10 Participants Needed

Abatacept for Blood Cancers

SH
LH
Overseen ByLauren Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment approach for people with blood cancers. It uses a drug called abatacept, an immunosuppressant, along with other medications to prevent graft-versus-host disease (GVHD) after a stem cell transplant. The trial seeks adults with blood cancers who can provide a specific type of cord blood needed for the transplant. Researchers will closely monitor participants' responses to the treatment over 18 months. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new approach.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking any investigational medications (those not approved by the FDA), you should discuss this with the trial's principal investigator to determine your eligibility.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that abatacept, a medication for rheumatoid arthritis, has a safety record similar to a placebo regarding overall cancer risk. Some studies noted a slightly higher risk of certain cancers, such as lung cancer, but these results were not consistent across all studies. Generally, patients tolerate abatacept well. This is important because the treatment in this trial uses abatacept as part of a combination to prevent graft-versus-host disease (GVHD) after a stem cell transplant. While some risk exists, evidence suggests that abatacept is generally safe for people.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about using Abatacept for blood cancers because it offers a novel approach to preventing graft-versus-host disease (GVHD) after stem cell transplants. Unlike traditional treatments that primarily focus on suppressing the immune response with drugs like tacrolimus and mycophenolate mofetil, Abatacept works by specifically targeting and modulating T-cell activation, reducing the risk of GVHD more precisely. This targeted mechanism has the potential to improve transplant outcomes and reduce complications, making it a promising addition to existing therapies.

What evidence suggests that abatacept might be an effective treatment for blood cancers?

Research has shown that abatacept can improve survival rates for patients undergoing hematopoietic stem cell transplant (HCT). In this trial, participants will receive a regimen that includes abatacept combined with tacrolimus and mycophenolate mofetil following an omidubicel transplantation. One study found that abatacept makes the procedure safer and potentially more accessible for patients receiving transplants from donors who are not a perfect match (7 out of 8 matched unrelated donors). Abatacept also reduces the risk of graft-versus-host disease (GVHD), a common issue where the donor's cells attack the patient's body. This makes it a promising option for blood cancer patients undergoing stem cell transplants. Although abatacept is primarily used to treat rheumatoid arthritis, its benefits in transplant situations are becoming clearer.13678

Who Is on the Research Team?

SH

Sanghee Hong, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

Adults diagnosed with blood cancers who have a matching cord blood unit for omidubicel HCT. They must be in good enough health to undergo the procedure, with proper heart, kidney, and lung function, normal liver enzymes, and able to perform daily activities without assistance. Women of childbearing potential and men must use two forms of contraception or abstain from sex.

Inclusion Criteria

My heart pumps well enough (ejection fraction is 40% or more).
I agree to use two forms of birth control or abstain from sex as required.
My lung function tests are more than half the normal expected value.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning Chemotherapy

Participants undergo myeloablative conditioning chemotherapy of physician's choice prior to transplantation

2-3 weeks

Transplantation and GVHD Prophylaxis

Participants receive omidubicel hematopoietic stem cell transplantation followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) for GVHD prophylaxis

4 weeks
Visits on day -1, +5, +14, and +28 for abatacept administration

Follow-up

Participants are monitored for safety, GVHD, and hematologic recovery post-transplant

18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Abatacept
Trial Overview The trial is testing abatacept combined with tacrolimus and mycophenolate mofetil as a way to prevent graft-versus-host disease after transplanting stem cells from umbilical cord blood (omidubicel) in patients with hematologic malignancies.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) following omidubicel HCTExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Malignancies in the rheumatoid arthritis abatacept clinical ...Regarding specific types of cancers, the risk of breast cancer with abatacept may be reduced (summary SIR 0.42, 95% CI 0.18 to 1.00); however, women with RA ...
Safety Data | ORENCIA® (abatacept)Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer ...
Efficacy and safety of abatacept in patients with rheumatoid ...In our clinical practice, ABT was as effective and safe in patients with a history of malignancy as in those without.
Abatacept improves survival in 7/8 MMUD HCT | ResearchResearchers found that abatacept improves survival for patients undergoing 7/8 MMUD HCT, which could help expand HCT access.
Abatacept for GVHD prophylaxis can reduce racial disparities ...In the United States, Blacks and Hispanics are less likely than Whites to survive acute leukemias and other serious hematologic ...
Abatacept and the risk of malignancy: a meta-analysis across ...This study showed that abatacept use was associated with an increased risk of all cancers excluding NMSC (SIR 1.27; 95% CI 1.16–1.39) and accounted for 32.4% of ...
Malignancy outcomes in patients with rheumatoid arthritis ...This international, post-marketing observational safety study did not find any statistically significant increase in the risk of overall malignancies.
Safety outcomes in patients with rheumatoid arthritis treated ...Other observational studies also reported an increased risk of total malignancies [30] and skin cancers [7, 32] in patients with RA exposed to ...
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