Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01771107
First received: January 16, 2013
Last updated: August 24, 2016
Last verified: August 2016

January 16, 2013
August 24, 2016
March 2013
June 2018   (final data collection date for primary outcome measure)
  • Maximal tolerated doses of brentuximab vedotin when combined with the AVD chemotherapy regimen, defined as the dose level at which =< 1 of 6 subjects experience dose limiting toxicity (Phase I) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Progression-free survival for patients using brentuximab vedotin plus AVD regimen with HIV-associated advanced stage Hodgkin lymphoma (Phase II) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Will be done using Kaplan-Meier estimates and corresponding 95% confidence intervals based on standard errors using Greenwood's formula.
  • Maximal tolerated doses of brentuximab vedotin when combined with the AVD chemotherapy regimen in HIV patients with advanced stage Hodgkin lymphoma (Phase I) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Progression-free survival for patients using brentuximab vedotin plus AVD regimen with HIV-associated advanced stage Hodgkin lymphoma (Phase II) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01771107 on ClinicalTrials.gov Archive Site
  • CD4 counts [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Repeated measures analysis of variance (ANOVA) models will be used to evaluate the effect of AVD and brentuximab vedotin on CD4 counts after 1, 4, and 6 courses, and every 3 months after treatment completion for one year.
  • CD8 counts [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Repeated measures ANOVA models will be used to evaluate the effect of AVD and brentuximab vedotin on CD8 counts after 1, 4, and 6 courses, and every 3 months after treatment completion for one year.
  • Characterization of histologic subtypes in HIV-HL in the HAART era [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Complete response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Complete response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Event-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • Event-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.
  • HAART status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of overall survival and progression free survival. The frequency and proportion of different histologic subtypes will be calculated.
  • Incidence of adverse events of AVD and brentuximab vedotin with HAART [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    The frequency of adverse events and their severity will be tabulated to evaluate tolerance of AVD and brentuximab vedotin with HAART.
  • Incidence of neurotoxicity in combination with HAART and AVD and brentuximab vedotin [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be tabulated. A binomial test of proportions will be used to test the difference in additional toxicity between those patients taking AVD and brentuximab vedotin on HAART vs. those patients not on HAART.
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Partial response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Partial response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Prognostic value of FDG-PET in patient with HIV and HL with respect to 2 year progression free survival [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.
  • Prognostic value of FDG-PET in patient with HIV and HL with respect to 2 year progression free survival [ Time Frame: 8 weeks (after 2 courses) ] [ Designated as safety issue: No ]
    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.
  • Prognostic value of FDG-PET in patient with HIV and HL with respect to 2 year progression free survival [ Time Frame: 24 weeks (end of treatment) ] [ Designated as safety issue: No ]
    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.
  • Viral load [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Repeated measures ANOVA models will be used to evaluate the effect of AVD and brentuximab vedotin on viral load after 1, 4, and 6 courses, and every 3 months after treatment completion for one year.
  • Frequency and severity of adverse events of AVD and brentuximab vedotin with HAART [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    The frequency of AEs and their severity will be tabulated to evaluate tolerance of AVD and brentuximab vedotin with HAART.
  • Partial response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Partial response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Complete response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Complete response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Binomial probabilities and their 95% confidence intervals will be used to estimate the response rates.
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.
  • Event-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.
  • Prognostic value of FDG-PET in patient with HIV and HL with respect to 2 year progression free survival [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 cycles and post-therapy in patients with HIV and HL with respect to progression free survival.
  • Prognostic value of FDG-PET in patient with HIV and HL with respect to 2 year progression free survival [ Time Frame: 8 weeks (after 2 courses) ] [ Designated as safety issue: No ]
    Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 cycles and post-therapy in patients with HIV and HL with respect to progression free survival.
  • Prognostic value of FDG-PET in patient with HIV and HL with respect to 2 year progression free survival [ Time Frame: 24 weeks (end of treatment) ] [ Designated as safety issue: No ]
    Log-rank analysis will be used to investigate the prognostic value of FDG-PET scans at baseline, after 2 cycles and post-therapy in patients with HIV and HL with respect to progression free survival.
  • HAART status [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Log-rank analysis will be used to evaluate HAART status at baseline for difference in outcome in terms of overall survival and progression free survival. The frequency and proportion of different histologic subtypes will be calculated.
  • Characterization of histologic subtypes in HIV-HL in the HAART era [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Incidence of neurotoxicity in combination with HAART and AVD and brentuximab vedotin [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be tabulated. A binomial test of proportions will be used to test the difference in additional toxicity between those patients taking AVD and brentuximab vedotin on HAART vs. those patients not on HAART.
  • Effect of AVD and brentuximab vedotin on viral load [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Repeated measures analysis of variance (ANOVA) models will be used to evaluate the effect of AVD and brentuximab vedotin on CD4 counts, CD8 counts and viral load after 1, 4, and 6 cycles, and every 3 months after treatment completion for one year.
Not Provided
Not Provided
 
