Phase 2
Completed N=187
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Source: ClinicalTrials.gov NCT01453205 ↗Enrolled (actual)
187
Serious AEs
46.0%
Results posted
Mar 2018
Primary outcomePrimary: Objective Response Rate (ORR) — 47.5; 46.2; 43.6 Percentage of participants — p=0.5543
Summary
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
47.5; 46.2; 43.6 | 0.5543 |
| SECONDARY Progression-Free Survival (PFS) |
6.1; 6.6; 7.7 | 0.8567 |
| SECONDARY Event-Free Survival (EFS) |
4.7; 4.2; 5.9 | 0.7412 |
| SECONDARY Overall Survival (OS) |
NA; NA; 23.0 | 0.9996 |
| SECONDARY Time to Progression (TTP) |
4.9; 4.2; 5.9 | 0.1686 |
| SECONDARY Time to Response (TTR) |
1.7; 2.3; 2.3 | — |
| SECONDARY Duration of Response (DR) |
NA; 7.1; 7.9 | — |
| SECONDARY Number of Participants With Best Overall Response Assessed by Blinded Independent Central Review (BICR) |
20; 6; 12; 18; 18; 12 | — |
| SECONDARY Acceptable Dose of MEDI-551 |
4 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
78; 51; 52; 33; 25; 27 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Hematology/Coagulation Laboratory Results |
47; 32; 33; 16; 9; 12 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Chemistry Laboratory Results (Include Urinalysis) |
1; 0; 0; 3; 1; 1 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and ECG Abnormalities |
0; 0; 2; 1; 1; 2 | — |
| SECONDARY Number of Participants Who Developed Detectable MEDI-551 Anti-drug Antibodies (ADA) |
1; 0 | — |
| SECONDARY Mean Serum Concentration of MEDI-551 |
47.0; 83.8; 16.7; 33.1; 64.8; 116 | — |
| SECONDARY Half-life (T1/2) of MEDI-551 |
14.4; 16.5; 18.9; 20.2 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL & Grade III FL
- Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
- Eligible for ASCT
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of ≥ 12 weeks
- Adequate hematological function
Exclusion Criteria
- Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
- Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
- Prior autologous or allogeneic SCT
- New York Heart Association ≥ Class II congestive heart failure; Clinically significant abnormality on ECG
- History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
- Evidence of active infection
- Documented current central nervous system involvement by leukemia or lymphoma
Data sourced from ClinicalTrials.gov (NCT01453205). 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.