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Completed

NCT Number: NCT03072771

Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

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 therapy post auto-SCT for patients with DLBCL.

The investigators hypothesize the blinatumomab consolidation will optimize the effector to target (E-T) ratio and aid in the eradication of remaining tumor cells, leading to decreased relapse and increased overall survival. In addition, since tumor burden will be at a minimum, infusional toxicities including neurologic toxicities may also be limited. The purpose of this pilot study is to study the feasibility and tolerability of blinatumomab consolidation post auto-SCT for patients with chemo-sensitive DLBCL undergoing auto-SCT.

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Key information

Conditions

Diffuse Large B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Pre-ASCT Inclusion Criteria

  • At least 18 years of age
  • Histologically confirmed diagnosis of CD19 positive diffuse large B-cell lymphoma (DLBCL) or transformed large cell lymphoma from low grade lymphoma.
  • Chemo-sensitive (defined by complete remission (CR) or partial remission (PR) to most recent chemo regimen) based on pre-transplant positron emission tomography (PET) within 2 months of autologous transplant
  • Patients with bulky disease are eligible for study provided that the patient not undergo radiation therapy until 30 days after the end of blinatumomab administration.
  • Available representative tissue (from fresh or formalin fixed paraffin embedded tissue) from the most recent biopsy or archival tumor tissue for Clonotype evaluation for minimal residual disease (MRD) testing.

Pre-ASCT Exclusion Criteria

  • Chemo-resistant (defined by stable disease (SD) or progressive disease (PD) to most recent chemo regimen)
  • Pregnant or breastfeeding
  • Active central nervous system (CNS) involvement of Non-Hodgkin's Lymphoma (NHL)
  • Clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  • Prior stem cell transplant
  • Concurrent hematologic or non-hematologic malignancy requiring treatment
  • HIV seropositive, or active Hepatitis A, B, or C infection.
  • Uncontrolled congestive heart failure (CHF) or other comorbid systemic illnesses or severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.

Eligibility Criteria to Begin Consolidation Therapy

  • A participant must meet all of the following criteria on Day +42 visit in order to continue on the study to begin consolidation therapy with blinatumomab.
  • Performance status of Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky ≥ 60 %
  • Absence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke, sever brain injuries, dementia, or psychosis
  • Required clinical laboratory values:
  • Absolute neutrophil count (ANC) ≥ 1,000
  • Platelets ≥ 75,000
  • Hemoglobin ≥ 8 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless related to Gilbert's or Meulengracht's syndrome)
  • Alkaline phosphatase ≤ 5 x ULN
  • ALT and AST ≤ 5 x ULN
  • Calculated or measured creatinine clearance ≥ 50ml/min

Treatment and study plan

Blinatumomab

Drug

-Blinatumomab is a bispecific T cell engaging antibody

Other names: Blincyto

Autologous Stem Cell Transplant

Procedure

-Standard of care

Other names: ASCT, auto-SCT

carmustine

Drug

-Carmustine is an alkylating agent. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of carmustine.

Other names: BCNU, BiCNU®

etoposide

Drug

-Etoposide is a semi-synthetic podophyllotoxin derivative. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of etoposide.

Other names: VP16

Cytarabine

Drug

-Cytarabine, commonly known as Ara-C, is a synthetic nucleoside. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of cytarabine.

Other names: Ara-C, Cytosar-U ®, 1-β-Arabinofuranosylcytosine, Arabinosylcytosine, Cytosine arabinoside

melphalan

Drug

-Melphalan is an alkylating agent. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of melphalan.

Other names: Alkeran® Tablets, Phenylalanine mustard

Peripheral blood draws

Procedure

-Day +42, Day + 43, Day +56, and Day +100

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Progression-free survival (PFS)

    Time frame: 1 year 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.

  2. Progression-free survival (PFS)

    Time frame: 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.

  3. Overall survival

    Time frame: 1 year 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.

  4. Overall survival

    Time frame: 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.

  5. Complete remission rate in patients with residual disease after auto-SCT

    Time frame: Up to Day 100

    -Complete remission=disappearance of all evidence of disease

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Amgen

Registry information

Official study title

A Pilot Trial of Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With DLBCL

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Mar 7, 2017
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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