Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma
A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma
5 other identifiers
interventional
41
2 countries
28
Brief Summary
This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug 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 doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, 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 together with combination chemotherapy may kill more cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
Longer than P75 for phase_1
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedStudy Start
First participant enrolled
March 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedResults Posted
Study results publicly available
March 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2024
CompletedAugust 15, 2025
August 1, 2025
8.6 years
January 16, 2013
October 26, 2022
August 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Maximal Tolerated Dose of Brentuximab Vedotin (Phase I)
Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.
28 days
2-year Progression-free Survival (PFS) (Phase II)
2-year PFS is determined based on the Kaplan-Meier estimates and corresponding 95% confidence intervals based on standard errors using Greenwood's formula.
2 years
Secondary Outcomes (18)
Frequency of Adverse Events
Up to 5 years
Partial Response Rate
2 years
Partial Response Rate
5 years
Complete Response Rate
2 years
Complete Response Rate
5 years
- +13 more secondary outcomes
Study Arms (1)
Treatment (brentuximab and combination chemotherapy)
EXPERIMENTALPatients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- HIV positive; documentation of HIV-1 infection by means of any one of the following:
- Documentation of HIV diagnosis in the medical record by a licensed health care provider;
- Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider;
- HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \> 1000 RNA copies/mL;
- Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 western blot confirmation or HIV rapid multispot antibody differentiation assay
- NOTE: A "licensed" assay refers to a United States (US) Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies
- Histologic diagnosis of CD30-positive classical HL as defined by the 2008 World Health Organization (WHO) Classification of Hematological diseases; nodular lymphocyte predominant Hodgkin lymphoma is not eligible
- Stage II, III or IV disease as defined by the Ann Arbor Staging System
- Participants must have previously untreated HIV-classical HL (cHL), with the exception of up to 14 consecutive days of steroids, emergency radiation, or 1 prior cycle of cyclophosphamide to reduce tumor burden and improve hyperbilirubinemia in the setting of lymphoma related liver involvement
- Normal baseline cardiac ejection fraction \>= 50%
- Serum creatinine of =\< 1.5 mg/dL; if creatinine \> 1.5 mg/dL, creatinine clearance must be \>= 60 mL/minute
- Absolute neutrophil count (ANC) \>= 1000/uL
- Platelets \>= 75,000/uL unless related to bone marrow involvement by HIV-cHL
- Total bilirubin must be \< 1.5 x the upper limit of normal, unless the elevation of bilirubin is thought to be secondary to Gilbert's syndrome or combined antiretroviral therapy (cART); if, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =\< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x the upper limit of normal; also, if the elevated bilirubin is thought to be secondary to cHL the same criteria for hyperbilirubinemia should be applied; however 1 prior cycle of cyclophosphamide is permitted in attempt to make the participant eligible; patients should not be excluded from study participation unless dosing cannot be safely established
- Female participants must have a negative pregnancy test within 1 week of enrollment and all participants must agree to use two reliable methods of contraception simultaneously if conception is possible during the study and for 6 months after stopping treatment; should a woman subject become pregnant or suspect she is pregnant while the subject is participating in this study, she should inform her treating physician immediately; the participant will then be removed from protocol therapy; participants who father a child while participating in the study will be permitted to continue with the protocol; the participant, however, is required to notify the investigator if he fathers a child
- +14 more criteria
You may not qualify if:
- Patients with prior anthracycline therapy will be excluded
- Female participants who are pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) or urine pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
- Medical illness unrelated to HL, which in the opinion of the study physician will preclude administration of chemotherapy safely; this includes patients with uncontrolled infection (including opportunistic), chronic renal failure, myocardial infarction (MI) within the past 6 months, unstable angina, or cardiac arrhythmias other than chronic atrial fibrillation, or second malignancy requiring active treatment
- Prior malignancy within 2 years before enrollment other than curatively treated cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, anal intraepithelial neoplasia, or cutaneous Kaposi's sarcoma (KS); participants with prior malignancies must have completed all therapy at least 2 years before enrollment with no evidence of disease since therapy completion
- Grade 2 or greater peripheral neuropathy
- Evidence of progressive multifocal leukoencephalopathy (PML) identified on the pretreatment magnetic resonance imaging (MRI)
- Central nervous system disease
- Patients with history of John Cunningham (JC) virus identified in the cerebrospinal fluid (CSF) or previous history of PML will be excluded from the study
- Cirrhosis secondary to any cause will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
UCLA Center for Clinical AIDS Research and Education
Los Angeles, California, 90035, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Siteman Cancer Center at Washington University
St Louis, Missouri, 63110, United States
Washington University - Jewish
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Centre Hospitalier Universitaire (CHU) de Toulouse
Cedex, 31059, France
Hopital Antoine Beclere
Clamart, 92140, France
Henri Mondor University-Hospital Center
Créteil, 94000, France
Hopital l'Archet-CHU de Nice
Nice, 06202, France
Hopital Saint Louis
Paris, 75010, France
Hospital Saint-Antoine
Paris, 75012, France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310, France
Chu Purpan
Toulouse, 31059, France
Related Publications (2)
Rubinstein PG, Moore PC, Bimali M, Lee JY, Rudek MA, Chadburn A, Ratner L, Henry DH, Cesarman E, DeMarco CE, Costagliola D, Taoufik Y, Ramos JC, Sharon E, Reid EG, Ambinder RF, Mitsuyasu R, Mounier N, Besson C, Noy A; AIDS Malignancy Consortium; Lymphoma Study Association. Brentuximab vedotin with AVD for stage II-IV HIV-related Hodgkin lymphoma (AMC 085): phase 2 results from an open-label, single arm, multicentre phase 1/2 trial. Lancet Haematol. 2023 Aug;10(8):e624-e632. doi: 10.1016/S2352-3026(23)00157-6.
PMID: 37532416DERIVEDRubinstein PG, Moore PC, Rudek MA, Henry DH, Ramos JC, Ratner L, Reid E, Sharon E, Noy A; AIDS Malignancy Consortium (AMC). Brentuximab vedotin with AVD shows safety, in the absence of strong CYP3A4 inhibitors, in newly diagnosed HIV-associated Hodgkin lymphoma. AIDS. 2018 Mar 13;32(5):605-611. doi: 10.1097/QAD.0000000000001729.
PMID: 29280762DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kimberly Mosby-Griffin
- Organization
- Emmes Company
Study Officials
- PRINCIPAL INVESTIGATOR
Paul G Rubinstein
AIDS Malignancy Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2013
First Posted
January 18, 2013
Study Start
March 8, 2013
Primary Completion
October 15, 2021
Study Completion
March 21, 2024
Last Updated
August 15, 2025
Results First Posted
March 3, 2023
Record last verified: 2025-08