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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASCT + BEAM + Blinatumomab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blinatumomab | Drug | -Blinatumomab is a bispecific T cell engaging antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | -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. | Up to Day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | -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. | 1 year post-auto-SCT |
| Progression-free survival (PFS) |
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Pre-ASCT Inclusion Criteria
Pre-ASCT Exclusion Criteria
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:
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| Name | Affiliation | Role |
|---|---|---|
| Armin Ghobadi, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37871306 | Derived | Ghobadi A, Foley NC, Cohen J, Rettig MP, Cashen AF, Gehrs L, Christ S, Street E, Wallace N, Ritchey J, Mehta-Shah N, Westervelt P, Fehniger TA, Kahl B, Bartlett NL, DiPersio JF. Blinatumomab consolidation post-autologous stem cell transplantation in patients with diffuse large B-cell lymphoma. Blood Adv. 2024 Feb 13;8(3):513-522. doi: 10.1182/bloodadvances.2023011130. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Autologous stem cell transplant | Procedure | -Standard of care |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Peripheral blood draws | Procedure | -Day +42, Day + 43, Day +56, and Day +100 |
|
-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 years post-auto-SCT |
| Overall survival | -OS is defined as from the date of Day 0 to date of death. They are censored at the last follow-up otherwise. | 1 year post-auto-SCT |
| Overall survival | -OS is defined as from the date of Day 0 to date of death. They are censored at the last follow-up otherwise. | 3 years post-auto-SCT |
| Complete remission rate in patients with residual disease after auto-SCT | -Complete remission=disappearance of all evidence of disease | Up to Day 100 |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C510808 | blinatumomab |
| D002330 | Carmustine |
| D005047 | Etoposide |
| D003561 | Cytarabine |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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