Brentuximab Vedotin and Combination Chemotherapy in Treat... | NCT01771107

ID	Type	Description	Link
NCI-2013-00046	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2014-003678-18
085
AMC-085	Other Identifier	AIDS Malignancy Consortium
AMC-085	Other Identifier	CTEP
UM1CA121947	U.S. NIH Grant/Contract		View source

Name	Class
The Lymphoma Academic Research Organisation	OTHER

Description Module

Detailed Description

PRIMARY OBJECTIVES I. To identify the maximum tolerated dose (MTD) of brentuximab vedotin when combined with the doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) chemotherapy regimen in the treatment of HIV-associated stage II-IV Hodgkin lymphoma. (Phase I) II. Establish an estimate of the two-year progression-free survival (PFS) for participants with HIV-associated stage II-IV Hodgkin lymphoma when treated using brentuximab vedotin plus the AVD chemotherapy regimen. (Phase II)

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of AVD and brentuximab vedotin with highly active antiretroviral therapy (HAART).

II. To estimate the partial response (PR) rate, complete response (CR) rate, overall survival (OS), and event free survival (EFS) at 2 and 5 years.

III. To evaluate the effect of AVD and brentuximab vedotin on cluster of differentiation (CD)4 and CD8 counts after cycle 1, 4, at the end of therapy, and every 3 months after treatment completion for one year.

IV. To investigate the prognostic value of fludeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) scans at baseline, after cycle 2, and at treatment completion, with respect to 2-year progression free survival.

V. To evaluate HAART status at baseline and to correlate this with tumor response to therapy and OS and PFS.

VI. To characterize the histologic subtypes in HIV-Hodgkin lymphoma (HL) in the highly active antiretroviral therapy (HAART) era.

VII. To assess the neurotoxicity of HAART in combination with AVD and brentuximab vedotin.

VIII. To evaluate effect of AVD and brentuximab vedotin on viral load after cycles 1, 4, at the completion of therapy, and every 3 months after treatment completion for one year.

IX. To perform pharmacokinetic and immunogenicity studies to determine drug levels during therapy.

X. To perform micro ribonucleic acid (miRNA) profile analysis on the HIV-HL tumor specimens and to correlate miRNA expression with OS, PFS, tumor response to therapy, histologic subtype of HIV-HL, and HIV disease characteristics.

XI. To perform tissue microarray analysis on HIV-HL tumor specimens and to correlate the markers studied with OS, PFS, and tumor response to therapy.

XII. To identify Epstein-Barr virus (EBV)-associated tumor derived deoxyribonucleic acid (DNA) in the plasma of study participants and to correlate these levels during therapy with disease response and OS. (Phase II) XIII. To identify cytokines in the plasma of participants during therapy that can be used as tumor and prognostic markers. (Phase II) XIV. To assess latent and expressed HIV reservoirs before, during, and post chemotherapy. To understand how cytotoxic chemotherapeutic agents affect HIV expression.

OUTLINE: This is a phase I, dose-escalation study of brentuximab vedotin followed by a phase II study.

Patients receive doxorubicin hydrochloride intravenously (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.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Label	Type	Description	Intervention Names
Treatment (brentuximab and combination chemotherapy)	Experimental	Patients 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.	Drug: Brentuximab Vedotin Drug: Dacarbazine Drug: Doxorubicin Hydrochloride Other: Pharmacological Study Drug: Vinblastine

Name	Type	Description	Arm Group Labels	Other Names
Brentuximab Vedotin	Drug	Given IV	Treatment (brentuximab and combination chemotherapy)

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Frequency of Adverse Events	Number of Participants who had one or more adverse events	Up to 5 years
Partial Response Rate	Number of participants who achieved a partial response per RECIST v1.0 criteria

