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This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab+BEAM followed by ASCT followed by Pembrolizumab maintenance for 1 year. | Experimental | Patients will receive Pembrolizumab before BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Patients will receive 200 mg Pembrolizumab on Day -28 and Day -6 by IV infusion. Pembrolizumab 200 mg IV will resume at day 30+ after ASCT every 3 weeks for 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Number of participants with progression free survival at 1 year post transplant. Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive. | Baseline to 1 year post-ASCT |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive. | Baseline to 2 years post-ASCT |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjal Desai | Contact | 612-625-5469 | desai171@umn.edu | |
| Roberta Nicklow | Contact | nickl004@umn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Autologous stem cell transplant | Procedure | On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines. |
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| Carmustine | Drug | Patient will receive a single dose of BCNU on day -6, dose of 300 mg/m2 by IV infusion. |
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| Etoposide | Drug | Etoposide will be given at dose 100 mg/m2 BID intravenously on days -5, - 4, -3, and -2. |
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| Cytarabine | Drug | Cytarabine will be given at dose 100 mg/m2 BID intravenously on days -5, -4, - 3, and -2. |
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| Melphalan | Drug | Melphalan will be given at dose of 140 mg/m2 intravenously on day -1 in a single 20 minute infusion; dose will be based on actual body weight but capped at 3.6 mg/kg as part of BEAM conditioning. |
|
Number of participants with progression free survival at 1 year post transplant.
Time from date of study enrollment to date of first documented progression, or death. Patients who do not progress or die at the time of analysis will be censored at their last known date alive.
| Baseline to 2 years post-ASCT |
| Non-relapse mortality (NRM) | Number of participants experiencing death without relapse. | Day 100 post-ASCT |
| Overall Survival (OS) | Time from date of study enrollment to date of death. Patients who do not die at the time of analysis will be censored at their last known date alive. | Baseline to 5 year post-ASCT |
| Complete Radiologic Response Rate | Participants experiencing complete radiologic response rate at day 28 post-ASCT. | Day 28 |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| 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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