New combo shows promise against tough lymphoma
NCT ID NCT03113500
First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This phase 2 trial tests a new combination treatment for a rare type of lymphoma (CD30-positive peripheral T-cell lymphoma). It combines a targeted drug (brentuximab vedotin) with standard chemotherapy. The goal is to see if this approach improves the number of patients who achieve complete remission. The study enrolled 48 adults and is no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brentuximab vedotin plus chemotherapy (cyclophosphamide, doxorubicin, etoposide, prednisone)
- What this could lead to
- If successful, this combination could offer a more effective first-line treatment for CD30-positive peripheral T-cell lymphoma, potentially leading to higher remission rates.
- What could go wrong
- This is a small, early-phase (Phase 2) study with only 48 participants. Results may not apply to all patients, and side effects from the chemotherapy and targeted drug could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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48 people
The number who actually took part.
- Started
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May 2017
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of participant and/or legally authorized representative * Agreement to allow the use of archival tissue from diagnostic tumor biopsies will be retrieved and submitted post-enrollment * If unavailable, exceptions may be granted with study principal investigator (PI) approval. * Eastern Cooperative Oncology Group (ECOG) status =\< 2 * Histologically confirmed mature peripheral T-cell or natural killer (NK)-cell lymphoma per World Health Organization (WHO) classification, including: * Anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) with international protein index (IPI) of 2 or higher (must have bulky \[defined as mass \>= 10 cm\] stage II, or stage III-IV disease) * ALK-negative ALCL * NOTE: Per amendment dated 05-10-19, ALCL will no longer be eligible except for Canada. * PTCL-not otherwise specified (NOS) * Angioimmunoblastic T-cell lymphoma (AITL) * Adult T-cell lymphoma/leukemia (ATLL) * Enteropathy-associated T-cell lymphoma (EATL) * Hepatosplenic T-cell lymphoma * CD30-positivity (e.g. at least 1%) by immunohistochemistry confirmed by hematopathology review at the participating institution * Measurable disease of at least 1.5 cm on computed tomography (CT) or positron emission tomography (PET)-CT scan * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Exception: unless documented bone marrow involvement by lymphoma * Platelets \>= 50,000/mm\^3 * Exception: unless documented bone marrow involvement by lymphoma * Total serum bilirubin =\< 1.5 x upper limit of normal (ULN) OR if hepatic involvement by lymphoma: =\< 3 x ULN for Gilbert's disease or documented hepatic involvement by lymphoma * Aspartate aminotransferase (AST) =\< 2 x ULN OR if hepatic involvement by lymphoma: AST =\< 5 x ULN * Alanine aminotransferase (ALT) =\< 2 x ULN OR if hepatic involvement by lymphoma: ALT =\< 5 x ULN * Creatinine clearance of \>= 60 mL/min per the Cockcroft-Gault formula * Left ventricular ejection fraction (LVEF) \>= 45% * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by WOCBP and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy; childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Prior treatment of PTCL with systemic anti-lymphoma therapies, investigational agents, radiation * Exception: May have received 1 cycle of CHOP-like therapy (e.g. CHOP, CHOEP, EPOCH) or 1 cycle of CHP-BV; these participants must initiate day 1 cycle 1 of study therapy (CHEP-BV) no less than 19 days from prior CHOP-like or CHP-BV therapy; Patients who received 1 cycle of CHOP-like or 1 cycle of CHP-BV therapy prior to initiating induction with CHEP-BV are allowed to receive only 5 cycles of CHEP-BV instead of 6 cycles, per investigator's discretion * History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. * Exceptions: Non-melanoma skin cancer and in situ cervical cancer * Symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), cerebrovascular event/stroke or myocardial infarction within the past 6 months * Central nervous system involvement by lymphoma, including leptomeningeal involvement * History of progressive multifocal leukoencephalopathy (PML) * Active \>= grade 3 viral, bacterial, or fungal infection within 2 weeks prior to day 1 of protocol therapy * Any known human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection * Baseline peripheral neuropathy \>= grade 2 or patients with the demyelinating form of Charcot-Marie-Tooth syndrome * Known severe hypersensitivity to any study related agent excipient(s) * Females only: pregnant or breastfeeding * Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
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City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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