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
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. Monoclonal antibodies, such as brentuximab vedotin, may block cancer growth in different ways by targeting certain cells. 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.

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 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 progression-free survival (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 courses 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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • AIDS-Related Hodgkin Lymphoma
  • Classical Hodgkin Lymphoma
  • HIV Infection
  • Stage IIA Hodgkin Lymphoma
  • Stage IIB Hodgkin Lymphoma
  • Stage IIIA Hodgkin Lymphoma
  • Stage IIIB Hodgkin Lymphoma
  • Stage IVA Hodgkin Lymphoma
  • Stage IVB Hodgkin Lymphoma
  • Drug: Brentuximab Vedotin
    Given IV
    Other Names:
    • ADC SGN-35
    • Adcetris
    • Anti-CD30 Antibody-Drug Conjugate SGN-35
    • Anti-CD30 Monoclonal Antibody-MMAE SGN-35
    • Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35
    • cAC10-vcMMAE
    • SGN-35
  • Drug: Dacarbazine
    Given IV
    Other Names:
    • 4-(Dimethyltriazeno)imidazole-5-carboxamide
    • 5-(Dimethyltriazeno)imidazole-4-carboxamide
    • Asercit
    • Biocarbazine
    • Dacarbazina
    • Dacarbazina Almirall
    • Dacarbazine - DTIC
    • Dacatic
    • Dakarbazin
    • Deticene
    • Detimedac
    • DIC
    • Dimethyl (triazeno) imidazolecarboxamide
    • Dimethyl Triazeno Imidazol Carboxamide
    • Dimethyl Triazeno Imidazole Carboxamide
    • dimethyl-triazeno-imidazole carboxamide
    • Dimethyl-triazeno-imidazole-carboximide
    • DTIC
    • DTIC-Dome
    • Fauldetic
    • Imidazole Carboxamide
    • Imidazole Carboxamide Dimethyltriazeno
    • WR-139007
  • Drug: Doxorubicin Hydrochloride
    Given IV
    Other Names:
    • 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)
    • ADM
    • Adriacin
    • Adriamycin
    • Adriamycin Hydrochloride
    • Adriamycin PFS
    • Adriamycin RDF
    • ADRIAMYCIN, HYDROCHLORIDE
    • Adriamycine
    • Adriblastina
    • Adriblastine
    • Adrimedac
    • Chloridrato de Doxorrubicina
    • DOX
    • DOXO-CELL
    • Doxolem
    • Doxorubicin.HCl
    • Doxorubin
    • Farmiblastina
    • FI 106
    • FI-106
    • hydroxydaunorubicin
    • Rubex
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Pharmacological Study
    Correlative studies
  • Drug: Vinblastine
    Given IV
    Other Names:
    • Vincaleucoblastine
    • VLB
Experimental: 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 courses in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: Brentuximab Vedotin
  • Drug: Dacarbazine
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study
  • Drug: Vinblastine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
June 2018   (final data collection date for primary outcome measure)

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 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

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) 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
  • Prior malignancy within 5 years of 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)
  • 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
Both
18 Years and older   (Adult, Senior)
No
United States,   France
 
NCT01771107
NCI-2013-00046, NCI-2013-00046, 085, 2014-003678-18, AMC-085, AMC-085, U01CA121947
Yes
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Paul Rubinstein AIDS Malignancy Consortium
National Cancer Institute (NCI)
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP