Phase 2
Completed N=159
A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Source: ClinicalTrials.gov NCT01466153 ↗Enrolled (actual)
159
Serious AEs
36.0%
Results posted
May 2017
Primary outcomePrimary: Objective Response Rate — 59.7; 52.8; 63.9 Percentage of Participants — p=0.4475
Summary
The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
59.7; 52.8; 63.9 | 0.4475 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs) |
58; 33; 57; 19; 16; 19 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs |
0; 2; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs |
1; 2; 1; 1; 0; 0 | — |
| SECONDARY Complete Response Rate |
6.5; 5.6; 11.5 | 0.3206 |
| SECONDARY Minimal Residual Disease Negative Complete Response (CR) Rate |
1.6; 5.6; 4.9 | 0.3130 |
| SECONDARY Time to Response |
2.1; 1.9; 2.1 | — |
| SECONDARY Time to Disease Progression (TTP) |
15.4; 15.0; 16.1 | 0.9527 |
| SECONDARY Progression Free Survival (PFS) |
14.8; 15.0; 16.1 | — |
| SECONDARY Overall Survival (OS) |
NA; NA; NA | — |
| SECONDARY Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA) |
4; 8 | — |
| SECONDARY Terminal Half Life (t1/2) of MEDI-551 |
17.2; 22.0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Adequate hematological function
Exclusion Criteria
- Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
- Exposure to bendamustine within the 180 days before study enrollment
- Prior autologous or allogeneic stem cell transplantation (SCT);
- Clinically significant abnormality on electrocardiogram (ECG) as determined by the treating physician or medical monitor;
- History of other invasive malignancy within 5 years except for localized/in situ carcinomas;
- Evidence of active infection, Confirmed current central nervous system involvement by leukemia or lymphoma;
Data sourced from ClinicalTrials.gov (NCT01466153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.