Trial Outcomes & Findings for Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma (NCT NCT01661881)
NCT ID: NCT01661881
Last Updated: 2025-04-15
Results Overview
The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.
Results posted on
2025-04-15
Participant Flow
Patients enrolled from August 2012 through March 2014.
Participant milestones
| Measure |
RB/RC
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity.
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|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
RB/RC
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity.
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|---|---|
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Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
RB/RC
n=23 Participants
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity.
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|---|---|
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Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
|
MIPI at Diagnosis
Low
|
16 Participants
n=5 Participants
|
|
MIPI at Diagnosis
Intermediate
|
5 Participants
n=5 Participants
|
|
MIPI at Diagnosis
High
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.Population: The analysis dataset is comprised of all enrolled patients.
The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.
Outcome measures
| Measure |
RB/RC
n=23 Participants
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
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|---|---|
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Complete Remission (CR) Rate After 6 Cycles
|
.96 proportion of participants
Interval 0.81 to 1.0
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SECONDARY outcome
Timeframe: Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months.Population: The analysis dataset is comprised of all enrolled patients.
1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).
Outcome measures
| Measure |
RB/RC
n=23 Participants
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
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|---|---|
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1 Year Progression-Free Survival
|
.96 probability
Interval 0.73 to 0.99
|
SECONDARY outcome
Timeframe: All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction.ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)
Outcome measures
| Measure |
RB/RC
n=23 Participants
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
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|---|---|
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Autologous Stem Cell Transplant (ASCT) Rate
|
.91 proportion of participants
Interval 0.75 to 0.98
|
Adverse Events
RB/RC
Serious events: 15 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RB/RC
n=23 participants at risk
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity.
Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
13.0%
3/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.4%
4/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Sepsis
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infections and infestations - Other
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Lymphocyte count decreased
|
47.8%
11/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
34.8%
8/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelet count decreased
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
13.0%
3/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
Other adverse events
| Measure |
RB/RC
n=23 participants at risk
Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:
1. 2 g/m2 for age \>60 years old, creatinine 114.9-176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;
2. 1.5 g/m2 for age \>60 years old AND creatinine 114.9-176.8 lmol/l, or for age \>60 years old AND pre-existing neurotoxicity;
3. 1 g/m2 for age \> 60 years old AND creatinine 114.9-176.8 lmol/l AND pre-existing neurotoxicity.
Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
52.2%
12/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Eye disorders
Eye disorders - Other
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Esophageal pain
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Nausea
|
30.4%
7/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Edema limbs
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fatigue
|
82.6%
19/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Fever
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Infusion related reaction
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Irritability
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
Pain
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
General disorders
General disorders and administration site conditions - Other
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Immune system disorders
Immune system disorders - Other
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Mucosal infection
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Infections and infestations
Infections and infestations - Other
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Neutrophil count decreased
|
26.1%
6/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Platelet count decreased
|
43.5%
10/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
White blood cell decreased
|
13.0%
3/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Investigations
Investigations - Other
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Nervous system disorders
Headache
|
17.4%
4/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Psychiatric disorders
Insomnia
|
13.0%
3/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
2/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.7%
5/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
17.4%
4/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Hypotension
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
|
Vascular disorders
Phlebitis
|
4.3%
1/23 • Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment, ie approximately 26 weeks. All patients received 6 cycles of therapy with protocol cycle duration of 28 days.
Maximum grade toxicity by type was first calculated including only events with treatment-attribution of possible, probable or definite. Serious AEs and Other AEs were defined as treatment-related grade 3-5 events and grade 1-2 events, respectively, per CTCAEv4. No further data is available to specify classification of other beyond the general term.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place