NCT07388563Toboroz1. fázis
Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 20.
Rövid összefoglaló (regiszter, angolul)
Background: T-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses). Azacitidine and abatacept are 2 drugs that are used to treat other diseases. Researchers want to know if these drugs, used together, can help people with T-cell lymphoma. Objective: To learn if azacitidine combined with abatacept can shrink tumors in people with T-cell lymphoma. Eligibility: People aged 18 years and older with T-cell lymphoma that either came back or did not respond to treatment. Design: Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken. Azacitidine is injected under the skin of the thigh, abdomen, or upper arm. Abatacept is infused through a needle inserted into a vein in the arm. Participants will receive the study drugs in 28-day cycles for up to 13 cycles. They will come to the clinic for each treatment. They will come to the clinic on day 1 and day 15 of the first cycle. After that, they will come to the clinic on the first 5 or 7 days of each cycle. Each clinic visit will take no more than 8 hours. Imaging scans and other tests will be repeated during the study. Participants will have follow-up visits for up to 5 years after they stop taking the study drugs....
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2026. febr. 4.
- Kezdés
- 2026. márc. 26.
- Elsődleges befejezés
- 2027. márc. 31.
- Fő szponzor
- National Cancer Institute (NCI)
- Betegségek
- Akut limfoid leukémia (ALL)
- NCT-szám
- NCT07388563
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 20
- 2026. márc. 26. és az elsődleges befejezés (2027. márc. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation.
- Anti-cancer therapy within 2 weeks prior to the study treatment initiation. Note: systemic steroids are allowed if <= 100 mg/per day of prednisone (or equivalent) and were used for <= 7 days during 2 weeks before the study treatment initiation.
- Any investigational therapy within 2 weeks prior to the study treatment initiation.
- Active central nervous system involvement with lymphoma. Previously treated central nervous system involvement with lymphoma will be allowed if >3 months since end of treatment.
Más betegség
- Any second malignancy that requires current active systemic therapy.
- Latent tuberculosis (TB) infection.
- Known allergy or hypersensitivity to any of the study drugs.
- Uncontrolled intercurrent illness, factors, evaluated by medical history, electrocardiogram (EKG), and physical exam that would potentially increase in risk of participant.
Laborértékek
- Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.
A regiszterben nem jelölt feltételek
- -INCLUSION CRITERIA
- Participants must have a histologically or cytologically confirmed T-cell lymphoma confirmed by the Laboratory of Pathology (LP), NCI. The one of the following T-cell lymphomas are included:
- Peripheral T-cell lymphoma not otherwise specified (PTCL, NOS)
- Angioimmunoblastic T-cell lymphoma (AITL)
- T-follicular helper (TFH) lymphoma
- Anaplastic large cell lymphoma (ALCL)
- Enteropathy-associated T-cell lymphoma (EATL)
- Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)
- Adult T-cell leukemia/lymphoma (ATLL)
- Other T-cell lymphoma (TCL)
- Participants must have a disease that is relapsed or refractory after initial systemic treatment.
- Participants must have evaluable disease on screening imaging or by laboratory assessment.
- Age >= 18 years.
- ECOG performance status <= 2.
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) / >= 1,000 cells/mcL OR >= 500 cells/mcL if bone marrow involvement with lymphoma
- Platelets / >= 50,000 cells/mcL OR >= 25,000 cells/mcL if bone marrow involvement with lymphoma
- Hemoglobin / >= 8 g/dL (transfusions permitted)
- Renal function / Serum creatinine <= 2 mg/dL OR Glomerular filtration rate (GFR) >= 40 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD).
- Note: there is no limit if involved by lymphoma.
- If not on target, a 24-hour urine creatinine clearance can be used to directly measure creatinine clearance.
- Total bilirubin / <= 1.5 x upper limit of normal (ULN)
- Aspartate Aminotransferase (AST) / <= 3.0 x ULN
- Alanine Aminotransferase (ALT) / <= 3.0 x ULN
- Prothrombin time (PT) / <1.5 x ULN
- Activated partial thromboplastin time (aPTT) / <1.5 x ULN; < 5.0 x ULN if the aPTT is prolonged because of a positive Lupus Anticoagulant
- International normalized ratio (INR) / <1.5 x ULN
- Participants, seropositive for human immunodeficiency virus (HIV), must have an undetectable HIV viral load.
- Participants, seropositive for hepatitis C virus (HCV) infection, must have been treated and have an undetectable HCV viral load.
- Participants who are hepatitis B core antibody (HBcAb) positive must have a hepatitis B virus (HBV) viral load result <100 IU/mL. Note: participants who are hepatitis B surface antigen (HBsAg) positive are excluded.
- Participants with detectable Epstein-Barr virus (EBV) or Cytomegalovirus (CMV) by polymerase chain reaction will be eligible provided they do not have end organ dysfunction from EBV or CMV infection.
- Participants with pulmonary disease such as chronic obstructive pulmonary disease and non-infectious liver disease who otherwise meet the requirements.
- Women of child-bearing potential (WOCBP) must agree to use effective methods of contraception (barrier, hormonal, surgical sterilization, abstinence) during the study treatment and for 6 months after the completion of the study treatment. Note: WOCBP is defined as any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.
- Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) during the study treatment and for 3 months after the completion of the study treatment. These men must not freeze or donate sperm within the same period.
- Nursing participants must be willing to discontinue nursing from study treatment initiation through six (6) months after the last dose of the study drug(s).
- Ability of the participant to understand and the willingness to sign a written informed consent document.
Életkor a regiszterben: 18 év – 120 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institutes of Health Clinical Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Bethesda | Egyesült Államok | Toboroz |
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