New combo therapy aims to beat tough blood cancer
NCT ID NCT06712121
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether combining two drugs, venetoclax and decitabine, can help adults with T-cell acute lymphoblastic leukemia or lymphoma that has come back or not responded to treatment. The study will enroll 28 participants and measure how many achieve complete remission. The goal is to find a new option for this hard-to-treat cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax and decitabine
- What this could lead to
- If successful, this combination could offer a new treatment option for patients whose T-cell leukemia/lymphoma has not responded to standard therapy.
- What could go wrong
- This is a small, early-phase trial with only 28 participants, so results may not apply broadly. The drugs can cause serious side effects like low blood counts and infections.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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19 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Adults aged 19 years or older but less than 80 years * Eastern Cooperative Oncology Group Performance Score (ECOG PS) ≤ 2 * Confirmed diagnosis of T-cell lymphoblastic leukemia/lymphoma according to the 2016 World Health Organization criteria, with relapse or failure to achieve complete remission despite induction chemotherapy * Patients with peripheral blood leukocytes \<50,000/uL (reducing white blood cell count through hydroxyurea or leukapheresis prior to trial enrollment is allowed) * At the time of screening, a calculated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formulas, or creatinine ≤ 1.4, total bilirubin ≤ 3.0 mg/dL, and AST and ALT \< x5 upper limit of normal (ULN) (however, if bilirubin elevation is due to Gilbert\'s syndrome or liver enzyme elevation is due to infiltration of leukemia/lymphoma, enrollment may be allowed even if the above conditions are exceeded) * Individuals who agree to the following contraceptive measures for a period of 3 months during treatment and for 3 months after completion: Exclusion Criteria: * Individuals in complete remission with previous treatment, if relapse or resistance is not confirmed by bone marrow examination or imaging/tissue examination. * Individuals who previously received venetoclax + decitabine treatment for T-lymphoblastic leukemia/lymphoma (participants who received venetoclax + decitabine treatment for a different type of cancer \[e.g., acute myeloid leukemia\] and have elapsed more than 1 year since the last treatment are allowed). * Pregnant or breastfeeding individuals. * Individuals who received systemic anticancer chemotherapy or participated in a clinical trial treatment within the past 2 weeks. * Individuals with active leukemia involving the central nervous system. * Individuals with a cancer type other than T-lymphoblastic leukemia/lymphoma that requires current active treatment (participants with a cancer type that has already been cured or is in a slow-progressing state without treatment, as determined by surgery/radiation/chemotherapy, may participate under the consultation of the clinical trial investigator). * Individuals with active human immunodeficiency virus (HIV) infection, hepatitis B/hepatitis C infection (participants without evidence of viral particles through PCR testing may be enrolled with the consent of an infectious disease specialist or hepatologist). * Uncontrolled bleeding. * Uncontrolled infection (bacterial, fungal, viral). * Uncontrolled mental illness. * Individuals who do not understand the informed consent or have difficulty in adequate communication, making them inappropriate for participation in the clinical trial. * Cases where the investigator judges that patient evaluation may be hindered or participation in the clinical trial is not appropriate. * Individuals who have a negative attitude towards participating in the clinical trial or who are unwilling to comply with the treatment and specimen collection schedule specified in the study protocol.
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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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Seoul National University Bundang Hospital
NOT_YET_RECRUITINGSeongnam-si, 13620, South Korea
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Seoul National University Hospital
NOT_YET_RECRUITINGSeoul, 03080, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell showdown: which transplant best keeps T-Cell cancer at bay?
- New maintenance therapy shows promise in preventing T-Cell cancer relapse after transplant
- Engineered immune cells take on tough T-Cell cancers in new trial
- Engineered immune cells take aim at stubborn leukemia after transplant
- Engineered immune cells take on tough blood cancers in early trial
- Experimental combo aims to boost stem cell transplant for rare blood cancers