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New treatment option for Lymphoma
Official title A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
ClinicalTrials.gov ID: NCT06915246
What this study is testing
What is VI-0609?
VI-0609 is an investigational medicine, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months;
- Karnofsky performance status ≥ 70%;
- Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;
- Candidate for AHCT consolidation therapy as assessed by their treating physician;
- Achieved a complete or partial response;
You likely can't join if
- Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation;
- Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records;
- Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy;
- Myelodysplasia or any active malignancy other than HL or NHL, or \< 5 years remission from any other prior malignancy;
- Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;
- Persistent marrow involvement (\>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;
See the full eligibility criteria
- Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months;
- Karnofsky performance status ≥ 70%;
- Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;
- Candidate for AHCT consolidation therapy as assessed by their treating physician;
- Achieved a complete or partial response;
- Completed collection of at least 2.0 x 10\^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPCs) by apheresis;
- Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2;
- Clinical laboratory and organ function criteria meeting study ranges/limits LVEF ≥ 50%; FEV1 \> 65% of predicted measurement, DLCO ≥ 50% of predicted;
- Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis
- Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation;
- Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records;
- Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy;
- Myelodysplasia or any active malignancy other than HL or NHL, or \< 5 years remission from any other prior malignancy;
- Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;
- Persistent marrow involvement (\>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;
- Not having sufficient bone marrow harvest to reach adequate cell dose for transplant;
- Active hepatitis B or C viral infection or HBsAg positive;
- Positive HIV antibody;
The study team makes the final eligibility decision.
Where it's taking place
- Goodyear, Arizona, United States
- Duarte, California, United States
- Newnan, Georgia, United States
- Zion, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goodyear, Arizona, United States; Duarte, California, United States; Newnan, Georgia, United States; Zion, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.