Trial Outcomes & Findings for Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma (NCT NCT00366275)

Results Overview

PFS is calculated according to the Kaplan-Meier estimator. The observation time of each subject is defined as the time from entry into the study until lymphoma progression or death as a result of any cause whichever occurs first. The 5-year PFS is the estimated cumulative probability of surviving at least 5 years without progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

every 3 months for the first year after autotransplant and every 6 months after the first year of follow up

Results posted on

2012-10-31

Participant Flow

Between January 2002 and September 2007, 64 patients with relapsed or refractory follicular lymphoma were enrolled in the trial

Participant milestones

Participant milestones
Measure	Immunochemotherapy, in Vivo Purging and Autotransplant 2-4 courses every 3 weeks with rituximab 375 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 2 and cyclophosphamide 400 mg/m\^2 on days 2-6. Courses were started if granulocytes \>1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m\^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m\^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM \[carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan\] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m\^2 on days +14 and +21 after autotransplant.
Overall Study STARTED	64
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immunochemotherapy, in Vivo Purging and Autotransplant n=64 Participants 2-4 courses every 3 weeks with rituximab 375 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 2 and cyclophosphamide 400 mg/m\^2 on days 2-6. Courses were started if granulocytes \>1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m\^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m\^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM \[carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan\] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m\^2 on days +14 and +21 after autotransplant.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	50 years n=93 Participants
Sex: Female, Male Female	29 Participants n=93 Participants
Sex: Female, Male Male	35 Participants n=93 Participants
Region of Enrollment Italy	64 participants n=93 Participants

PRIMARY outcome

Timeframe: every 3 months for the first year after autotransplant and every 6 months after the first year of follow up

PFS is calculated according to the Kaplan-Meier estimator. The observation time of each subject is defined as the time from entry into the study until lymphoma progression or death as a result of any cause whichever occurs first. The 5-year PFS is the estimated cumulative probability of surviving at least 5 years without progression.

Outcome measures

Outcome measures
Measure	Immunochemotherapy, in Vivo Purging and Autotransplant n=58 Participants 2-4 courses every 3 weeks with rituximab 375 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 2 and cyclophosphamide 400 mg/m\^2 on days 2-6. Courses were started if granulocytes \>1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m\^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m\^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM \[carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan\] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m\^2 on days +14 and +21 after autotransplant.
Progression-free Survival	59 percent chance of PFS at 5 years Interval 44.0 to 73.0

Adverse Events

Immunochemotherapy, in Vivo Purging and Autotransplant

Serious events: 2 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immunochemotherapy, in Vivo Purging and Autotransplant n=64 participants at risk 2-4 courses every 3 weeks with rituximab 375 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 2 and cyclophosphamide 400 mg/m\^2 on days 2-6. Courses were started if granulocytes \>1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m\^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m\^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM \[carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan\] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m\^2 on days +14 and +21 after autotransplant.
General disorders sepsis	1.6% 1/64 • Number of events 64
Vascular disorders Vasculitis	1.6% 1/64 • Number of events 64

Other adverse events

Other adverse events
Measure	Immunochemotherapy, in Vivo Purging and Autotransplant n=64 participants at risk 2-4 courses every 3 weeks with rituximab 375 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 2 and cyclophosphamide 400 mg/m\^2 on days 2-6. Courses were started if granulocytes \>1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m\^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m\^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM \[carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan\] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m\^2 on days +14 and +21 after autotransplant.
Blood and lymphatic system disorders Hematological toxicity grade 3-4	84.4% 54/64 • Number of events 64

Additional Information

Luca Arcaini MD

Division of Hematology, Fondazione IRCCS Policlinico San Matteo, University of Pavia

Phone: +390382501308

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place