Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL

• Status: Withdrawn
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Amengual
• Collaborator: Columbia University
• Treatments: Aminopterin; Romidepsin

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed relapsed or refractory aggressive peripheral T-cell lymphoma as defined by 2016 World Health Organization (WHO) criteria (excluding nasal natural killer t-cell (NK-T) and blastic natural killer (NK))

• Patients are required to have no more than 5 lines of prior therapy (with cytoreductive therapy followed by autologous stem cell transplant counting as one line of therapy. Patients are eligible if they have relapsed after prior autologous or allogeneic stem cell transplant

• Measurable Disease

• Age >18 years

• Eastern Cooperative Oncology Group (ECOG) performance status <2

• Patients must have adequate organ and marrow function

• Adequate contraception

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Prior Therapy

• Prior exposure to pralatrexate or a histone deacetylase inhibitor (romidepsin, chidamide, belinostat, or vonrinostat)

• Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.

• Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs.

• No other concurrent investigational agents are allowed.

• Central nervous system metastases, including lymphomatous meningitis

• Uncontrolled intercurrent illness

• Pregnant women

• Nursing women

• Current malignancy or history of a prior malignancy

• Patient known to be Human Immunodeficiency Virus (HIV)-positive

• Active Hepatitis A, Hepatitis B, or Hepatitis C infection