Trial Outcomes & Findings for Rituximab in Pretreated Elderly or Unfit B-CLL Patients (NCT NCT01576588)
NCT ID: NCT01576588
Last Updated: 2019-12-27
Results Overview
Overall response rate (ORR) is defined according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2008) guidelines, as the proportion of patients achieving complete response (CR), CR with minimal residual disease (MRD) negativity (complete molecular remission), nodular partial remission (nPR) and partial response (PR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
3 months +/- 2 weeks after the last treatment cycle.
Results posted on
2019-12-27
Participant Flow
Participant milestones
| Measure |
R-HDMP
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab in Pretreated Elderly or Unfit B-CLL Patients
Baseline characteristics by cohort
| Measure |
R-HDMP
n=25 Participants
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months +/- 2 weeks after the last treatment cycle.Overall response rate (ORR) is defined according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2008) guidelines, as the proportion of patients achieving complete response (CR), CR with minimal residual disease (MRD) negativity (complete molecular remission), nodular partial remission (nPR) and partial response (PR).
Outcome measures
| Measure |
R-HDMP
n=25 Participants
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Overall Response Rate
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 12 monthsProgression free survival (PFS) will be defined as the interval from entry into the study to disease progression or death.
Outcome measures
| Measure |
R-HDMP
n=25 Participants
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Progression Free Survival
|
11 months
Interval 10.0 to 12.0
|
SECONDARY outcome
Timeframe: 6 months.Population: Patient, who experienced any AE - 23.
Adverse events NCI CTCAE, version 4.0. Hematological toxicity was evaluated according to IWCLL 2008 guidelines.
Outcome measures
| Measure |
R-HDMP
n=25 Participants
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Number of Participants With Adverse Events
|
23 Participants
|
SECONDARY outcome
Timeframe: from date of randomization until the date of death from any cause, assessed up to 100 monthsOverall survival (OS) will be defined as the interval from date of randomization until the date of death from any cause, assessed up to 100 months.
Outcome measures
| Measure |
R-HDMP
n=25 Participants
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Overall Survival
|
68 months
Interval 47.0 to 89.0
|
Adverse Events
R-HDMP
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
R-HDMP
n=25 participants at risk
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.0%
3/25 • Number of events 3
|
|
Cardiac disorders
Extrasystolia
|
4.0%
1/25 • Number of events 1
|
|
Social circumstances
Orfarin overdosage
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Diarea
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper pulmonary infection
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left femur cervical stress fracture
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Renal insufficiency
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
R-HDMP
n=25 participants at risk
Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
Rituximab: Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
Glucocorticoid: Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
|
|---|---|
|
Endocrine disorders
Hyperglycemia
|
8.0%
2/25 • Number of events 3
|
|
Cardiac disorders
Hypertention
|
16.0%
4/25 • Number of events 13
|
|
Blood and lymphatic system disorders
Anemia
|
8.0%
2/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Number of events 2
|
|
Cardiac disorders
Chest discomfort/pain
|
8.0%
2/25 • Number of events 2
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2
|
|
Infections and infestations
Fever
|
12.0%
3/25 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
60.0%
15/25 • Number of events 26
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
8.0%
2/25 • Number of events 3
|
|
Nervous system disorders
Insomnia
|
12.0%
3/25 • Number of events 3
|
|
Blood and lymphatic system disorders
Leg edema
|
8.0%
2/25 • Number of events 2
|
Additional Information
Regina Pileckyte, investigator
Vilnius University Hospital Santaros Klinikos
Phone: +370 5 2501384
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place