Trial Outcomes & Findings for Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer (NCT NCT00295880)

Results Overview

Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Daily through Day 60 post transplant

Results posted on

2017-12-28

Participant Flow

Patients are recruited from within the Department of Blood and Marrow Transplant Program. (Patients will be co-enrolled on study MT2005-10 (NCT00309842). Eligibility for this study are identical to MT2005-10.)

Participant milestones

Participant milestones
Measure	Umbilical Cord Blood Transplant Patients Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Umbilical Cord Blood Transplant Patients Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Overall Study IBMI unit could not be volume reduced	1
Overall Study Unit randomization did not occur	1

Baseline Characteristics

Donor Umbilical Cord Blood Transplant By Injection Into the Bone Marrow in Treating Patients With Hematologic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Umbilical Cord Blood Transplant Patients n=12 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Daily through Day 60 post transplant

Number of days to neutrophil recovery observed in recipients of two umbilical cord blood units (UCB)administered i.v. Neutrophil recovery is defined as first of 3 consecutive days with ANC (absolute neutrophil count) greater than or equal to 500/ul.

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=10 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Median Number of Days to Neutrophil Engraftment	21 Days Interval 17.0 to 49.0

SECONDARY outcome

Timeframe: 6 months

Population: Patients who completed treatment.

Number of patients with sustained neutrophil recovery with chimerism (evidence of engraftment of both cord blood transplants) at 6 months.

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=10 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Number of Patients Achieving Neutrophil Recovery	9 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 1 patient was not evaluable due to graft failure

Number of patients who received both cord blood units and achieved sustained donor engraftment

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=10 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Number of Patients With Evidence of Engraftment.	2 Participants

SECONDARY outcome

Timeframe: 100 days post transplant

Population: 2 patients were not graded for acute GVHD due to graft failure.

Number of patients who exhibited grade II-IV acute GVHD at 100 days post umbilical cord blood transplant.

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=8 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Number of Patients With Acute Graft-versus-host Disease (GVHD)	7 Participants

SECONDARY outcome

Timeframe: Day 100 and Day 180

Number of patients who were deceased at days 100 and 180 from any cause other than relapse.

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=10 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Number of Patients With Transplant-related Mortality (TRM)	5 Participants

SECONDARY outcome

Timeframe: Day 100 and 1 year

Overall survival of patients-Number of patients who were alive at Day 100 and 1 year post transplant.

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=10 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Number of Patients Surviving at Day 100 and 1 Year.	5 Participants

SECONDARY outcome

Timeframe: 100 days post transplant

Population: 2 patients were not yet graded for acute gvhd

Number of umbilical cord blood transplant patients developing severe GVHD at 100 days post transplant.

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=8 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD)	2 Participants

SECONDARY outcome

Timeframe: 1 year post transplant

Population: Only 7 patients were at risk for chronic GVHD

Number of umbilical cord blood transplant patients with limited and extensive chronic GVHD.

Outcome measures

Outcome measures
Measure	Umbilical Cord Blood Transplant Patients n=7 Participants Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Number of Patients With Chronic Graft-versus-host Disease (GVHD).	2 Participants

Adverse Events

Umbilical Cord Blood Transplant Patients

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Umbilical Cord Blood Transplant Patients n=12 participants at risk Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
Blood and lymphatic system disorders graft failure	8.3% 1/12 • Number of events 1
Blood and lymphatic system disorders Acute GVHD Grade 3	16.7% 2/12 • Number of events 2
General disorders Death	41.7% 5/12 • Number of events 5

Other adverse events

Adverse event data not reported

Additional Information

John E. Wagner, M.D.

Masonic Cancer Center, University of Minnesota Blood and Marrow Transplant Program

Phone: 612-626-2961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place