Trial Outcomes & Findings for Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders (NCT NCT00587054)

NCT ID: NCT00587054

Last Updated: 2017-03-10

Results Overview

Calculate the median overall survival of transplant patients

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 129 participants
• Primary outcome timeframe: up to 6 years
• Results posted on: 2017-03-10

Participant Flow

Participant milestones

Measure	Transplant Patients Adult Patients (\>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
Overall Study STARTED	129
Overall Study COMPLETED	120
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Transplant Patients Adult Patients (\>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
Overall Study Patient not treated	9

Baseline Characteristics

Trial of Allogeneic Stem Cell Transplants From HLA Compatible, Related and Unrelated Donors After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine For Adult Patients With Lymphohematopoietic Disorders

Baseline characteristics by cohort

Measure	Transplant Patients n=129 Participants Adult Patients (\>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	127 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 years

Calculate the median overall survival of transplant patients

Outcome measures

Measure	Transplant Patients n=120 Participants Adult Patients (\>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
Overall Survival of Transplant Patients	727.5 Days Interval 12.0 to 2231.0

Adverse Events

Transplant Patients

Serious events: 13 serious events

Other events: 126 other events

Deaths: 0 deaths

Serious adverse events

Measure	Transplant Patients n=129 participants at risk Adult Patients (\>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
Respiratory, thoracic and mediastinal disorders Adult respiratory disorder	0.78% 1/129 • Number of events 1
Cardiac disorders Left ventricular failure	0.78% 1/129 • Number of events 1
General disorders Constitutional symptoms, other	3.1% 4/129 • Number of events 4
Blood and lymphatic system disorders Hemorrhage, other	0.78% 1/129 • Number of events 1
Musculoskeletal and connective tissue disorders Hypoxia	2.3% 3/129 • Number of events 3
Infections and infestations infection unknown absolut neutriphil counts	0.78% 1/129 • Number of events 1
Infections and infestations Infection without neutropenia	2.3% 3/129 • Number of events 3
Nervous system disorders Leukoencephalopathy	0.78% 1/129 • Number of events 1
Skin and subcutaneous tissue disorders Rash	0.78% 1/129 • Number of events 1
Renal and urinary disorders Renal failure	0.78% 1/129 • Number of events 1
Nervous system disorders Seizure	0.78% 1/129 • Number of events 2
Eye disorders Vision-double vision	0.78% 1/129 • Number of events 1

Other adverse events

Measure	Transplant Patients n=129 participants at risk Adult Patients (\>18 years) with Lymphohematopoietic Disorders will receive Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplants After a Myeloablative Preparative Regimen With Hyperfractionated TBI, Thiotepa and Fludarabine
Metabolism and nutrition disorders Alkaline phosphatase	17.8% 23/129 • Number of events 23
Metabolism and nutrition disorders Bilirubin	24.0% 31/129 • Number of events 31
Metabolism and nutrition disorders Creatinine	10.1% 13/129 • Number of events 13
Blood and lymphatic system disorders Hemoglobin (Hgb)	90.7% 117/129 • Number of events 117
Metabolism and nutrition disorders Hyperglycemia	45.0% 58/129 • Number of events 58
Metabolism and nutrition disorders Hyperkalemia	20.2% 26/129 • Number of events 26
Metabolism and nutrition disorders Hypocalcemia	27.1% 35/129 • Number of events 35
Metabolism and nutrition disorders Hypokalemia	46.5% 60/129 • Number of events 60
Metabolism and nutrition disorders Hyponatremia	27.1% 35/129 • Number of events 35
Metabolism and nutrition disorders Hypophosphatemia	37.2% 48/129 • Number of events 48
Blood and lymphatic system disorders Leukocytes	96.9% 125/129 • Number of events 125
Blood and lymphatic system disorders Lymphopenia	96.9% 125/129 • Number of events 125
Blood and lymphatic system disorders Neutrophils	95.3% 123/129 • Number of events 123
Blood and lymphatic system disorders Platelets	96.1% 124/129 • Number of events 124
Blood and lymphatic system disorders Prothrombin time (PT)	8.5% 11/129 • Number of events 11
Blood and lymphatic system disorders Partial thromboplastin time (PTT)	17.1% 22/129 • Number of events 22
Blood and lymphatic system disorders SGOT (AST)	21.7% 28/129 • Number of events 28
Blood and lymphatic system disorders SGPT (ALT)	32.6% 42/129 • Number of events 42

Additional Information

Dr. Ann Jakubowski

Memorial Sloan-Kettering Cancer Center

Phone: 212-639-5013

Email: jakubowa@mskcc.org

Results disclosure agreements

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