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Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

ConditionPTCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

The purpose of this study is to find out whether the combination treatment of romidepsin and oral azacytidine is safe and effective in patients with Peripheral T-Cell Lymphoma (PTCL). This study will compare the experimental combination treatment of romidepsin and oral azacytidine to single agent drugs already determined effective in patients with PTCL. For the purposes of this study, the single agent drugs already used to treat lymphoma are called investigator's choice (IC), meaning the investigator will choose which one of these drugs to administer. The IC drug options include romidepsin, belinostat, pralatrexate or gemcitabine given alone. Funding Source: FDA OOPD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients are required to have no more than 3 lines of prior therapy (with cytoreductive therapy [ex ICE, DHAP, etc.] 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.

Patients with anaplastic large cell lymphoma are required to have received brentuximab vedotin (Bv) prior to study enrollment.

Measurable Disease as defined in Section 8.1.3.1.

Age ≥18 years.

Disqualifiers

Diagnosis of patch/plaque stage mycosis fungoides

Prior Therapy: Prior exposure to any hypomethylating agent or any histone deacetylase inhibitor (ex: romidepsin, chidamide, belinostat, or vorinostat); 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 within 2 weeks of enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azacytidine

    Drug

    Azacytidine, 300 mg po daily on Days 1-14

  • Romidepsin

    Drug

    Romidepsin, 14 mg/m2 as an intravenous infusion over 4 hours on Days 8, 15, and 22 of a 35-day cycle

  • Belinostat

    Drug

    Belinostat, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1-5 every 21 days.

  • Pralatrexate

    Drug

    Pralatrexate, 30 mg/m2 as an intravenous infusion over a 3-5 minute push once weekly for 6 weeks of a 7 week treatment cycle.

  • Gemcitabine

    Drug

    Gemcitabine, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28 day cycle.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: AZA and ROMIExperimental treatment 2 interventions
Group B: Investigator's ChoiceActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Difference in progression free survival in subjects treated with AZA/ROMI versus pre-specified investigator choice.

Time frame
Day of randomization to day of progression or death, whichever comes first; or date of last disease assessment or date of transition to other treatment for those without an event, up to 72 weeks.

Secondary outcomes

1

Overall survival

Difference in overall survival in subjects treated with AZA/ROMI versus pre-specified investigator choice.

Time frame
Day of randomization to day of death, whichever comes first; or date of last contact for those without an event, up to 72 weeks.
2

Complete response rate

Difference in complete response (CR) rate in subjects treated with AZA/ROMI versus pre-specified investigator choice, based on the Revised Criteria for Response Assessment.

Time frame
Day of first objective response to 8 weeks following last dose of study treatment
3

Overall response rate

Difference in overall response (OR) rate in subjects treated with AZA/ROMI versus pre-specified investigator choice, based on the Revised Criteria for Response Assessment.

Time frame
Day of first objective response to 8 weeks following last dose of study treatment
4

Duration of response rate

Difference in duration of response (DOR) rate in subjects treated with AZA/ROMI versus pre-specified investigator choice, based on the Revised Criteria for Response Assessment.

Time frame
Day of first objective response to day of progression or death, whichever comes first; or date of last disease assessment or date of transition to other treatment for those without an event, up to 72 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Celgene

Collaborator

Source ClinicalTrials.gov
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