Phase 2 Lymphoma Trial, Recruiting NCT03161223 Sponsor: University of Virginia Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT03161223
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged over 18 years at the time of signing the consent form
  • People who have been diagnosed with a type of blood cancer called Peripheral T-Cell Lymphoma (PTCL), either newly diagnosed or that has come back or stopped responding to treatment, confirmed by a tissue test
  • People with PTCL that has come back or stopped responding to treatment, who have already received at least one previous cancer treatment
  • People who are being considered for a stem cell transplant (using their own or a donor's cells) may be able to receive the study drugs as a temporary treatment before the transplant
  • People whose disease can be measured or evaluated on scans or tests
  • People who are well enough to carry out daily activities, based on a standard medical scoring system (a score of 2 or lower on the ECOG scale)
  • People whose liver is working well enough, based on blood test results within accepted ranges (confirm specific values with trial site)
  • People whose kidneys are working well enough, based on blood test results within accepted ranges (confirm specific values with trial site)
  • People whose blood cell counts are within acceptable levels (confirm specific values with trial site)
  • Women who could become pregnant must have a negative pregnancy test before starting, and must agree to use effective contraception during treatment and for at least one month after finishing the study drugs
  • Men must agree to use effective contraception during treatment and for at least three months after finishing the study drugs
  • People who are willing and able to sign a consent form and understand what the trial involves
  • People who are able to attend scheduled visits and follow the trial's requirements

Who may not be able to join:

  • People who have previously been treated with drugs that target certain parts of the immune system known as PD-1, PD-L1, or CTLA-4
  • People who have previously received too many of the specific drugs being tested in this trial (the exact combination depends on which treatment group is being considered — confirm with trial site)
  • People who have received chemotherapy, immunotherapy, biological therapy, radiation, or any experimental cancer treatment within the two weeks before starting the trial, or who still have significant side effects from a previous cancer treatment
  • People who have used medications that suppress the immune system within 14 days before the first dose (with some exceptions for low-dose or locally applied steroids — confirm with trial site)
  • People who have previously had an allogeneic stem cell transplant (using a donor's cells)
  • People with known or suspected allergic reactions to any of the study drugs (durvalumab, pralatrexate, oral 5-azacitidine, or romidepsin) or their ingredients
  • People receiving oral 5-azacitidine who have a gut or digestive condition that could prevent the drug from being properly absorbed
  • People currently taking certain medications known as CYP3A4 inhibitors (confirm with trial site)
  • People with a serious illness that is not currently under control
  • People being treated with romidepsin who have certain heart conditions, including but not limited to: a hereditary heart rhythm disorder called long QT syndrome; an abnormal heart rhythm reading on an ECG; a heart attack within the past six months; certain types of heart blockage or very slow heart rate; heart failure; uncontrolled high blood pressure (160/95 or above); a history of serious dangerous heart rhythms; or a heart condition requiring anti-arrhythmia medication (excluding stable beta-blockers) — confirm full list with trial site
  • People who are pregnant or breastfeeding
  • People who have another active cancer (exceptions may apply for certain minor skin cancers, early prostate changes, or early cervical cell changes — confirm with trial site)
  • People who have received a solid organ transplant (such as a kidney or liver transplant)
  • People who have had an active autoimmune or inflammatory condition (such as lupus, Crohn's disease, rheumatoid arthritis, or similar conditions) within the past three years before starting treatment — some exceptions may apply (confirm with trial site)
  • People with lymphoma that has spread to the brain or spinal fluid
  • People with a currently active hepatitis A, B, or C infection
  • People with a known HIV infection
  • People with a history of a primary immune deficiency condition
  • People who have received a live vaccine within 30 days before joining the trial, or who would need one during the trial or within 30 days after the last dose of durvalumab

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Enrica Marchi, M.D., PhD, University of Virginia

Phone: 434-924-5834

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
30 May 2018
Est. completion
1 February 2023

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov