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NCT03113500 · REGISTRY CONDITION SEARCH

Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-08-21

This phase II trial studies the side effects and how well brentuximab vedotin and combination chemotherapy work in treating patients with CD30-positive peripheral T-cell lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, etoposide, and prednisone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin and combination chemotherapy may work better in treating patients with CD30-positive peripheral T-cell lymphoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy

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outcome · POSTED

Overall Survival at 1 Year

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    INDUCTION: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone PO on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of CHOP-like or CHP-BV therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Brentuximab Vedotin
    2. Drug: Cyclophosphamide
    3. Drug: Doxorubicin
    4. Drug: Doxorubicin Hydrochloride
    5. Drug: Etoposide
    6. Drug: Etoposide Phosphate
    7. Other: Laboratory Biomarker Analysis
    8. Drug: Prednisone
    label
    Treatment (CHEP-BV)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Given IV
    name
    Brentuximab Vedotin
    other Names
    1. ADC SGN-35
    2. Adcetris
    3. Anti-CD30 Antibody-Drug Conjugate SGN-35
    4. Anti-CD30 Monoclonal Antibody-MMAE SGN-35
    5. Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35
    6. cAC10-vcMMAE
    7. SGN-35
    type
    DRUG
  2. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Given IV
    name
    Cyclophosphamide
    other Names
    1. (-)-Cyclophosphamide
    2. 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
    3. Carloxan
    4. Ciclofosfamida
    5. Ciclofosfamide
    6. Cicloxal
    7. Clafen
    8. Claphene
    9. CP monohydrate
    10. CTX
    11. CYCLO-cell
    12. Cycloblastin
    type
    DRUG
  3. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Given IV
    name
    Doxorubicin
    other Names
    1. Adriablastin
    2. Hydroxydaunomycin
    3. Hydroxyl Daunorubicin
    4. Hydroxyldaunorubicin
    type
    DRUG
  4. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Given IV
    name
    Doxorubicin Hydrochloride
    other Names
    1. 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
    2. ADM
    3. Adriacin
    4. Adriamycin
    5. Adriamycin Hydrochloride
    6. Adriamycin PFS
    7. Adriamycin RDF
    8. ADRIAMYCIN, HYDROCHLORIDE
    9. Adriamycine
    10. Adriblastina
    11. Adriblastine
    12. Adrimedac
    type
    DRUG
  5. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Given IV
    name
    Etoposide
    other Names
    1. Demethyl Epipodophyllotoxin Ethylidine Glucoside
    2. EPEG
    3. Lastet
    4. Toposar
    5. Vepesid
    6. VP 16
    7. VP 16-213
    8. VP-16
    9. VP-16-213
    10. VP16
    type
    DRUG
  6. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Given IV
    name
    Etoposide Phosphate
    other Names
    1. Etopophos
    type
    DRUG
  7. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  8. arm Group Labels
    1. Treatment (CHEP-BV)
    description
    Given PO
    name
    Prednisone
    other Names
    1. .delta.1-Cortisone
    2. 1, 2-Dehydrocortisone
    3. Adasone
    4. Cortancyl
    5. Dacortin
    6. DeCortin
    7. Decortisyl
    8. Decorton
    9. Delta 1-Cortisone
    10. Delta-Dome
    11. Deltacortene
    12. Deltacortisone
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
48
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval.
    measure
    Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
    time Frame
    Up to the end of the CHEP-BV treatment
secondary Outcomes
  1. description
    Overall survival (OS) was measured from enrollment to death from any cause. OS was estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error.
    measure
    Overall Survival at 1 Year
    time Frame
    The time from enrollment to death from any cause assessed up to 1 year.
Full study description
brief Summary
This phase II trial studies the side effects and how well brentuximab vedotin and combination chemotherapy work in treating patients with CD30-positive peripheral T-cell lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, etoposide, and prednisone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin and combination chemotherapy may work better in treating patients with CD30-positive peripheral T-cell lymphoma.
detailed Description
PRIMARY OBJECTIVES: I. Assess the safety and tolerability of cyclophosphamide, doxorubicin hydrochloride (doxorubicin), etoposide phosphate (etoposide), prednisone, and brentuximab vedotin (CHEP-BV), as induction therapy in patients with CD30-positive peripheral T-cell lymphoma (PTCL). (Safety lead-in) II. Assess the anti-lymphoma activity of CHEP-BV as induction treatment in patients with CD30-positive PTCL. (Phase 2) SECONDARY OBJECTIVES: I. Describe outcomes of CD30-positive PTCL patients who go on to receive BV consolidation therapy post CHEP-BV induction with/without autologous hematopoietic cell transplantation/radiation. EXPLORATORY OBJECTIVES: I. Explore the rate of minimal residual disease (MRD) negativity (as assessed by next-generation sequencing) and MRD kinetics after CHEP-BV and BV consolidation therapy in CD30-positive PTCL. II. Explore the possible association between outcome after study treatment and CD30 expression, gene expression profiles (GEP), and genetic mutations as measured in PTCL tumor samples. OUTLINE: INDUCTION: Patients receive cyclophosphamide intravenously (IV) and doxorubicin IV on day 1, etoposide IV on days 1-3, and prednisone orally (PO) on days 1-5. Patients also receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (or for up to 5 cycles for patients who received 1 cycle of cyclophosphamide, doxorubicin, vincristine and prednisone \[CHOP\]-like or brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone \[CHP-BV\] therapy prior to induction, per investigator's discretion) in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Between 30-60 days post-consolidative autologous stem cell therapy, post-consolidative radiation therapy, or after completing induction cycle 6 (cycle 5 for patients who qualify for receiving 5 cycles of CHEP-BV instead of 6), patients with objective response (complete response or partial response) receive brentuximab vedotin IV over approximately 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, 6 months, and 12 months.
Source references
references
  1. citation
    Herrera AF, Zain J, Savage KJ, Feldman T, Brammer JE, Chen L, Puverel S, Popplewell L, Budde LE, Mei M, Hosing C, Nair R, Leslie L, Daniels S, Peters L, Forman S, Rosen S, Kwak L, Iyer SP. Brentuximab vedotin plus cyclophosphamide, doxorubicin, etoposide, and prednisone followed by brentuximab vedotin consolidation in CD30-positive peripheral T-cell lymphomas: a multicentre, single-arm, phase 2 study. Lancet Haematol. 2024 Sep;11(9):e671-e681. doi: 10.1016/S2352-3026(24)00171-6. Epub 2024 Jul 24.
    pmid
    39067464
    type
    DERIVED
Source notices and limitations
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    Preserved source evidence · Not medical advice