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New drug cocktail aims to stop rare blood cancer after transplant

NCT ID NCT07389616

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether combining two drugs, cidabenamine and azacitidine, can stop high-risk peripheral T-cell lymphoma from progressing after a stem cell transplant. About 40 adults aged 18 to 70 will receive the drug combo as maintenance therapy. The goal is to see if it improves survival and keeps the cancer from coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cidabenamine and azacitidine
What this could lead to
If this works, it could offer a way to keep high-risk peripheral T-cell lymphoma from coming back after a stem cell transplant, potentially improving survival.
What could go wrong
This is a small, early-phase trial with only 40 participants and no comparison group, so results may not be conclusive. The drugs may cause side effects or fail to prevent relapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 to 70 years, male or female. 2. Diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2022 WHO criteria, including pathological subtypes such as PTCL not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL), and angioimmunoblastic T-cell lymphoma (AITL), but excluding hepatosplenic T-cell lymphoma; and meeting at least one of the following high-risk criteria: ① Stable Disease (SD) at the time of transplantation; ② Relapse after autologous hematopoietic stem cell transplantation (any disease status); ③ ≥ Partial Response 1 (PR1). 3. Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL, with no restriction on donor type. 4. Presence of complete donor chimerism in the bone marrow (T-cell chimerism \>95%). 5. ECOG performance status of 0 or 1. 6. Hematological function meeting the following requirements: ① Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; ② Platelet count (PLT) ≥ 50 × 10⁹/L. 7. Patients must have the ability to understand and be willing to participate in the study and must provide signed informed consent. Exclusion Criteria: 1. Known hypersensitivity to hypomethylating agents or Cidabenamine. 2. Presence of grade II or higher active acute Graft-versus-Host Disease (GVHD). 3. Presence of moderate or more severe chronic GVHD. 4. Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months prior to screening), myocardial infarction (within 3 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] Class ≥ III), status post pacemaker implantation, severe arrhythmia requiring pharmacological treatment, hepatic, renal, or metabolic disease, or pulmonary hypertension. 5. Active, uncontrolled infection, evidenced by any of the following: infection-related hemodynamic instability, worsening or new-onset infectious symptoms/signs, radiologic evidence of a new infectious focus, or persistent fever without localizing symptoms/signs where infection cannot be ruled out. 6. Known HIV infection. 7. Active Hepatitis B (HBV) or active Hepatitis C (HCV) requiring antiviral therapy. 8. History of an autoimmune disease. 9. Pregnant or lactating women. 10. Concurrent participation in another interventional clinical trial and receiving other investigational drugs.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General hospital,Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

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