Romidepsin Versus Combination of Romidepsin Plus Pralatrexate in PTCL

NCT03355768 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: AAAR5550
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lymphoma, T-Cell, Peripheral

Keywords

Romidepsin; Pralatrexate; PTCL; Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Compare the progression free survival (PFS) in patients with R/R PTCL treated with romidepsin versus the combination of romidepsin plus pralatrexate.

  up to 3 years

Secondary Outcomes (7)

• Complete Response (CR)

  up to 3 years

• Duration of response (DOR)

  up to 3 years

• Overall survival (OS)

  up to 3 years

• Overall response rate (ORR)

  up to 3 years

• Time to Treatment Progression (TTP)

  up to 3 years

Study Arms (2)

Romidepsin Arm

EXPERIMENTAL

Control Arm: Subjects will receive Romidepsin 14 mg/m2 on Days 1, 8, 15.

Drug: Romidepsin

Romidepsin + Pralatrexate Combination Arm

EXPERIMENTAL

Combination Arm: Subjects will receive Romidepsin 12 mg/m2 and Pralatrexate 25 mg/m2.

Drug: Romidepsin; Drug: Pralatrexate

Interventions

Romidepsin DRUG

Intravenous administration on a 28 day cycle

Also known as: Istodax

Romidepsin + Pralatrexate Combination Arm; Romidepsin Arm

Pralatrexate DRUG

Intravenous administration on a 28 day cycle

Also known as: Folotyn

Romidepsin + Pralatrexate Combination Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Amengual: lead
• Columbia University: collaborator

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

romidepsin; 10-propargyl-10-deazaaminopterin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jennifer E Amengual, MD

  Center for Lymphoid Malignancies Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 28, 2017
• Study Start: September 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12