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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Blood draws, Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will have a physical exam with blood tests."
  • "Participants will have follow-up visits for up to 5 years after they stop taking the study drugs...."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether azacitidine and abatacept together can shrink T-cell lymphoma, a blood cancer that affects immune cells. It is for adults whose cancer came back or did not respond to treatment.

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....

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with T-cell lymphoma confirmed by the study’s lab.
  • Have cancer that came back or did not respond after initial treatment that works throughout the body. The cancer must be checked by scans or lab tests.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Meet study limits for blood counts, kidney and liver function, and blood clotting. Some limits differ if lymphoma affects an organ or bone marrow.
  • If you have HIV, the virus must be too low to detect. Hepatitis C must have been treated and be too low to detect. Hepatitis B must meet study test limits. Epstein-Barr virus or CMV is allowed only without organ damage from the infection.
  • If you can become pregnant, use effective birth control during treatment and for 6 months after. If you can father a child, use birth control and do not freeze or donate sperm during treatment and for 3 months after.
  • If breastfeeding, stop during treatment and for 6 months after the last dose.
  • Be able to understand the study and agree to join in writing.

Who can't join

  • Another cancer that currently needs treatment that works throughout the body.
  • Inactive tuberculosis (TB), or a positive hepatitis B surface antigen test.
  • An active infection needing medicine within 1 day before study treatment starts.
  • Cancer treatment or an experimental treatment within 2 weeks before study treatment starts. Short courses of steroids within the study’s dose limits are allowed.
  • A known allergy to either study drug.
  • Pregnancy.
  • Active lymphoma in the brain or spinal cord. Prior lymphoma there is allowed if treatment ended more than 3 months ago.
  • An uncontrolled illness or other health factors that could make joining the study more risky.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

-INCLUSION CRITERIA 1. 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) 2. Participants must have a disease that is relapsed or refractory after initial systemic treatment. 3. Participants must have evaluable disease on screening imaging or by laboratory assessment. 4. Age \>= 18 years. 5. ECOG performance status \<= 2. 6. 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 7. Participants, seropositive for human immunodeficiency virus (HIV), must have an undetectable HIV viral load. 8. Participants, seropositive for hepatitis C virus (HCV) infection, must have been treated and have an undetectable HCV viral load. 9. 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. 10. 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. 11. Participants with pulmonary disease such as chronic obstructive pulmonary disease and non-infectious liver disease who otherwise meet the requirements. 12. 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. 13. 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). 14. Ability of the participant to understand and the willingness to sign a written informed consent document. Exclusion Criteria 1. Any second malignancy that requires current active systemic therapy. 2. Latent tuberculosis (TB) infection. 3. Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation. 4. 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. 5. Any investigational therapy within 2 weeks prior to the study treatment initiation. 6. Known allergy or hypersensitivity to any of the study drugs. 7. Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening. 8. 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. 9. Uncontrolled intercurrent illness, factors, evaluated by medical history, electrocardiogram (EKG), and physical exam that would potentially increase in risk of participant.

Study sites (1)

MD