Trial Outcomes & Findings for A Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies (NCT NCT00402714)

NCT ID: NCT00402714

Last Updated: 2017-01-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Day +100 following allogeneic stem cell transplant
• Results posted on: 2017-01-18

Participant Flow

Participant milestones

Measure	ECP/Pent Extracorporeal photopheresis, pentostatin and total body irradiation extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions	Pent Pentostatin and total body irradiation Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions
Overall Study STARTED	3	11
Overall Study COMPLETED	3	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies

Baseline characteristics by cohort

Measure	1 ECP and Pent/TBI n=3 Participants Extracorporeal photopheresis, pentostatin and total body irradiation extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions	2 Pent/TBI n=11 Participants Pentostatin and total body irradiation Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Gender Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	11 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Day +100 following allogeneic stem cell transplant

Outcome measures

Measure	1 ECP and Pent/TBI n=3 Participants Extracorporeal photopheresis, pentostatin and total body irradiation extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions	2 Pent/TBI n=11 Participants Pentostatin and total body irradiation Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions
Incidence of Grade 2-4 Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation in Patients Randomized to Photopheresis vs. no Photopheresis	1 participants	8 participants

SECONDARY outcome

Timeframe: 2 years following stem cell transplant

Outcome measures

Measure	1 ECP and Pent/TBI n=3 Participants Extracorporeal photopheresis, pentostatin and total body irradiation extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions	2 Pent/TBI n=11 Participants Pentostatin and total body irradiation Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions
Overall Survival	2 participants	5 participants

Adverse Events

ECP/Pent

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Pent

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	ECP/Pent n=3 participants at risk Extracorporeal photopheresis, pentostatin and total body irradiation extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions	Pent n=11 participants at risk Pentostatin and total body irradiation Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions
Respiratory, thoracic and mediastinal disorders ards	33.3% 1/3 • Number of events 1	27.3% 3/11 • Number of events 3
Vascular disorders dvt	0.00% 0/3	27.3% 3/11 • Number of events 11

Other adverse events

Measure	ECP/Pent n=3 participants at risk Extracorporeal photopheresis, pentostatin and total body irradiation extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions	Pent n=11 participants at risk Pentostatin and total body irradiation Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions
Skin and subcutaneous tissue disorders skin infection	0.00% 0/3	9.1% 1/11 • Number of events 1

Additional Information

Francine Foss MD

Yale University School of Medicine

Phone: 2037375312

Email: francine.foss@yale.edu

Results disclosure agreements

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