Trial Outcomes & Findings for Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease (NCT NCT01702961)

NCT ID: NCT01702961

Last Updated: 2018-12-19

Results Overview

Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 12 months post-transplant
• Results posted on: 2018-12-19

Participant Flow

Participant milestones

Measure	Rituxan+BEAM: Autologous Stem Cell Transplant Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0
Overall Study STARTED	75
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Measure	Rituxan+BEAM: Autologous Stem Cell Transplant Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0
Overall Study Additional treatment	3
Overall Study Progressive disease	5
Overall Study Relapse	20
Overall Study Death	6
Overall Study Lost to Follow-up	2
Overall Study Ongoing	11

Baseline Characteristics

Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease

Baseline characteristics by cohort

Measure	Rituxan+BEAM: Autologous Stem Cell Transplant n=75 Participants Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Disease at diagnosis Hodgkin's Disease	25 participants n=5 Participants
Disease at diagnosis Non-Hodgkin's Lymphoma	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-transplant

Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas

Outcome measures

Measure	BEAM + R: Autologous Stem Cell Transplant n=75 Participants Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0
Disease-free Survival All patients	76 percentage of participant Interval 65.0 to 84.0
Disease-free Survival Hodgkin's Disease	88 percentage of participant Interval 67.0 to 96.0
Disease-free Survival Non-Hodgkin's Lymphomas	70 percentage of participant Interval 55.0 to 81.0

SECONDARY outcome

Timeframe: 30 days post-transplant

Population: All of the participants enrolled in the study engrafted.

Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.

Outcome measures

Measure

BEAM + R: Autologous Stem Cell Transplant n=75 Participants Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0

Median Days to Neutrophil Engraftment

11 days Interval 9.0 to 23.0

SECONDARY outcome

Timeframe: 3 months post-transplant

Population: Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin's disease.

Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.

Outcome measures

Measure	BEAM + R: Autologous Stem Cell Transplant n=75 Participants Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0
Number of Participants With Overall Best Response Achieved After Transplantation Complete Remission (CR)	63 participants
Number of Participants With Overall Best Response Achieved After Transplantation Partial Remission (PR)	8 participants
Number of Participants With Overall Best Response Achieved After Transplantation Stable Disease (SD)	0 participants
Number of Participants With Overall Best Response Achieved After Transplantation Relapsed Disease or Progressive Disease (PD)	4 participants

Adverse Events

Rituxan+BEAM: Autologous Stem Cell Transplant

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure

Rituxan+BEAM: Autologous Stem Cell Transplant n=75 participants at risk Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0

Infections and infestations Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia

1.3% 1/75 • Number of events 1 • Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant. Only related adverse events were collected for this study.

Other adverse events

Measure	Rituxan+BEAM: Autologous Stem Cell Transplant n=75 participants at risk Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning. BEAM Conditioning. Melphalan: Given on Day -1 Melphalan is administered according to the current SOP. Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2 VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2 BCNU: BCNU 300 mg/m2 IV given on Day -6 Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28 Stem Cells: Stem cells given on Day 0
Cardiac disorders Cardiovascular/ General - Other	1.3% 1/75 • Number of events 1 • Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant. Only related adverse events were collected for this study.
Infections and infestations Infection without neutropenia	1.3% 1/75 • Number of events 1 • Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant. Only related adverse events were collected for this study.
General disorders Pain - Other	1.3% 1/75 • Number of events 1 • Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant. Only related adverse events were collected for this study.
Gastrointestinal disorders Stomatitis/pharyngitis (oral/pharyngeal mucositis)	1.3% 1/75 • Number of events 1 • Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant. Only related adverse events were collected for this study.

Additional Information

George Carrum, MD

Baylor College of Medicine

Email: GCarrum@houstonmethodist.org

Results disclosure agreements

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