Trial Outcomes & Findings for Once Daily Targeted Intravenous (IV) Busulfex as Part of Reduced-toxicity Conditioning for Patients With Refractory Lymphomas Undergoing Allogeneic Transplantation (NCT NCT01203020)

Results Overview

Percentage of participants--1 year overall survival (OS) following transplantation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

1 year

Results posted on

2023-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Overall Study STARTED	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Age, Continuous	53.50 years n=22 Participants
Sex: Female, Male Female	11 Participants n=22 Participants
Sex: Female, Male Male	11 Participants n=22 Participants

PRIMARY outcome

Timeframe: 1 year

Percentage of participants--1 year overall survival (OS) following transplantation.

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Percentage of 1 Year Overall Survival (OS)	63.6 percentage of participants Interval 46.4 to 87.3

PRIMARY outcome

Timeframe: At 2nd year

Percentage of participants-- 2 Year Overall Survival (OS) post transplant

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Percentage of 2 Year Overall Survival (OS)	59.1 percentage of participants Interval 41.7 to 83.7

PRIMARY outcome

Timeframe: At 1 year

Percentage of 1-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine.

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Percentage of 1-year Progression Free Survival (PFS)	59.1 percentage of participants Interval 41.7 to 83.7

PRIMARY outcome

Timeframe: At 2 year

Percentage of 2-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine.

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Percentage of 2-year Progression Free Survival (PFS)	45.5 percentage of participants Interval 28.8 to 71.8

SECONDARY outcome

Timeframe: At 1 year

Percentage of participants Relapse Rates (RR) following transplantation at 1-year.

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Relapse Rate (RR) Following Transplantation at 1-year.	28.7 percentage of participants Interval 6.3 to 45.8

SECONDARY outcome

Timeframe: At 2 year

Percentage of participants Relapse Rates (RR) following transplantation at 2-year.

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Relapse Rate (RR) Following Transplantation at 2-year.	39.7 percentage of participants Interval 13.7 to 57.9

SECONDARY outcome

Timeframe: At 1 year

Percentage of participants NRM following RTC transplantation at 1-year.

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year.	17.1 percentage of participants Interval 0.0 to 33.1

SECONDARY outcome

Timeframe: At 2 years

Percentage of participants NRM following RTC transplantation at 2-year.

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years.	24.6 percentage of participants

SECONDARY outcome

Timeframe: Day 100

Count/Percentage rates of acute and chronic graft versus host disease (GVHD).

Outcome measures

Outcome measures
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 Participants Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
Rates of Acute and Chronic Graft Versus Host Disease (GVHD). Acute GVHD	5 Participants
Rates of Acute and Chronic Graft Versus Host Disease (GVHD). Chronic GVHD	3 Participants

Adverse Events

Allogeneic Hematopoietic Progenitor Cell Transplant

Serious events: 9 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Allogeneic Hematopoietic Progenitor Cell Transplant n=22 participants at risk Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant Busulfan: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 Fludarabine: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
General disorders Death	40.9% 9/22 • Number of events 9 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Abraham Kanate

WV Cancer Institute

Phone: 3049065228

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place