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A drug, carmustine (VI-0609), in combination with ethanol or propylene glycol, to treat lymphoma before autologous (your own cells) blood or marrow transplant (BMT)

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18 and older

Phase 2

4 Locations

NCT06915246

Clinical Trial Goal


To find out if carmustine, either with ethanol or propylene glycol, is safe and works well to treat lymphoma before autologous BMT

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have Hodgkin lymphoma or Non-Hodgkin lymphoma (NHL)
  • Have not had an allogeneic (cells from a donor) BMT 
  • Have not had an autologous BMT with high-intensity chemotherapy (chemo)
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Carmustine is a chemotherapy (chemo) drug that blocks the growth of cancer cells. 
Ethanol is sometimes used in chemo treatments. It can be used to block blood flow to tumors and potentially destroy them.
Propylene glycol is sometimes used in chemo treatments as a solubilizer. It can be used to dissolve drugs that are not readily soluble in water, making them easier to administer. 

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
  • Group 1 – Carmustine plus ethanol
  • Group 2 – Carmustine plus propylene glycol

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
 
You’ll get:
  • Carmustine – The dose you'll get depends on when you start the trial and how safe it has been
  • Ethanol –  Group 1 only - The dose you'll get depends on when you start the trial and how safe it has been
  • Propylene glycol –  Group 2 only - The dose you'll get depends on when you start the trial and how safe it has been

You'll have scans to see how well the treatment is working.

The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat lymphoma is new and unproven. 

Contacts


VIVUS Clinical, +1-888-998-4887, clinical@vivus.com

Locations


City of Hope PhoenixRECRUITING

Goodyear, Arizona
Anna Keryan, 626-218-1124, akeryan@coh.org

City of Hope National Medical CenterRECRUITING

Duarte, California
Anna Keryan, 626-218-1124, akeryan@coh.org

City of Hope AtlantaRECRUITING

Newnan, Georgia
Anna Keryan, 626-218-1124, akeryan@coh.org

City of Hope ChicagoRECRUITING

Zion, Illinois
Anna Keryan, 626-218-1124, akeryan@coh.org

ClinicalTrials.gov record


NCT06915246. First posted on Apr 8

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