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 range18 Years
SexALL
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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…
What they're measuring
1
Maximum tolerated dose of oral azacitidine (CC-486) (Phase I)