Durvalumab with or without Lenalidomide for Relapsed/Refractory T-Cell Lymphoma
This study is looking at durvalumab, with or without lenalidomide, for people with cutaneous or peripheral T-cell lymphoma that has returned or isn't responding to other treatments. Durvalumab is a monoclonal antibody that may stop cancer cells from growing and spreading. Lenalidomide is a chemotherapy drug that also works to stop cancer cell growth. Researchers want to find the best dose of lenalidomide when given with durvalumab, understand the side effects, and see how well this combination works to shrink tumors. Success will be measured by how many patients respond to treatment and how long that response lasts. This study is currently recruiting patients aged 18 and older.
- Study design
- This is a randomized Phase 1/2 interventional study planning to enroll 78 participants. It aims to find the best dose and then evaluate the effectiveness of the treatments.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Response to treatment will be assessed for up to 12 months, and the duration of complete response will also be tracked for up to 12 months.
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Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma
At a glance
Conditions
NCT03011814
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope Medical Center
Duarte, Californiastudy coordinator listed
Recruiting
M D Anderson Cancer Center
Houston, Texasno site contact published
Withdrawn
Memorial Sloan-Kettering Cancer Center
New York, New Yorkno site contact published
Withdrawn
Thomas Jefferson University Hospital
Philadelphia, Pennsylvaniano site contact published
Withdrawn
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
- Christiane Querfeld, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- CTCL specific response assessed by Lugano ClassificationUp to 12 months
CTCL response was used to establish global response, which incorporates nodal, visceral and cutaneous lesions/disease. mSWAT tool was used for documenting responses in skin of patients with CTCL. PTCL specific response assessment criteria per Lugano Classification was used.
- Dose limiting toxicity assessed by CTCAE version 4.03Up to 84 days
Observed toxicities was summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
- Duration of Complete ResponseDate when criteria for CR first met until time of loss of CR (relapse/recurrence) or death (as a result of MF/SS or acute toxicity of treatment), assessed up to 12 months
Duration of complete response (CR) was defined as the time interval from the date of first documented complete response to the date of first documented disease relapse, progression or death whichever occurs first.
- Event-Free SurvivalFrom date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first, assessed up to 12 months
Event-free survival was defined as the time interval from date of first dose of study drug to first documented disease relapse, progression or death from any cause, whichever occurs first. Event-free survival was estimated using the product-limit method of Kaplan and Meier.
- Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03Up to 90 days post-treatment
Observed toxicities was summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
- Overall Response Rate (ORR)Up to 12 months
ORR was defined as proportion of patients with complete response (CR) and partial response (PR). The overall response rate and 95% Clopper Pearson binomial confidence interval (CI) was calculated.
- Overall survival (OS)From date of first dose of study drug to date of death from any cause, assessed up to 12 months
OS was defined as the time interval from date of first dose of study drug to date of death from any cause. OS was estimated using the product-limit method of Kaplan and Meier.
- Progression Free Survival (PFS)Date of initiation of treatment to first date meets criteria for progressive disease or death as a result of any cause, assessed up to 12 months
PFS was date of initiation of treatment to first date meets criteria for PD or death as a result of any cause.
- Response durationFrom the date of first documented response to the date of first documented disease relapse, progression or death whichever occurs first, assessed up to 12 months
95% Clopper Pearson binomial confidence interval will be calculated. Response rates will also be explored based on number/type of prior therapies.
- Time to responseDate of initiation of treatment to date when criteria for response (PR or CR) first met, assessed up to 12 months