Phase 2
N=7
Intravenous Chemotherapy or Oral Chemotherapy in Treating Patients With Previously Untreated Stage III-IV HIV-Associated Non-Hodgkin Lymphoma
AIDS-related Diffuse Large Cell Lymphoma · AIDS-related Diffuse Mixed Cell Lymphoma · AIDS-related Diffuse Small Cleaved Cell Lymphoma · AIDS-related Immunoblastic Large Cell Lymphoma · AIDS-related Lymphoblastic Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01775475 ↗Enrolled (actual)
7
Serious AEs
100.0%
Results posted
Oct 2022
Primary outcome: Primary: Overall Survival — 0; 0 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cyclophosphamide (Drug); doxorubicin hydrochloride (Drug); vincristine sulfate (Drug); prednisone (Drug); lomustine (Drug); etoposide (Drug); procarbazine hydrochloride (Drug); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
0; 0 | — |
| PRIMARY Overall Response Rate |
3; 1 | — |
| PRIMARY Progression-free Survival |
0; 0 | — |
| PRIMARY Participants Who Experienced an Adverse Event |
4; 3 | — |
| PRIMARY Number of Patients Who Complete Treatment |
3; 1 | — |
| PRIMARY Proportion of Patients Who Are Adherent to Antiretroviral Therapy |
3; 3 | — |
| PRIMARY Proportion of Patients Who Are Adherent to Chemotherapy |
4; 3 | — |
| PRIMARY Change in Absolute CD4 Count From Baseline to Post-treatment |
-41.3; 203.3 | — |
Summary
This randomized phase II trial studies how well intravenous (IV) chemotherapy or oral chemotherapy works in treating patients with previously untreated stage III-IV human immunodeficiency virus (HIV)-associated non-Hodgkin lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, lomustine, etoposide, and procarbazine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells
Eligibility Criteria
Inclusion Criteria
- Ability to understand and the willingness to provide written informed consent to participate
- Adults, 18 years of age or older; date of birth should be determined based on the best possible information or source documentation available
- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or confirmed by HIV-1 antigen or plasma HIV-1 ribonucleic acid (RNA) viral load > 1,000 copies/mL
- NOTE: the term "licensed" refers to a United States (U.S.) Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally
- WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load
- Biopsy-proven, measurable or assessable systemic NHL that has been confirmed by an AIDS Malignancy Clinical Trial Consortium (AMC)-approved site pathologist; if a hard copy of the pathology report is unavailable at the time of enrollment, a verbal report by the pathologist confirming the diagnosis must be documented in the medical chart
- Pathology slides from tumor tissue obtained by surgical excision or core biopsy must be reviewed by the designated site pathologist, or backup pathologist, prior to study entry; confirmation of the diagnosis must be documented by the AMC-approved pathologist prior to study entry; please reference the AMC-068 Manual of Procedures (MOP) for further instructions on documenting the diagnosis; the site pathologist for NHL must be approved through the AMC's external quality assessment (EQA) process
- Participants must have fifteen blank(unstained) slides or a diagnostic tissue block must be available for central pathology review by the AMC Core Pathology Laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Participants must have an estimated life expectancy of > 6 weeks
- White blood cells (WBC) >= 3, 000 cells/uL (3.0 x 10^9 L) or
- Absolute granulocytes >= 1500 cells/uL (1.5 x 10^9 L)
- Platelets >= 100, 000 cells/uL (75 x 10^9 L)
- Hemoglobin > 8 g/dL (5.0 mmol/L)
- Patients may enroll with lower hematologic values, if bone marrow involvement is documented; in this case, patients should be transfused to hemoglobin > 8 g/dL
- Serum creatinine 1.2 mg/dL (20.5 uM/L)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 400 copies/mL who have been on antiretroviral therapy for more than 4 months can be enrolled if an alternative antiretroviral therapy (ART) regimen is available that includes at least two ART drugs that, in the opinion of the site investigator, are expected to have activity based on genotypic testing (if available) and treatment history; patients are not allowed to receive zidovudine (azidothymidine [AZT]) as part of concurrent chemotherapy and ART regimen, since it is myelosuppressive; zidovudine may be discontinued and substituted as clinically indicated prior to or at the time of enrollment.
- Participants of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a pregnancy test within 7 days prior to enrollm
Data sourced from ClinicalTrials.gov (NCT01775475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.