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
Ability to understand and the willingness to sign a written informed consent document
Karnofsky performance status > 30% (given the aggressiveness of this disease and the often severely debilitated nature of the patients at initial presentation)
Measurable or non-measurable (evaluable) tumor parameter(s); non-measurable tumor parameters will be defined as not having bi-dimensional measurements (i.e., gastric or marrow involvement) but can be followed for response by other diagnostic tests such as gallium, PET imaging and/or bone marrow biopsy
Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligible
CD4 count >= 50 cells/ul
Participants are required to be on antiretroviral regimens that are in accordance with the current International Acquired Immune Deficiency Syndrome (AIDS) Society guidelines concurrently with chemotherapy; the specific agents are at the discretion of the investigator and the use of investigational agents currently available on an expanded access basis is allowed; use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir or Kaletra), cobicistat, didanosine (Videx or Videx EC), or similar potent cytochrome P450 (CYP)3 inhibitors are prohibited; in order to be eligible, participants taking zidovudine or ritonavir, or cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation; changes to HAART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.); participants must be on HAART at least 7 days prior to therapy
Negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy; all participants will be required to be screened for hepatitis B; per Infectious Disease Society of America (IDSA) and Assistance for AIDS Specific Drugs (AASD) guidelines, those participants that show no immunity, defined by the lack of hepatitis B surface antigen antibody, and show evidence of chronic infection (i.e. hepatitis B surface antigen [HBsAg]+, hepatitis B core [HBcore]+, hepatitis B surface antibody [HBsAB]-) will be required to be on anti-hepatitis B therapy during the study in order to be eligible; patients will be permitted to enroll in the study provided normal liver function tests and no evidence of cirrhosis; the exact hepatitis B therapy will be at the discretion of the infection disease specialist or investigator; however all patients who present with acute hepatitis B or show normal transaminases and are hepatitis B virus HBsAg surface protein antigen (HBsAg) positive (+) and immunoglobulin M (IgM)+ for hepatitis core antigen will not be eligible for trial enrollment
Patients diagnosed with hepatitis C who are hepatitis C antibody positive, whether hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests
Brentuximab vedotin is partially metabolized via the CYP3A4 pathway and is cleared from the cells via the P-glycoprotein pump; therefore, participants must discontinue use of the following agents within 7 days prior to therapy
- Strong CYP3A4 inhibitors that treat HIV
- Other strong CYP3A inhibitors
- Moderate CYP3A4 inhibitors should be used with caution but are not excluded; if 2 moderate CYP3A4 inhibitors are used concurrently, one must be discontinued at least 7 days (1 week) prior to the initiation of chemotherapy
- P-glycoprotein inhibitors
- If patients are taking any of these excluded medications, they must be discontinued at least 7 days (1 week) prior to the initiation of chemotherapy All concomitant medications must be reviewed by the study chair or co-chair prior to enrollment by email; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference for a list of drugs to avoid or minimize use of

Exclusion Criteria:

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

Name	Affiliation	Role
Paul G Rubinstein	AIDS Malignancy Consortium	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UC San Diego Moores Cancer Center		La Jolla	California	92093	United States
UCLA Center for Clinical AIDS Research and Education

PubMed Identifier	Type	Citation	Retractions
37532416	Derived	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.
29280762

ID	Title	Description
FG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 15, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximal Tolerated Dose of Brentuximab Vedotin (Phase I)

Defined as the dose level at which =< 1 of 6 subjects experience dose limiting toxicity.

Participants entered into the phase I portion of the study

Posted

Number

mg/kg

28 days

ID	Title	Description
OG000	Treatment (Brentuximab and Combination Chemotherapy)	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units	Counts
Participants	OG0006

Title

Denominators

Categories

Title	Measurements
	OG0001.2

Primary

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.

Posted

Number

95% Confidence Interval

proportion of participants

2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Secondary

Frequency of Adverse Events

Number of Participants who had one or more adverse events

Participants who were treated with brentuximab and combination chemotherapy

Posted

Count of Participants

Participants

Up to 5 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Secondary

Partial Response Rate

Number of participants who achieved a partial response per RECIST v1.0 criteria

Patients who completed therapy

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Secondary

Partial Response Rate

Number of participants who achieved a partial response per RECIST v1.0 criteria

Posted

Count of Participants

Participants

5 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Units	Counts
Participants

Secondary

Complete Response Rate

Number of participants who experienced a complete response per RECIST v1.0 criteria

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units	Counts

Secondary

Complete Response Rate

Number of participants who achieved a complete response per RECIST v1.0 criteria

Posted

Count of Participants

Participants

5 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Units	Counts
Participants

Secondary

2-year Overall Survival

Proportion of study participants who are alive at 2 years estimated using the Kaplan-Meier survival function

Posted

Number

95% Confidence Interval

proportion of participants

2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units	Counts

Secondary

Overall Survival

Proportion of participants who are alive at 5 years using a Kaplan-Meier estimate

Posted

Number

95% Confidence Interval

proportion of participants

5 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Units	Counts
Participants

Secondary

Event-free Survival

Proportion of participants who are alive and progression-free at 2 years

Posted

Number

95% Confidence Interval

proportion of participants

2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units	Counts

Secondary

Event-free Survival

Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates (i.e., partial response rate, complete response rate, overall response rate) and event free survival at 2 and 5 years of AVD and brentuximab vedotin for a treatment of patients with stage III/IV HIV-associated Hodgkin lymphoma.

