Trial Outcomes & Findings for Transplantation of Umbilical Cord Blood Following Chemotherapy for Blood Cancers (NCT NCT00539656)

NCT ID: NCT00539656

Last Updated: 2020-02-18

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2020-02-18

Participant Flow

Participant milestones

Measure	Single Arm Patients with a hematologic malignancy who are candidates for myeloablative allogeneic BMT but lack an available matched sibling or unrelated marrow donor are eligible for this study if they have two suitably matched cord blood products with an adequate (1 x 10e7 TNC/kg IBW) but suboptimal (\<5 x 10e7 TNC/kg IBW) cell dose. Eligible diagnoses include AML, MDS, ALL after failure of at least one regimen, mixed lineage leukemia, CML beyond first chronic phase, and lymphoma ineligible for autologous transplantation.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transplantation of Umbilical Cord Blood Following Chemotherapy for Blood Cancers

Baseline characteristics by cohort

Measure	Single Arm n=3 Participants Patients with a hematologic malignancy who are candidates for myeloablative allogeneic BMT but lack an available matched sibling or unrelated marrow donor are eligible for this study if they have two suitably matched cord blood products with an adequate (1 x 10e7 TNC/kg IBW) but suboptimal (\<5 x 10e7 TNC/kg IBW) cell dose. One cord blood unit is expanded beginning 14 days before graft infusion (6 or 7 days before the start of the preparative regimen). Patients receive a standard myeloablative preparative regimen. The expanded cord blood unit is infused on day 0 and the unmanipulated cord blood unit is expanded on day 1.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Measure	Receive Two Cord Blood Units n=3 Participants Ex vivo expansion of cord blood: Day 0: the expanded cell product will be infused to patient; Day +1: A second, unexpanded, cord blood product will be infused
Number of Participants With Toxicities Related to Infusion of Expanded Cord Blood Products	0 Participants

PRIMARY outcome

Timeframe: 21 days

Number of participants who reached 3 consecutive days with ANC > 500

Outcome measures

Measure	Receive Two Cord Blood Units n=3 Participants Ex vivo expansion of cord blood: Day 0: the expanded cell product will be infused to patient; Day +1: A second, unexpanded, cord blood product will be infused
Neutrophil Engraftment Within 21 Days Engrafted by day 21	1 Participants
Neutrophil Engraftment Within 21 Days Not engrafted by day 21	2 Participants

SECONDARY outcome

Timeframe: 100 days

Number of participants who died without relapse in less than 100 days.

Outcome measures

Measure	Receive Two Cord Blood Units n=3 Participants Ex vivo expansion of cord blood: Day 0: the expanded cell product will be infused to patient; Day +1: A second, unexpanded, cord blood product will be infused
Non-relapse Mortality	1 Participants

Adverse Events

Single Arm

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure

Single Arm n=3 participants at risk Patients with a hematologic malignancy who are candidates for myeloablative allogeneic BMT but lack an available matched sibling or unrelated marrow donor are eligible for this study if they have two suitably matched cord blood products with an adequate (1 x 10e7 TNC/kg IBW) but suboptimal (\<5 x 10e7 TNC/kg IBW) cell dose. One cord blood unit is expanded beginning 14 days before graft infusion (6 or 7 days before the start of the preparative regimen). Patients receive a standard myeloablative preparative regimen. The expanded cord blood unit is infused on day 0 and the unmanipulated cord blood unit is expanded on day 1.

Respiratory, thoracic and mediastinal disorders ARDS

33.3% 1/3 • Number of events 1 • up to 100 days Neutrophil count was followed based on regular lab assessments

Other adverse events

Measure

Single Arm n=3 participants at risk Patients with a hematologic malignancy who are candidates for myeloablative allogeneic BMT but lack an available matched sibling or unrelated marrow donor are eligible for this study if they have two suitably matched cord blood products with an adequate (1 x 10e7 TNC/kg IBW) but suboptimal (\<5 x 10e7 TNC/kg IBW) cell dose. One cord blood unit is expanded beginning 14 days before graft infusion (6 or 7 days before the start of the preparative regimen). Patients receive a standard myeloablative preparative regimen. The expanded cord blood unit is infused on day 0 and the unmanipulated cord blood unit is expanded on day 1.

Blood and lymphatic system disorders Neutropenia

100.0% 3/3 • up to 100 days Neutrophil count was followed based on regular lab assessments

Additional Information

Allen Chen, MD,PhD,MHS

Johns Hopkins University School of Medicine

Phone: 410-614-4434

Email: chenal@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place