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Durvalumab Combinations for T-Cell Lymphoma

This study is testing different combinations of several drugs for people with T-cell lymphoma. The drugs being studied are Durvalumab, Pralatrexate, Romidepsin, and oral 5-Azacitidine. Durvalumab works by blocking a protein called PD-L1. Pralatrexate and Romidepsin are types of chemotherapy, and 5-Azacitidine helps stop cancer cell growth. This trial is looking for the safest and most effective dose of these drug combinations. You may be able to join if you are over 18 and have newly diagnosed or relapsed/refractory (cancer that has come back or not responded to treatment) Peripheral T-Cell Lymphoma. The main goal is to find the highest dose that can be given without causing too many side effects, which will be measured over one year. The current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to find the right dose of drug combinations and plans to enroll 148 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of finding the maximum tolerated dose will be measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03161223

Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Virginia
~148 participants
Updated 2022-03-31 on ClinicalTrials.gov
What's tested:DurvalumabPralatrexateRomidepsin5-Azacitidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over 1 year

Conditions

Lymphoma, T-Cell

Explore related trials

Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

NCT03161223

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Virginia

    Charlottesville, Virginiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Enrica Marchi, M.D., PhD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Abdelmalek Marian
[email protected]
434-924-5834
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Age \>18 years at the time of signing the informed consent
Patients must have histologically confirmed newly diagnosed (ND) or Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL) defined according to the 2016 World Health Organization (WHO) classification criteria.
Patients with R/R PTCL who have received at least one previous line of therapy are eligible to be enrolled in this study.
Patients who are candidate for an autologous or allogeneic stem cell transplantation (SCT) will be allowed to receive the study drugs as a "bridge" to transplantation.
Evaluable (phase 1) or measurable (phase 2) disease.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients must have adequate organ and marrow function as defined by:
Ability to understand and the willingness to sign a written informed consent document.
Ability to adhere to the study visit schedule and other protocol requirements
Pregnancy or breast-feeding.
Active concurrent malignancy (except non-melanoma skin cancer, prostatic intraepithelial neoplasia, or carcinoma in situ of the cervix). Patients whose lymphoma has transformed from a less aggressive histology remain eligible.
Receipt of solid organ transplant.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, Crohn's disease\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.
Central nervous system (CNS) involvement, including lymphomatous meningitis.
Known active hepatitis A, B or C virus infection.
Known HIV infection.
History of primary immunodeficiency.
Receipt of live, attenuated vaccine within 30 days prior to study entry. Enrolled patients should not receive live vaccine during the study and 30 days after the last dose of durvalumab.

Exclusion

Prior Therapy (for patients with R/R PTCL)
History of, or suspected allergic reactions to, durvalumab, pralatrexate, oral 5-azacitidine, or romidepsin or any of their excipients.
For patients who are treated with oral 5-azacitidine, any gastrointestinal disorder that would interfere with the absorption of the study drug
Concomitant use of CYP3A4 inhibitors
Uncontrolled intercurrent illness.
Any of the following cardiac abnormalities (only for patients receiving romidepsin):

What this trial measures

  • Maximum Tolerated Dose (MTD)1 year

    The highest dose of study treatment that does not cause unacceptable side effects in patients with R/R PTCL in each study arm