Trial Outcomes & Findings for Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma (NCT NCT00856245)

Results Overview

Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

up to 7 days

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Rituximab Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
Overall Study STARTED	19
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
Overall Study Was not transplanted	5

Baseline Characteristics

Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=19 Participants Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 7 days

Population: 21 patients were initially enrolled; 2 were withdrawn after signing informed consent per physician decision. Of the remaining 19: 5 did not have harvestable stem cells; 14 completed stem cell collection and PCR evaluation.

Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.

Outcome measures

Outcome measures
Measure	Rituximab n=14 Participants Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
Rate of PCR Negativity	14 Participants

SECONDARY outcome

Timeframe: up to 60 months

Population: Of the 14 patients that had harvestable cells, 3 chose to delay transplant. The remaining 11 patients underwent Autologous stem cell transplantation (Auto-SCT).

Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.

Outcome measures

Outcome measures
Measure	Rituximab n=11 Participants Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
Progression Free Survival (PFS) and Overall Survival (OS) PFS in FL	24 months Interval 9.0 to 60.0
Progression Free Survival (PFS) and Overall Survival (OS) OS in FL	36 months Interval 24.0 to 60.0
Progression Free Survival (PFS) and Overall Survival (OS) PFS in ML	36 months Interval 24.0 to 48.0
Progression Free Survival (PFS) and Overall Survival (OS) OS in ML	48 months Interval 24.0 to 60.0

Adverse Events

Rituximab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rituximab n=19 participants at risk Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	5.3% 1/19 • Number of events 1 • 1 year post-transplant or post-harvest

Additional Information

Siddhartha Ganguly, MD

University of Kansas Cancer Center

Phone: (913) 588-6030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place