Trial Outcomes & Findings for A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies (NCT NCT02623439)

NCT ID: NCT02623439

Last Updated: 2025-11-10

Results Overview

180 days after transplantation

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Day 180
• Results posted on: 2025-11-10

Participant Flow

Participant milestones

Measure	cyclophosphamide post BMT Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	cyclophosphamide post BMT Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Overall Study Withdrawal by Subject	1
Overall Study Screen Failure	1

Baseline Characteristics

A Study of Haploidentical Bone Marrow Transplant for Patients With Hematologic Malignancies

Baseline characteristics by cohort

Measure	Cyclophosphamide Post BMT n=8 Participants Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 180

180 days after transplantation

Outcome measures

Measure	cyclophosphamide post BMT n=8 Participants Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Overall Survival	3 Participants

Adverse Events

cyclophosphamide post BMT

Serious events: 5 serious events

Other events: 8 other events

Deaths: 5 deaths

Serious adverse events

Measure	cyclophosphamide post BMT n=8 participants at risk Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Renal and urinary disorders Renal Failure	12.5% 1/8 • Number of events 1 • 1 year
Immune system disorders CMV	12.5% 1/8 • Number of events 2 • 1 year
Immune system disorders Adenovirus	12.5% 1/8 • Number of events 1 • 1 year
Immune system disorders Acute GVHD	12.5% 1/8 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Failure	12.5% 1/8 • Number of events 1 • 1 year

Other adverse events

Measure	cyclophosphamide post BMT n=8 participants at risk Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant: Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
Immune system disorders Human herpesvirus 6 (HHV-6)	12.5% 1/8 • Number of events 2 • 1 year
Infections and infestations Enterococcus Faecalis UTI	12.5% 1/8 • Number of events 1 • 1 year
Infections and infestations BC (+) Rothia mucilaginosa septicemia	12.5% 1/8 • Number of events 1 • 1 year
Immune system disorders CMV	12.5% 1/8 • Number of events 1 • 1 year
Immune system disorders acute GVHD	25.0% 2/8 • Number of events 3 • 1 year
Immune system disorders aspergillosis	12.5% 1/8 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders stenotrophomomas pneumonia	12.5% 1/8 • Number of events 2 • 1 year
Blood and lymphatic system disorders Cytokine storm	25.0% 2/8 • Number of events 2 • 1 year
Infections and infestations vancomycin-resistant enterococcus (VRE)	12.5% 1/8 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders pulmonary infiltrates	12.5% 1/8 • Number of events 1 • 1 year
Infections and infestations extended spectrum beta-lactamase (ESBL) E.Coli	12.5% 1/8 • Number of events 1 • 1 year
Infections and infestations Systemic inflammatory response syndrome (SIRS)	12.5% 1/8 • Number of events 1 • 1 year
Infections and infestations Clostridioides difficile or C-diff	25.0% 2/8 • Number of events 2 • 1 year
Immune system disorders CMV viremia	12.5% 1/8 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders respiratory failure	12.5% 1/8 • Number of events 1 • 1 year

Additional Information

Michelle Padilla

University of California, San Diego

Phone: (858) 822-5354

Email: CancerCTO@health.ucsd.edu

Results disclosure agreements

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