Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse
Conditions
Keywords
Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Drug Therapy, Hematologic Diseases, Lymphoma, B-cell, Lymphoma, Large B-cell, Diffuse, Monomethyl auristatin E
Brief summary
This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups. The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin. The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.
Detailed description
In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects). The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.
Interventions
DRUGbrentuximab vedotin
1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
DRUGrituximab
375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
DRUGvincristine
1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
DRUGcyclophosphamide
750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
DRUGprednisone
100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
DRUGdoxorubicin
50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
Sponsors
Seagen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b * International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age * Stage IAX (bulk defined as single lymph node mass \>10 cm in diameter), IB-IV disease * Measurable disease of at least 1.5 cm * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL
Exclusion criteria
* Previous history of treated indolent lymphoma * History of another primary malignancy that has not been in remission for 3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission Rate | Up to 6 months | Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). |
| Incidence of Adverse Events | Up to 6 months | Number (count) of participants that experienced at least 1 adverse event. |
| Incidence of Laboratory Abnormalities | Up to 6 months | Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Up to 6 months | Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) |
| Progression-free Survival | Up to approximately 4 years | Median progression-free survival (in months) and observed minimum-maximum range. |
| Overall Survival | Up to approximately 4 years | Median overall survival (in months) and observed minimum-maximum range. |
Countries
Czechia, Italy, Poland, Spain, United States
Participant flow
Pre-assignment details
Two patients enrolled but did not receive treatment.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | 29 |
| Part 1: BV(1.8 mg/kg) + RCHOP Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | 22 |
| Part 2: BV(1.8 mg/kg) + RCHP Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | 11 |
| Part 3: BV(1.8 mg/kg) + RCHP Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone
brentuximab vedotin: 1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | 11 |
| Part 3: RCHOP Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone
rituximab: 375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
vincristine: 1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles | 12 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 | 0 | 1 | 2 |
| Overall Study | Progressive Disease | 1 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part 1: BV(1.2 mg/kg) + RCHOP | Part 1: BV(1.8 mg/kg) + RCHOP | Part 2: BV(1.8 mg/kg) + RCHP | Part 3: BV(1.8 mg/kg) + RCHP | Part 3: RCHOP | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 11 Participants | 4 Participants | 6 Participants | 6 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 7 Participants | 5 Participants | 6 Participants | 39 Participants |
| Age, Continuous | 70 years | 64 years | 59 years | 68 years | 65 years | 66 years |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 5 Participants | 4 Participants | 1 Participants | 4 Participants | 4 Participants | 18 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 16 Participants | 12 Participants | 4 Participants | 4 Participants | 3 Participants | 39 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 8 Participants | 6 Participants | 6 Participants | 3 Participants | 5 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 18 Participants | 8 Participants | 11 Participants | 11 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) White | 27 Participants | 17 Participants | 8 Participants | 10 Participants | 12 Participants | 74 Participants |
| Region of Enrollment Czechia | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Italy | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Poland | 0 participants | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| Region of Enrollment United States | 29 participants | 22 participants | 11 participants | 8 participants | 10 participants | 82 participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 4 Participants | 10 Participants | 6 Participants | 39 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 7 Participants | 1 Participants | 6 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 29 | 2 / 22 | 0 / 11 | 1 / 11 | 2 / 12 |
| other Total, other adverse events | 29 / 29 | 22 / 22 | 11 / 11 | 11 / 11 | 12 / 12 |
| serious Total, serious adverse events | 16 / 29 | 14 / 22 | 5 / 11 | 4 / 11 | 4 / 12 |
Outcome results
Primary
Complete Remission Rate
Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Complete Remission Rate | 20 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Complete Remission Rate | 16 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Complete Remission Rate | 9 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Complete Remission Rate | 6 Participants |
| Part 3: RCHOP | Complete Remission Rate | 8 Participants |
Primary
Incidence of Adverse Events
Number (count) of participants that experienced at least 1 adverse event.