Posted

Number

95% Confidence Interval

proportion of participants

5 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Secondary

CD4 Counts

CD4 counts (absolute) at visit 4 (cycle 5)

Participants with absolute cd4 counts at cycle 5

Posted

Median

Inter-Quartile Range

cells/µL

5 months

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units

Secondary

CD8 Counts

Absolute CD8 counts at cycle 5

Participants with absolute CD8 counts at cycle 5

Posted

Median

Inter-Quartile Range

cells/µL

5 months

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units	Counts

Secondary

Viral Load

HIV viral load (detectable)

Posted

Count of Participants

Participants

5 months

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units	Counts
Participants

Secondary

Prognostic Value of Fludeoxyglucose F-18 (FDG)-Positron Emission Tomography (PET) in Patient With HIV and Hodgkin Lymphoma (HL) With Respect to 2 Year Progression Free Survival

Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 courses and post-therapy in patients with HIV and HL with respect to progression free survival.

PET-CT positive status was used within each arm.

Posted

Number

95% Confidence Interval

proportion of participants

Baseline up to 2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Secondary

Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival

PET-CT positive status was used within each arm.

Posted

Number

95% Confidence Interval

proportion of participants

Baseline up to 2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Secondary

Prognostic Value of FDG-PET in Patient With HIV and HL With Respect to 2 Year Progression Free Survival

PET-CT positive status was used within each arm.

Posted

Number

95% Confidence Interval

proportion of participants

Baseline up to 2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Secondary

HAART Status

Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of progression free survival at 2 years.

All participants had HAART at baseline. Logrank test cannot be performed.

Posted

Number

95% Confidence Interval

proportion of participants

Baseline up to 2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Secondary

HAART Status

Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of overall survival at 2 years.

All participant had HAART at baseline. Logrank test cannot be performed.

Posted

Number

95% Confidence Interval

proportion of participants

Baseline up to 2 years

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 m/kg	Patients 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. Brentuximab Vedotin: Given IV

Secondary

Characterization of Histologic Subtypes in HIV-HL in the HAART Era

Participants with mixed cellularity histologic subtype in HIV-HL in the HAART era

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Units	Counts

Secondary

Incidence of Neurotoxicity

Number of participants who experience neurotoxicity at cycle 5 (visit 4)

Participants who had neurotoxicity evaluated at cycle 5

Posted

Count of Participants

Participants

5 months

ID	Title	Description
OG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
OG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected35 at risk
Coronary artery disease	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Death, NOS	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Catheter related infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Neurosyphilis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Lung infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk
Sepsis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Carbon monoxide diffusing capacity decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Neutrophil count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected35 at risk
Platelet count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
White blood cell decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Intracranial hemorrhage	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0010 affected35 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected35 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk
Soft tissue infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0011 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG00117 affected35 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0014 affected35 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG00113 affected35 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected6 at risk EG0018 affected35 at risk
Oral mucositis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected35 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG00111 affected35 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected35 at risk
Chills	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected35 at risk
Fatigue	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG00111 affected35 at risk
Fever	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected35 at risk
Pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0017 affected35 at risk
Mucosal infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected35 at risk
alanine aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0016 affected35 at risk
Alkaline phosphatase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected6 at risk EG0017 affected35 at risk
Blood albumin increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected35 at risk
Lymphocyte count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0019 affected35 at risk
Neutrophil count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG00117 affected35 at risk
Platelet count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0018 affected35 at risk
White blood cell decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG00113 affected35 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0013 affected35 at risk
Hyperglycemia	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0013 affected35 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected35 at risk
Hypocalcemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0012 affected35 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected35 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected35 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0014 affected35 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected35 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0014 affected35 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0012 affected35 at risk
Headache	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0013 affected35 at risk
Paresthesia	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected35 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0014 affected35 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected6 at risk EG00116 affected35 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected6 at risk EG0013 affected35 at risk
Depression	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0013 affected35 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected6 at risk EG0013 affected35 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0016 affected35 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected6 at risk EG0016 affected35 at risk
Maculo-papular rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected6 at risk EG0014 affected35 at risk
Anal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Gastroesophageal reflux	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Non-cardiac pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Allergic reaction	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk
Shingles	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk
Skin infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected6 at risk EG0015 affected35 at risk
Carbon monoxide diffusing capacity decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected35 at risk
Creatinine increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk
Weight gain	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Weight loss	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected35 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Hypophosphatemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk
Generalized muscle cramp	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected35 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Urinary frequency	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0011 affected35 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected6 at risk EG0012 affected35 at risk
Thromboembolic event	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected6 at risk EG0010 affected35 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines

ID	Title	Description
BG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
BG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase I - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV	0	6	3	6	6	6
EG001	Phase II - Brentuximab 1.2 mg/kg	Patients 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. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV	3	35	16	35	34	35

ID	Term
D000079963	Brentuximab Vedotin
D003606	Dacarbazine
D004317	Doxorubicin
D014747	Vinblastine