Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Leukemia

Leukemia, T-Cell

Leukemia-Lymphoma, Adult T-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, Lymphoid

Lymphosarcoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Belinostat

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon alpha-2

Zidovudine

Interferon-alfa-1b

Antiviral Agents

Immunologic Factors

Antimetabolites

Reverse Transcriptase Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Histone Deacetylase Inhibitors

Belinostat + Zidovudine (AZT) in combination as consolidation therapy, followed by standard zidovudine (AZT)-based maintenance therapy with optional Interferon-Alfa-2b (IFNalfa-2b) or Pegylated Interferon-Alfa-2b (PEG-IFN-alfa-2b)

Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1- 5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1\*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.

Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO), three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.

OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.

Interferon-Alfa-2b

Pegylated Interferon-Alfa-2b

Karin Suarez

Juan C Ramos, MD

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

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

A Phase II Trial of Belinostat as Consolidation Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

Proportion of participants achieving Complete Molecular Response after receiving protocol therapy. Complete Molecular Response (CMR) is defined as no evidence of disease at any body sites AND the disappearance of malignant clone(s), as proven by negative T-cell receptor gene rearrangement studies of peripheral blood DNA. Molecular response will be evaluated based upon T-cell clonality studies to be conducted while subjects are on Belinostat, and while subjects are receiving AZT-based maintenance treatment (after Belinostat completion).

The proportion of subjects with minimal residual disease (MRD) will also be reported. Minimal Residual Disease (MRD) is defined as the presence of malignant clone(s) as determined by negative T-cell receptor gene rearrangement studies of peripheral blood DNA.

Proportion of participants experiencing treatment-related serious adverse events (SAEs), and adverse events (AEs). SAEs and AEs will be assessed by and assigned severity and treatment attribution using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE), Version 4.03.

Rate of participants achieving complete response (CR) or partial response (PR) to protocol therapy. Response is assessed on the basis of clinical, radiologic, molecular and pathologic (i.e.

bone marrow) criteria.

Subjects will be evaluated during treatment and by follow-up assessments post-treatment. 1-year FFS is defined as the time from study treatment initiation until documented disease progression, relapse after response or death (by any cause, in the absence of progression). In the failure-free subjects, FFS will be censored at the last documented date of failure-free status.

Follow-up for OS post-treatment will occur every 3 months during year 1 post treatment under the proposed study. OS is defined as the elapsed time from study treatment initiation to death or date of censoring. Subjects alive or those lost to follow-up will be censored at the last date known to be alive.

Cytotoxic T-Cell response will be evaluated from serum blood samples, as well as molecular evaluation of ATLL and HTLV-1 clones

Spots Global Cancer Trial Database for Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

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Interventions

Study Description

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