Phase 2
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)
Diffuse Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01453205 ↗Enrolled (actual)
187
Serious AEs
46.0%
Results posted
Mar 2018
Primary outcome: Primary: Objective Response Rate (ORR) — 47.5; 46.2; 43.6 Percentage of participants — p=0.5543
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI-551 2 mg/kg (Drug); Rituximab (Drug); ICE (Drug); DHAP (Drug); Autologous Stem Cell Transplant (ASCT) (Procedure); MEDI-551 4 mg/kg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedImmune LLC
- Primary completion
- Jul 2016
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 | — |
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.
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.