Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lymphoma

Acquired Immunodeficiency Syndrome

HIV Infections

Lymphoma, AIDS-Related

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, B-Cell

Lymphosarcoma

Lymphoma AIDS Related

Primary Effusion Lymphoma

B-cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Antineoplastic Agents, Immunological

Immunologic Factors

rituximab

CHOP

Francois Boue, MD

Dominique Costagliola

Most treatment procedures in AIDS-related lymphomas disclose a relatively poor outcome for patients with low response rates, high number of relapses and AIDS events. The addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients. The aim of the trial is to evaluate the safety and efficacy of rituximab when added to the CHOP regimen in patients with newly diagnosed AIDS-related non-Hodgkin lymphoma.

HIV infection is associated with a high incidence of AIDS-related lymphomas (ARL). Since the use of highly active antiretroviral therapy (HAART), the incidence of AIDS-defining illnesses has decreased, leading to a significant improvement in survival of HIV-infected patients. The incidence of ARL has decreased in a lower degree and lymphoma remains the major cause of death of HIV patients. Most treatment procedures disclose a relatively poor outcome of patients with low response rates, high number of relapses and AIDS events. Since the majority of HIV-associated NHL are CD20-positive the addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients

Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma

Multicenter, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab + CHOP Regimen in Patients With HIV Related Non-Hodgkin's Lymphomas. ANRS 085 Rituximab

Hoffmann-La Roche

French National Agency for Research on AIDS and Viral Hepatitis

Primary Central Nervous System Lymphoma

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Methotrexate

Anti-Retroviral Agents

Retrospective survival analysis

This study aims at describing survival rates over time (Kaplan-Meier estimator) in patients suffering from AIDS-related primary central nervous system lymphoma who were diagnosed from 1996 to 2014 and treated with infusions of high-dose methotrexate and combined antiretroviral therapy.

Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy

Fondation Ophtalmologique Adolphe de Rothschild

Symptoms and General Pathology

Digestive System Diseases

Uterine Cervical Neoplasms

Communicable Diseases

Sarcoma

Sarcoma, Kaposi

Anus Neoplasms

Neoplasms, Connective and Soft Tissue

Virus Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Herpesviridae Infections

DNA Virus Infections

Neoplasms, Vascular Tissue

Soft Tissue Sarcoma

Kaposi Sarcoma

Anal Cancer

Considering or currently receiving cancer treatment

This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.

Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.

Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.

Non-Interventional

Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.

Non-Interventional Follow-up

Anna E Coghill, PhD, MPH

Jayamalee De Silva, MD

Erin Reid, MD

Richard Lush

Sharad Goyal, MD

Kristina Bowles

Anna Coghill, MD

Richard Shi

Paul Rubinstein, MD

Laura Clark

Richard Ambinder, MD

Lee Ratner, MD, PhD

Jill Salvi

Rafi Kabaritti, MD

Keith Siegel, MD

Lisa Brenner

Gretchen McNally, APRN, CNP

Maggie Houchen

Elizabeth Chiao, MD, MPH

Marina Jovic

David Aboulafia, MD

This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.

Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC

Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AIDS Malignancy Consortium A Trial of the AIDS Malignancy Consortium (AMC)

The distribution of participant characteristics will be summarized. Continuous variables \[e.g. age, height, weight\] will be summarized as mean (std) if they are normally distributed, otherwise they will be summarized as median (IQR). Categorical variables \[e.g. tobacco use, ART medications, comorbidities\] will be summarized as frequency (%).

EORTC QLQ-C30 subscale and overall scores will be used to describe participant symptom and health-related quality of life burden. Baseline EORTC QLQ-C30 scores will be compared according to successful enrollment versus not. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and single items assessing additional symptoms and perceived financial impact of the disease. Most questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.

Supportive Care Needs Survey Short Form 34 \[SCNS-SF34\] scores will be used to categorize participants based on the degree to which their needs are met. Baseline SCNS-SF34 scores will be compared according to successful enrollment versus not. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need); with a higher score indicating a higher level of need.

EORTC QLQ-C30 will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.

Supportive Care Needs Short Survey Form 34 \[SCNS-SF34\] scores will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in scores will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The SCNS-SF34 is a 34-item questionnaire measuring the supportive care need and level of need for people diagnosed with cancer in the last month. It incorporates the underlying domains: physical and daily living, psychological, sexuality and health system, information and patient support. All the questions use 5-point scale (1 'Not applicable' to 5 'High need). Scores are averaged, and transformed to 0-100 scale;, with a higher score indicating a higher level of need.

The frequency of planned cancer treatment regimens (at baseline) successfully initiated will be summarized.

For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study:

1. Solid organ tumors associated with human papillomavirus (HPV) infection
2. Solid organ tumors unrelated to HPV
3. Kaposi sarcoma
4. Hematologic malignancies

This will be calculated by the number of participants enrolled who meet site-based AMC trial eligibility compared to the number of eligible participants at each site who meet site-based AMC trial eligibility.

National Cancer Institute (NCI)

AIDS Malignancy Consortium

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma	NCT00126243	AIDS Related Ly...	rituximab CHOP	18 Years - 75 Years	French National Agency for Research on AIDS and Viral Hepatitis
Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy	NCT03690895	Central Nervous... AIDS Related Ly...	Retrospective s...	18 Years -	Fondation Ophtalmologique Adolphe de Rothschild
Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy	NCT03690895	Central Nervous... AIDS Related Ly...	Retrospective s...	18 Years -	Fondation Ophtalmologique Adolphe de Rothschild
Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC	NCT05510908	HIV-Associated ... HIV Infections Cancer AIDS Related Ly... AIDS-related Ka... AIDS-Related Ma... Anal Cancer HPV-Related Mal...	Non-Interventio... Non-Interventio...	18 Years -	AIDS Malignancy Consortium
Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma	NCT00126243	AIDS Related Ly...	rituximab CHOP	18 Years - 75 Years	French National Agency for Research on AIDS and Viral Hepatitis

Spots Global Cancer Trial Database for aids related lymphoma