CompletedPhase 2

Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

United States15 participantsStarted 2016-12-12

Plain-language summary

The investigators propose to use Belinostat in combination with AZT as consolidation therapy for the treatment of ATLL.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically or cytologically documented adult T-cell leukemia/lymphoma (ATLL) with the following characteristics:
✓. One of the following:
✓. Presence of ATLL based on morphology, histology, flow cytometry, or T-cell clonality in peripheral blood during screening period prior enrollment.
✓. Documented Human T-cell lymphotropic virus type 1 (HTLV-1) infection: Documentation may be serologic assay (ELISA) confirmed by Western blot or polymerase chain reaction (PCR).
✓. Measurable or evaluable disease, including presence of ATLL by immunophenotyping from either histology or flow cytometry studies, or molecular disease as evidence by T-cell clonality detected by gene rearrangement studies.
✓. 18 years of age or older.
✓. Karnofsky performance status (KPS) ≥ 50% or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
✓. Patients must have adequate end organ and bone marrow function as defined below:

✕. Patients with progressive disease (after previous chemotherapy or AZT/IFNα) at the time of enrollment.
✕. Patients with chronic leukemia with favorable features, or smoldering type ATLL.
✕. Patients receiving any other investigational agents within 14 days prior to initiation of study therapy. (Exception: Patients actively receiving IFN-alfa-2b, PEG-IFN-alfa-2b, or similar forms of IFN-alfa are permitted).
✕. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that are likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
✕. Pregnant or breast-feeding women.
✕. Known hypersensitivity to histone deacetylases (HDACs), zidovudine, belinostat or any component of the formulation(s).
✕. Acute hepatitis or decompensated liver disease unless due to lymphoma. Chronic hepatitis will be required to be on prophylactic treatment during the study if provided liver function test meet criteria listed above without evidence of cirrhosis to be eligible.
✕. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix, non-metastatic, non-melanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy.

Number of Participants Achieving Complete Molecular Response in Blood Compartment (CMR)

Timeframe: From end of cycle 3 until at least end of month 12

Number of Participants Experiencing Treatment-Related Serious Adverse Events and Adverse Events

Timeframe: Up to 13 months

NCT IDNCT02737046

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Results submitted2025-12-31

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically or cytologically documented adult T-cell leukemia/lymphoma (ATLL) with the following characteristics:
✓. One of the following:
✓. Presence of ATLL based on morphology, histology, flow cytometry, or T-cell clonality in peripheral blood during screening period prior enrollment.
✓. Documented Human T-cell lymphotropic virus type 1 (HTLV-1) infection: Documentation may be serologic assay (ELISA) confirmed by Western blot or polymerase chain reaction (PCR).
✓. Measurable or evaluable disease, including presence of ATLL by immunophenotyping from either histology or flow cytometry studies, or molecular disease as evidence by T-cell clonality detected by gene rearrangement studies.
✓. 18 years of age or older.
✓. Karnofsky performance status (KPS) ≥ 50% or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
✓. Patients must have adequate end organ and bone marrow function as defined below:

✕. Patients with progressive disease (after previous chemotherapy or AZT/IFNα) at the time of enrollment.
✕. Patients with chronic leukemia with favorable features, or smoldering type ATLL.
✕. Patients receiving any other investigational agents within 14 days prior to initiation of study therapy. (Exception: Patients actively receiving IFN-alfa-2b, PEG-IFN-alfa-2b, or similar forms of IFN-alfa are permitted).
✕. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that are likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
✕. Pregnant or breast-feeding women.
✕. Known hypersensitivity to histone deacetylases (HDACs), zidovudine, belinostat or any component of the formulation(s).
✕. Acute hepatitis or decompensated liver disease unless due to lymphoma. Chronic hepatitis will be required to be on prophylactic treatment during the study if provided liver function test meet criteria listed above without evidence of cirrhosis to be eligible.
✕. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix, non-metastatic, non-melanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy.