Azacitidine + Abatacept for T-Cell Lymphoma

NC
MJ
Overseen ByMax J Gordon, M.D.
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 explores the potential of two drugs, azacitidine and abatacept, to treat T-cell lymphoma, a type of blood cancer affecting the immune system. Researchers aim to determine if combining these drugs can effectively shrink tumors in patients whose lymphoma has returned or did not respond to initial treatments. Participants receive these medications in cycles, with regular clinic visits and follow-up tests. Suitable candidates for this trial have T-cell lymphoma that hasn't responded to previous treatments or has recurred. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had anti-cancer therapy or investigational therapy within 2 weeks before starting the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that azacitidine is safe and well-tolerated in treatments for other conditions, with promising survival rates. Abatacept has also undergone safety testing in many patients with high-risk blood cancers. Although specific side effects were not mentioned, previous studies suggest it is generally well-tolerated.

While this trial is in an early stage, both azacitidine and abatacept have been used safely in other contexts. Participants should know that the safety of using these drugs together for T-cell lymphoma is still under investigation. However, existing data on each drug separately offers some reassurance about their potential safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of azacitidine and abatacept for T-cell lymphoma because it offers a new approach to treatment by targeting the immune system differently. Azacitidine is known for its ability to alter DNA methylation, potentially reversing abnormal gene expressions in cancer cells, while abatacept modulates the immune response by interfering with T-cell activation. This dual-action approach could provide a more effective treatment by directly impacting both the cancer cells and the body's immune system, offering hope for patients who may not respond well to existing chemotherapy and targeted therapies.

What evidence suggests that azacitidine combined with abatacept could be an effective treatment for T-cell lymphoma?

Research has shown that azacitidine may effectively treat T-cell lymphoma. In some studies, 50% of patients showed no signs of cancer after treatment, and 25% experienced significant tumor reduction. Abatacept, typically used for autoimmune diseases, helps control the immune system and might also manage cancer growth. This trial will explore the combination of azacitidine and abatacept, with participants receiving either escalating/de-escalating doses or the maximum tolerated dose. Early evidence suggests that combining azacitidine with abatacept may shrink tumors in people with T-cell lymphoma, offering a new option for those whose cancer has returned or hasn't responded to other treatments.13456

Who Is on the Research Team?

MJ

Max J Gordon, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for adults with T-cell lymphoma that has returned or hasn't responded to initial treatment. Eligible types include PTCL, AITL, TFH lymphoma, ALCL, EATL, MEITL, ATLL and other TCLs. Participants must have measurable disease via imaging or lab tests.

Inclusion Criteria

My diagnosis is T-follicular helper lymphoma.
My diagnosis is peripheral T-cell lymphoma, not otherwise specified.
I have been diagnosed with Angioimmunoblastic T-cell lymphoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive azacitidine and abatacept in 28-day cycles for up to 13 cycles

52 weeks
Clinic visits on Day 1 and Day 15 of Cycle 0, then Days 1-5 or 1-7 of each subsequent cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for years 1-2, every 6 months for years 3-4, once a year for year 5

What Are the Treatments Tested in This Trial?

Interventions

  • Abatacept
  • Azacitidine

Trial Overview

The study tests if azacitidine (injected under the skin) combined with abatacept (infused into a vein) can shrink tumors in T-cell lymphoma patients. Treatments are given in cycles of 28 days up to 13 times with clinic visits required for administration and monitoring.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment2 Interventions
Group II: Arm 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Azacitidine and Abatacept in Relapsed or Refractory T-Cell ...

Objective: To learn if azacitidine combined with abatacept can shrink tumors in people with T-cell lymphoma. Eligibility: People aged 18 years ...

Azacitidine + Abatacept for T-Cell Lymphoma

The study tests if azacitidine (injected under the skin) combined with abatacept (infused into a vein) can shrink tumors in T-cell lymphoma ...

Real-world experience of combined treatment with azacitidine ...

A phase 2 study of aza/romi in patients with PTCL demonstrated an overall response rate (ORR) and complete response rate (CRR) of 61% and 48%, respectively, ...

Adding Azacitidine to Standard Chemotherapy May Be ...

Researchers have found that azacitidine may be capable of increasing the effectiveness of chemotherapy and aiding nearly 90% of patients who had peripheral T- ...

Azacitidine in Peripheral T-Cell Lymphoma: Prime Time for ...

In all, 9 patients responded to treatment with azacitidine, with a complete response (CR) rate of 50% and a partial response rate of 25%. Of the responding ...

Abatacept in combination with post-transplant ...

We retrospectively reviewed the outcomes of 99 consecutive patients with high-risk hematological malignancies who received mobilized peripheral ...