 patients, University of Florida enrolled 2 patients and Massachusetts General Hospital enrolled 1 patient.

Thirteen patients who were enrolled proceeded to the cord blood transplant.

Participant milestones

Participant milestones
Measure	Parathyroid Hormone (Teriparatide) Parathyroid hormone after double umbilical cord blood transplant.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	39 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.

Population: 13 patients received the transplant.

Median time to neutrophil engraftment (defined as an absolute neutrophil count \[ANC\] greater than 500)

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)	30 days Interval 19.0 to 37.0

SECONDARY outcome

Timeframe: Measured at Day 100

Population: 13 patients were transplanted

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

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Cumulative Incidence of Acute GVHD Grades II-IV at Day 100	38.5 percentage of participants Interval 10.3 to 66.7

SECONDARY outcome

Timeframe: Measured at 2 years

Population: 13 patients were transplanted.

Cumulative Incidence of Chronic GVHD

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Cumulative Incidence of Chronic GVHD	38.5 percentage of participants Interval 8.1 to 68.9

SECONDARY outcome

Timeframe: Measured at Day 180

Population: 13 patients were transplanted.

Platelet engraftment (greater than 20,000)

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Platelet Engraftment (Greater Than 20,000)	46.2 percentage of participants Interval 17.0 to 76.0

SECONDARY outcome

Timeframe: Measured at Day 100

Population: 13 patients were transplanted

100-day transplant-related mortality

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
100-day Transplant-related Mortality	4 participants

SECONDARY outcome

Timeframe: Measured at 2 years

Population: 13 patients were transplanted.

Cumulative Incidence of Relapse

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Cumulative Incidence of Relapse	15.4 percentage of participants Interval 0.0 to 36.2

SECONDARY outcome

Timeframe: Measured at 2 years

Population: 13 patients were transplanted.

Overall Survival

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Overall Survival	38.5 percentage of participants Interval 14.1 to 62.8

SECONDARY outcome

Timeframe: Measured at 1 year

Population: 13 patients were transplanted.

Disease-free survival

Outcome measures

Outcome measures
Measure	Parathyroid Hormone (Teriparatide) n=13 Participants Parathyroid hormone after double umbilical cord blood transplant.
Disease-free Survival	38.5 percentage of participants Interval 14.1 to 62.8

Adverse Events

Parathyroid Hormone (Teriparatide)

Serious events: 8 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Parathyroid Hormone (Teriparatide) n=13 participants at risk Parathyroid hormone after double umbilical cord blood transplant.
General disorders Death	61.5% 8/13 • Number of events 8 • 2 years

Other adverse events

Other adverse events
Measure	Parathyroid Hormone (Teriparatide) n=13 participants at risk Parathyroid hormone after double umbilical cord blood transplant.
General disorders Death	61.5% 8/13 • Number of events 8 • 2 years

Additional Information

Adam Mendizabal, Statistician

The EMMES Corporation

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place