What side effects are associated with this type of intervention?

Common treatments for Acute Leukemia, particularly those involving PTCy, sirolimus, and novel agents like VIC-1911, have several known side effects. PTCy can cause infections, neutropenia, and hemorrhagic cystitis. Sirolimus is associated with stomatitis, hyperlipidemia, thrombocytopenia, and increased risk of infections. Novel agents often present hematologic toxicities, gastrointestinal disturbances, and potential immunosuppressive effects.

What prior FDA approvals exist?

For the treatment of Acute Leukemia, the FDA has approved several drugs that involve mechanisms similar to those in the PTCy/sirolimus plus VIC-1911 trial. Sirolimus, an mTOR inhibitor, is approved for various conditions and has been studied in leukemia for its immunosuppressive properties. Venetoclax, a BCL-2 inhibitor, and ivosidenib, an IDH1 inhibitor, are approved for use in combination with hypomethylating agents like azacitidine or decitabine for the treatment of Acute Myeloid Leukemia (AML). These combinations aim to enhance the efficacy of treatment by targeting different pathways involved in leukemia cell survival and proliferation.

What other types of research exist?

Promising novel alternatives for Acute Leukemia patients include: 1) HMA (hypomethylating agents) plus venetoclax, which has shown improved outcomes compared to HMA monotherapy. 2) HMA plus ivosidenib, particularly for patients with IDH1 mutations. Both combinations have demonstrated efficacy and are considered beneficial for patients who are medically unfit for intensive induction therapy.

← Back to Search

Other

PTCy + Sirolimus/VIC-1911 for Acute Leukemia Post-transplant Care

Phase 1 & 2

Waitlist Available

Led By Sherman Holtan, MD

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of acute leukemia in complete remission, myelodysplasia with <5% blasts, myeloproliferative neoplasm/myelofibrosis with <5% marrow or circulating blasts, or chemosensitive Hodgkin or non-Hodgkin lymphoma

Age 18 years or older

Must not have

Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 60 days after the last treatment of VIC-1911 or sirolimus

HCT-CI > 4 or unable to receive myeloablative TBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of drugs to prevent complications after a stem cell transplant. It focuses on patients at risk of serious issues like GVHD and relapse. The drugs work together to protect the transplanted cells by suppressing the immune system. Cyclophosphamide combined with tacrolimus has been used to prevent GVHD after a stem cell transplant.

Who is the study for?

This trial is for adults over 18 with certain blood disorders or lymphoma, who are in remission or have low blast counts. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and can't have a high risk of transplant complications (HCT-CI > 4) or hypersensitivity to the drugs used.

What is being tested?

The study tests PTCy/sirolimus combined with VIC-1911 as a way to prevent graft-versus-host disease (GVHD) and relapse after stem cell transplantation from donors. It's an early phase trial where all participants receive the same treatment without comparison groups.

What are the potential side effects?

Potential side effects may include reactions related to immune suppression by sirolimus and VIC-1911 such as increased infection risk, possible liver issues indicated by restrictions on AST/ALT levels, and other risks typically associated with post-transplant medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My leukemia is in complete remission, or I have a low blast count in myelodysplasia/myelofibrosis, or my lymphoma responds well to chemotherapy.

Select...

I am 18 years old or older.

Select...

I am mostly able to carry out my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I agree to use birth control during and for 60 days after treatment.

Select...

I cannot undergo intense bone marrow radiation due to high risk.

Select...

I will start maintenance therapy before day 75 after my transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirm safety and obtain an estimate of long-term efficacy as measured by aGVHD assessed (Phase II)

Determine the optimal dose of VIC-1911 when given in combination with standard immunosuppressive therapy in adult patients undergoing myeloablative stem cell transplantation.

Relapsed assessment (Phase II)

Secondary study objectives

Analyze markers of mTOR and IL-2 activity cells

Compare Graft-Versus-Host Disease-Free (GRFS) to the standard PTCY plus tacrolimus/mycophenolate mofetil regimen from MT2015-29

Compare duration of initial transplant hospitalization to patients age 18+ who received treatment on MT2015-29

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PTCy/sirolimus plus VIC-1911Experimental Treatment1 Intervention

Patients enrolled and treated with PTCy/sirolimus plus VIC-1911

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Leukemia often target specific cellular mechanisms to control the disease. PTCy (post-transplant cyclophosphamide) eliminates alloreactive T cells to prevent graft-versus-host disease (GVHD) after transplantation. Sirolimus inhibits the mTOR pathway, reducing the proliferation of leukemic cells. VIC-1911, a novel agent, is being studied for its potential to target specific pathways involved in leukemia. These treatments are crucial for Acute Leukemia patients as they aim to control the disease by targeting the underlying cellular processes, improving patient outcomes and reducing complications.

Thrombotic microangiopathy (TMA) in adult patients with solid tumors: a challenging complication in the era of emerging anticancer therapies.The opposing roles of the mTOR signaling pathway in different phases of human umbilical cord blood-derived CD34+ cell erythropoiesis.Resolution of paraneoplastic immune thrombocytopenia following everolimus treatment for metastatic renal cell carcinoma.