A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/17/2018 |
Start Date: | February 27, 2012 |
End Date: | July 11, 2016 |
A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL
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.
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.
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
We found this trial at
30
sites
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