Trial Outcomes & Findings for Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma (NCT NCT00867529)

Last Updated: 2018-01-02

Results Overview

Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

At 18 months

Results posted on

2018-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Rituximab Pre- and Post-transplant) Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	63
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 Participants Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: At 18 months

Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.

Outcome measures

Outcome measures
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 Participants Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Disease Relapse Rate	18 Participants

SECONDARY outcome

Timeframe: Through day +100 after transplant

Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Outcome measures

Outcome measures
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 Participants Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0	17 Participants

SECONDARY outcome

Timeframe: At 6 months and then every year thereafter, up to 18 months

Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant.

Outcome measures

Outcome measures
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 Participants Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Overall Survival and Progression-free Survival PFS - 6 Months	48 Participants
Overall Survival and Progression-free Survival PFS - 1 Year	39 Participants
Overall Survival and Progression-free Survival PFS - 1.5 Years	34 Participants
Overall Survival and Progression-free Survival OS - 6 Months	52 Participants
Overall Survival and Progression-free Survival OS - 1 Year	44 Participants
Overall Survival and Progression-free Survival OS - 1.5 Years	36 Participants

SECONDARY outcome

Timeframe: 18 Months

Number of patients experiencing graft rejection and/or graft failure

Outcome measures

Outcome measures
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 Participants Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Rate of Graft Rejection and Graft Failure Graft Rejection	1 Participants
Rate of Graft Rejection and Graft Failure Graft Failure	0 Participants

SECONDARY outcome

Timeframe: 18 Months

Median time from transplant to engraftment.

Outcome measures

Outcome measures
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 Participants Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Time to Engraftment	10 Days Interval 0.0 to 48.0

Adverse Events

Treatment (Rituximab Pre- and Post-transplant)

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 participants at risk Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders Multiple Pulmonary Emboli	1.6% 1/63 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Respiratory, thoracic and mediastinal disorders Suspected Pulmonary Embolism	1.6% 1/63 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Infections and infestations Death Due to Infection	3.2% 2/63 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Infections and infestations Sepsis and Tachycardia	1.6% 1/63 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Infections and infestations Sepsis, Respiratory Failure, Mental Status Change	1.6% 1/63 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

Other adverse events

Other adverse events
Measure	Treatment (Rituximab Pre- and Post-transplant) n=63 participants at risk Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders ARDS	4.8% 3/63 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Respiratory, thoracic and mediastinal disorders Diffuse Alveolar Hemorrhage	4.8% 3/63 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Respiratory, thoracic and mediastinal disorders Hypoxia	17.5% 11/63 • Number of events 12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Hepatobiliary disorders Elevated Bilirubin	6.3% 4/63 • Number of events 4 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Renal and urinary disorders Elevated Creatinine	7.9% 5/63 • Number of events 5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

Additional Information

David G Maloney, MD PhD

Fred Hutch

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place