Phase 2 N=68 Treatment

EPOCH and Rituximab to Treat Non-Hodgkin's Lymphoma in Patients With HIV Infection

Lymphoma, AIDS-related · Lymphoma, Large B-Cell, Diffuse

Bottom Line

View on ClinicalTrials.gov: NCT00006436 ↗

Enrolled (actual)

Serious AEs

34.3%

Results posted

Jun 2022

Primary outcome: Primary: Median Progression Free Survival (PFS) — 13.8 years

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rituximab (Biological); Filgrastim (Biological); EPOCH (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Progression Free Survival (PFS)	13.8	—
PRIMARY Progression Free Survival at 1 Year	79.1	—
SECONDARY Number of Participants With ≥ Grades 3-5 Non-hematologic Toxicity	17; 0; 0; 0; 0; 0	—
SECONDARY Median Overall Survival	14.2	—
SECONDARY 1 Year Overall Survival	83.7	—
SECONDARY Median Duration of Complete Response/Complete Response Unconfirmed	13.9	—
SECONDARY Percentage of Participants With CR/CRu Lasting 1 Year	82.5	—
SECONDARY Number of Participants With at Least One Hematologic Toxicity Event of Febrile Neutropenia	18	—
SECONDARY Number of Cycles of Hematologic Toxicity	25; 112; 77; 40; 6; 36	—
SECONDARY Overall Response	53; 10; 1; 1; 1	—
SECONDARY Percentage of Participants With Complete Response	95	—
SECONDARY Median Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)	10.2; NA	0.10
SECONDARY 1 Year Interim Positron Emission Tomography (PET) Positive Progression Free Survival (PFS)	61.5; 89.3	—
SECONDARY Recovery of CD4 T Cells (CD4) Counts	2.5	—
SECONDARY Recovery of Human Immunodeficiency Virus (HIV) Viral Load	2	—

Summary

Background: * Human immunodeficiency virus (HIV)-infected patients have a weakened immune system, and chemotherapy, which is used to treat lymphoma, probably causes further damage to the immune system. * Limiting the amount of immune damage due to chemotherapy might decrease the number of infections and the risk of developing cancer in the future in HIV-infected patients with non-Hodgkin's lymphoma. Objectives: * To determine whether reducing the total amount of chemotherapy using a specific combination of drugs called EPOCH-R (etoposide, doxorubicin, vincristine, cyclophosphamide and rituximab) will rid the body of lymphoma quickly while decreasing the risk of infections and future cancers. * To determine whether the lymphoma will remain undetectable for at least one year if treatment is stopped one cycle after the patient enters remission. Eligibility: -Patients with non-Hodgkin's lymphoma and HIV infection 4 years of age and older who have not been treated previously with rituximab or cytotoxic chemotherapy. Design: * Patients receive EPOCH-R in 3-week treatment cycles for at least three and no more than six cycles. * The lymphoma is evaluated using computed tomography (CT) and positron emission tomography (PET) scans at the end of treatment cycles 2 and 3. A bone marrow biopsy is repeated after cycle 2 if a biopsy was initially positive on screening for participation in the study. * Anti-HIV therapy is stopped before chemotherapy begins and is restarted when EPOCH-R treatment ends. * Patients are monitored for treatment response with blood tests and imaging scans at baseline, when treatment ends, 2 months after treatment ends and then every 3 to 6 months for a total of 24 months following chemotherapy.

Eligibility Criteria

INCLUSION CRITERIA:

Aggressive B-lymphocyte antigen CD20 (CD20) positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, National Cancer Institute (NCI). Note: Participants with aggressive B-cell lymphoma of the plasmablastic lymphoma sub-type who do not have surface CD20 expression, are also eligible.

Human immunodeficiency virus (HIV) + serology.

All stages (I-IV) of disease.

Eastern Cooperative Oncology Group (ECOG) Performance status 0-4

Non-Hodgkin's Lymphoma (NHL) previously untreated with cytotoxic chemotherapy; however, participants may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g., epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture

Age greater than or equal to 18 years

Laboratory tests (unless impairment due to respective organ involvement by tumor):

Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min
Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in participants for whom these abnormalities are felt to be due to protease inhibitor therapy
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3x upper limit of normal (ULN) (AST and ALT less than or equal to 6x ULN for participants on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation)
Absolute neutrophil count (ANC) greater than or equal to 1000/mm(3)
Platelet greater than or equal to 75,000/mm(3) (unless impairment due to Immune thrombocytopenic purpura (ITP)

Ability of participant to provide informed consent.

EXCLUSION CRITERIA

Previous rituximab

Pregnancy or nursing.

Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk.

Current clinical heart failure or symptomatic ischemic heart disease.

Serious underlying medical condition or infection other than HIV that would contraindicate subcutaneous (SC)-rituximab, etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (hydroxydaunorubicin (EPOCH-R).

Examples include, but are not limited to:
Severe Acquired immunodeficiency syndrome (AIDS)-related wasting
Sever intractable diarrhea
Active inadequately treated opportunistic infection of the central nervous system (CNS)
Primary CNS lymphoma

Primary CNS lymphoma

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00006436). 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.