Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
- Registration Number
- NCT03072771
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
Based on the further need to improve progression-free survival (PFS) and overall survival (OS) post autologous stem cell transplant (SCT) for DLBCL, the hematopoietic profile of patients following auto-SCT, the activity of blinatumomab in DLBCL and its favorable toxicity profile, the investigators propose a pilot study to test blinatumomab as consolidation t...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASCT + BEAM + Blinatumomab Autologous stem cell transplant * Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: * carmustine is typically given intravenously (IV) at a dose of 300 mg/m\^2 on Day -7 * etoposide is typically given IV at a dose of 100 mg/m\^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) * cytarabine is typically given IV at a dose of 100 mg/m\^2 BID on Days -6, -5, -4, and -3 (8 doses) * melphalan is typically given IV at a dose of 140 mg/m\*2 on Day -2 * Auto-SCT will take place on Day 0 as per institutional guidelines * Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks). ASCT + BEAM + Blinatumomab Peripheral blood draws * Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: * carmustine is typically given intravenously (IV) at a dose of 300 mg/m\^2 on Day -7 * etoposide is typically given IV at a dose of 100 mg/m\^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) * cytarabine is typically given IV at a dose of 100 mg/m\^2 BID on Days -6, -5, -4, and -3 (8 doses) * melphalan is typically given IV at a dose of 140 mg/m\*2 on Day -2 * Auto-SCT will take place on Day 0 as per institutional guidelines * Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks). ASCT + BEAM + Blinatumomab Blinatumomab * Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: * carmustine is typically given intravenously (IV) at a dose of 300 mg/m\^2 on Day -7 * etoposide is typically given IV at a dose of 100 mg/m\^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) * cytarabine is typically given IV at a dose of 100 mg/m\^2 BID on Days -6, -5, -4, and -3 (8 doses) * melphalan is typically given IV at a dose of 140 mg/m\*2 on Day -2 * Auto-SCT will take place on Day 0 as per institutional guidelines * Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks). ASCT + BEAM + Blinatumomab Carmustine * Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: * carmustine is typically given intravenously (IV) at a dose of 300 mg/m\^2 on Day -7 * etoposide is typically given IV at a dose of 100 mg/m\^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) * cytarabine is typically given IV at a dose of 100 mg/m\^2 BID on Days -6, -5, -4, and -3 (8 doses) * melphalan is typically given IV at a dose of 140 mg/m\*2 on Day -2 * Auto-SCT will take place on Day 0 as per institutional guidelines * Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks). ASCT + BEAM + Blinatumomab Cytarabine * Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: * carmustine is typically given intravenously (IV) at a dose of 300 mg/m\^2 on Day -7 * etoposide is typically given IV at a dose of 100 mg/m\^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) * cytarabine is typically given IV at a dose of 100 mg/m\^2 BID on Days -6, -5, -4, and -3 (8 doses) * melphalan is typically given IV at a dose of 140 mg/m\*2 on Day -2 * Auto-SCT will take place on Day 0 as per institutional guidelines * Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks). ASCT + BEAM + Blinatumomab Etoposide * Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: * carmustine is typically given intravenously (IV) at a dose of 300 mg/m\^2 on Day -7 * etoposide is typically given IV at a dose of 100 mg/m\^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) * cytarabine is typically given IV at a dose of 100 mg/m\^2 BID on Days -6, -5, -4, and -3 (8 doses) * melphalan is typically given IV at a dose of 140 mg/m\*2 on Day -2 * Auto-SCT will take place on Day 0 as per institutional guidelines * Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks). ASCT + BEAM + Blinatumomab Melphalan * Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: * carmustine is typically given intravenously (IV) at a dose of 300 mg/m\^2 on Day -7 * etoposide is typically given IV at a dose of 100 mg/m\^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) * cytarabine is typically given IV at a dose of 100 mg/m\^2 BID on Days -6, -5, -4, and -3 (8 doses) * melphalan is typically given IV at a dose of 140 mg/m\*2 on Day -2 * Auto-SCT will take place on Day 0 as per institutional guidelines * Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
- Primary Outcome Measures
Name Time Method Feasibility and tolerability of blinatumomab consolidation post auto-SCT as measured by percentage of patients who can finish a full course of blinatumomab post-auto-SCT Up to Day 70 -The primary endpoint is calculated by the proportion of patients who complete a full course of blinatumomab to the total number of patients started blinatumomab after auto-SCT.
- Secondary Outcome Measures
Name Time Method Complete remission rate in patients with residual disease after auto-SCT Up to Day 100 -Complete remission=disappearance of all evidence of disease
Overall survival 3 years post-auto-SCT -OS is defined as from the date of Day 0 to date of death. They are censored at the last follow-up otherwise.
Progression-free survival (PFS) 3 years post-auto-SCT -PFS is defined as from the date of Day 0 to date of progression or death, which occurs first. They are censored at the last follow-up otherwise.
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States