Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Collaborator:
Genmab
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00802737
First received: December 4, 2008
Last updated: November 8, 2012
Last verified: November 2012
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Results First Received: May 17, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Leukaemia, Lymphocytic, Chronic |
| Intervention: |
Drug: Ofatumumab |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 2000 mg Ofatumumab + DR | Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months. These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. |
| 2000 mg Ofatumumab + BFR | Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months. These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. |
| 2000 mg Ofatumumab + Other | Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months. These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. |
Participant Flow: Overall Study
| 2000 mg Ofatumumab + DR | 2000 mg Ofatumumab + BFR | 2000 mg Ofatumumab + Other | |
|---|---|---|---|
| STARTED | 17 | 11 | 1 |
| Ongoing | 4 | 2 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 17 | 11 | 1 |
| Withdrawn due to Disease Progression | 7 | 2 | 0 |
| Death | 6 | 5 | 1 |
| Participant Too Unwell | 0 | 2 | 0 |
| Ongoing | 4 | 2 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 2000 mg Ofatumumab + DR | Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months. These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. |
| 2000 mg Ofatumumab + BFR | Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months. These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. |
| 2000 mg Ofatumumab + Other | Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months. These participants were classified as "other," defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. |
| Total | Total of all reporting groups |
Baseline Measures
| 2000 mg Ofatumumab + DR | 2000 mg Ofatumumab + BFR | 2000 mg Ofatumumab + Other | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
17 | 11 | 1 | 29 |
|
Age
[units: Years] Mean ± Standard Deviation |
64.8 ± 5.83 | 66.9 ± 9.08 | 84.0 ± NA [1] | 66.3 ± 7.85 |
|
Gender
[units: Participants] |
||||
| Female | 4 | 4 | 1 | 9 |
| Male | 13 | 7 | 0 | 20 |
|
Race/Ethnicity, Customized
[units: participants] |
||||
| Asian | 1 | 0 | 0 | 1 |
| White | 16 | 11 | 1 | 28 |
| [1] | A standard deviation of the mean was not calculated for one participant. |
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Outcome Measures
| 1. Primary: | Number of Participants (Par.) Classified as Responders (Rs) and Non-responders (NRs) for Objective Response in Accordance With the National Cancer Institute Working Group (NCIWG) 1996 Guidelines [ Time Frame: Start of treatment (Week 0/Visit 2) until Week 52 ] |
| 2. Secondary: | Duration of Response [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 52 ] |
| 3. Secondary: | Progression-Free Survival (PFS) [ Time Frame: Start of treatment (Week 0 of Visit 2) until Week 52 ] |
| 4. Secondary: | Time to Next Chronic Lymphocytic Leukemia (CLL) Treatment [ Time Frame: Time from start of study treatment (Week 0 of Visit 2) until the time of first administration of a CLL treatment other than ofatumumab (assessed for a mean of 11.4 months) ] |
| 5. Secondary: | Overall Survival (OS) [ Time Frame: Time from start of study treatment (Week 0 of Visit 2) until date of death or time that participant was no longer followed (median of 18.0 months) ] |
| 6. Secondary: | Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Week 24 [ Time Frame: Baseline (Visit 2) and Week 24 ] |
| 7. Secondary: | Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Week 52 [ Time Frame: Baseline (Visit 2) and Week 52 ] |
| 8. Secondary: | Median Percent Change of Tumor Size (Sum of Products Dimensions [SPD]) From Baseline (Visit 2) at Week 104 [ Time Frame: Baseline (Visit 2) and Week 104 ] |
| 9. Secondary: | Number of Participants With Negative and Positive Human Anti-human Antibody (HAHA) Results at the Time of the Last Visit (up to Month 26) [ Time Frame: Time of last visit (up to Month 26) ] |
| 10. Secondary: | Number of Participants Who Experienced Any Adverse Event [ Time Frame: From the first infusion (Visit 2/Week 0) up to Visit 34 (Month 3 of follow-up [up to Month 26]) or time of withdrawal (treatment and follow-up) ] |
| 11. Secondary: | Number of Participants With the Indicated Major Infections [ Time Frame: From the first infusion (Visit 2/Week 0) up to Visit 34 (Month 3 of follow-up [up to Month 26]) or time of withdrawal (treatment and follow-up) ] |
| 12. Secondary: | Number of Participants With Infections Requiring Hospitalization or Intravenous Antibiotics [ Time Frame: From the first infusion (Visit 2/Week 0) up to Visit 34 (Month 3 of follow-up [up to Month 26]) or time of withdrawal (treatment and follow-up) ] |
| 13. Secondary: | Cmax and Ctrough at Dose 1 (Visit 2, Week 0), Dose 5 (Visit 6, Week 4), and at Every Second Dose From Dose 10 (Visit 12, Month 4) Through Dose 32 (Visit 34, Month 26) [ Time Frame: Visit 2 (Week 0), Visit 6 (Week 4); every second visit starting at Visit 12 (Month 4) until Visit 34 (Month 26). In all visits, two samples for PK were collected, one prior to start of infusion and one at the end of infusion. ] |
Results not yet posted. Anticipated Posting Date:
07/2012
Safety Issue:
No