Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Le… (NCT05141682) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Oral Azacitidine for the Treatment of Relapsed or Refractory T-cell Large Granular Lymphocytic Leukemia
United States11 participantsStarted 2022-06-29
Plain-language summary
This phase I/II trial studies the best dose, possible benefits and/or side effects of oral azacitidine in treating patients with T-cell large granular lymphocytic leukemia that has come back (relapsed) or has not responded to previous treatment (refractory). Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* Diagnosis of T-LGLL defined as: CD3+CD8+ cell population \> 650/mm\^3 and the presence of a clonal T-cell receptor (within 1 month of diagnosis). This also includes patients with rare T-LGLL variants include CD4+ T-LGLL, and gamma/delta T-LGLL which can be CD4- and CD8, though patients still must have an LGL cell population \>500 cells/mm3 and the presence of a clonal T-cell receptor within 1 month of diagnosis or relapse. Note: patients with myelodysplastic syndrome (MDS)-like T-LGLL may be included with principal investigator (PI) approval even if CD3+CD8+ cell population is \< 650/mm\^3, though +TCR is required. Natural-killer (NK) large granular lymphocytic leukemia (LGL) is also permitted, provided there is a clonal NK-cell population noted with \> 500 cells/mm\^3
* Failed at least one line of frontline therapy; off treatment for at least 14 days or 5 half-lives, whichever is longer
* Require Treatment for T-LGLL (One or more required)
* Symptomatic anemia with hemoglobin \< 10 g/dL
* Transfusion-dependent anemia
* Neutropenia with absolute neutrophil count (ANC) \< 500/mm\^3
* Neutropenia with ANC \< 1500/mm\^3 with recurrent infections
* Platelet count \>= 50 x 10\^9/L
* Serum creatinine =\< 2 x the upper limit of normal (ULN)
* Total bilirubin =\< 1.5 x ULN (patients with Gilbert's syndrome with a bilirubin \> 1.5 x ULN permitted)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 1.5 x ULN
* Eas…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is Phase 1/Phase 2, the Phase 1 part is still figuring out the safest dose of oral azacitidine — what does that mean for how much is known about safety in T-cell large granular lymphocytic leukemia specifically, and how would that affect my risk if I were to participate?
2This trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — are there any similar trials testing oral azacitidine or other hypomethylating agents for my condition that are still open?
3The Phase 2 part is measuring whether patients achieve a complete or partial response to oral azacitidine — based on what's been seen so far, or in related studies, do you have a sense of how likely a meaningful response would be for someone with my specific situation?
4Since this is a relapsed or refractory T-cell LGL leukemia trial, would you recommend I try any remaining standard treatments first, or do you think my disease has progressed to the point where an experimental approach like this would be worth pursuing?
5Oral azacitidine is taken by mouth rather than by IV infusion — what are the typical side effects I should know about, and how demanding would the treatment schedule likely be on my daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose of oral azacitidine (CC-486) (Phase I)