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Adverse Events | 29 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Adverse Events | 22 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Adverse Events | 11 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Adverse Events | 11 Participants |
| Part 3: RCHOP | Incidence of Adverse Events | 12 Participants |
Primary
Incidence of Laboratory Abnormalities
Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Time frame: Up to 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Any Chemistry Test | 4 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Calcium (mg/dL) | 1 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Neutrophils (x10^3/uL) | 4 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Sodium (mEq/L) | 0 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Alanine Aminotransferase (IU/L) | 0 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Absolute Neutrophil Count (x10^3/uL) | 4 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Potassium (mEq)/L | 0 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Leukocytes (x10^3/uL) | 3 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Any Hematology Test | 10 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Lymphocytes (x10^3/uL) | 8 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Platelets (x10^3/uL) | 1 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Glucose (mg/dL) | 3 Participants |
| Part 1: BV(1.2 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Hemoglobin (x10^3/uL) | 0 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Calcium (mg/dL) | 1 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Lymphocytes (x10^3/uL) | 15 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Any Chemistry Test | 7 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Platelets (x10^3/uL) | 1 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Any Hematology Test | 16 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Sodium (mEq/L) | 2 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Absolute Neutrophil Count (x10^3/uL) | 4 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Alanine Aminotransferase (IU/L) | 0 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Hemoglobin (x10^3/uL) | 1 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Neutrophils (x10^3/uL) | 4 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Potassium (mEq)/L | 2 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Leukocytes (x10^3/uL) | 2 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Incidence of Laboratory Abnormalities | Glucose (mg/dL) | 5 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Platelets (x10^3/uL) | 0 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Any Hematology Test | 4 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Lymphocytes (x10^3/uL) | 3 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Absolute Neutrophil Count (x10^3/uL) | 1 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Neutrophils (x10^3/uL) | 1 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Leukocytes (x10^3/uL) | 1 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Hemoglobin (x10^3/uL) | 0 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Any Chemistry Test | 2 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Glucose (mg/dL) | 0 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Potassium (mEq)/L | 1 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Calcium (mg/dL) | 0 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Sodium (mEq/L) | 0 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Alanine Aminotransferase (IU/L) | 1 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Neutrophils (x10^3/uL) | 2 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Calcium (mg/dL) | 0 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Any Hematology Test | 6 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Potassium (mEq)/L | 1 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Lymphocytes (x10^3/uL) | 4 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Alanine Aminotransferase (IU/L) | 0 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Sodium (mEq/L) | 0 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Platelets (x10^3/uL) | 0 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Leukocytes (x10^3/uL) | 1 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Glucose (mg/dL) | 0 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Hemoglobin (x10^3/uL) | 1 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Absolute Neutrophil Count (x10^3/uL) | 2 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Incidence of Laboratory Abnormalities | Any Chemistry Test | 1 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Alanine Aminotransferase (IU/L) | 0 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Leukocytes (x10^3/uL) | 1 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Any Hematology Test | 4 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Glucose (mg/dL) | 1 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Neutrophils (x10^3/uL) | 0 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Potassium (mEq)/L | 2 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Absolute Neutrophil Count (x10^3/uL) | 0 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Any Chemistry Test | 3 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Calcium (mg/dL) | 0 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Lymphocytes (x10^3/uL) | 4 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Platelets (x10^3/uL) | 0 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Hemoglobin (x10^3/uL) | 0 Participants |
| Part 3: RCHOP | Incidence of Laboratory Abnormalities | Sodium (mEq/L) | 0 Participants |
Secondary
Objective Response Rate
Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Objective Response Rate | 23 Participants |
| Part 1: BV(1.8 mg/kg) + RCHOP | Objective Response Rate | 19 Participants |
| Part 2: BV(1.8 mg/kg) + RCHP | Objective Response Rate | 10 Participants |
| Part 3: BV(1.8 mg/kg) + RCHP | Objective Response Rate | 10 Participants |
| Part 3: RCHOP | Objective Response Rate | 9 Participants |
Secondary
Overall Survival
Median overall survival (in months) and observed minimum-maximum range.
Time frame: Up to approximately 4 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Overall Survival | NA Months |
| Part 1: BV(1.8 mg/kg) + RCHOP | Overall Survival | NA Months |
| Part 2: BV(1.8 mg/kg) + RCHP | Overall Survival | NA Months |
| Part 3: BV(1.8 mg/kg) + RCHP | Overall Survival | NA Months |
| Part 3: RCHOP | Overall Survival | NA Months |
Secondary
Progression-free Survival
Median progression-free survival (in months) and observed minimum-maximum range.
Time frame: Up to approximately 4 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: BV(1.2 mg/kg) + RCHOP | Progression-free Survival | NA Months |
| Part 1: BV(1.8 mg/kg) + RCHOP | Progression-free Survival | NA Months |
| Part 2: BV(1.8 mg/kg) + RCHP | Progression-free Survival | NA Months |
| Part 3: BV(1.8 mg/kg) + RCHP | Progression-free Survival | NA Months |
| Part 3: RCHOP | Progression-free Survival | NA Months |