Clinical trial · Interventional
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma
Prospective Phase II Study of a High Dose, Short Course Regimen (R-CODOX-M/IVAC) Including CNS Penetration and Intensive IT Prophylaxis in HIV-Associated Burkitt's and Atypical Burkitt's Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed, HIV-associated Burkitt's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| liposomal cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen A (R-CODOX-M chemotherapy)
- description
- Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
- interventionNames
- Biological: filgrastim
- Biological: pegfilgrastim
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: doxorubicin hydrochloride
- Drug: leucovorin calcium
- Drug: liposomal cytarabine
- Drug: methotrexate
- Drug: therapeutic hydrocortisone
- Drug: vincristine sulfate
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed Burkitt's lymphoma (BL) or new WHO 2009 criteria B-cell lymphoma unclassified (with features intermediated between difuse large B-cell lymphoma and BL)
* Any stage disease
* Newly diagnosed disease
* Meets 1 of the following criteria for disease risk:
* Low-risk disease, defined by 1 of the following:
* Stage I with a single focus of disease \< 10 cm AND normal lactate dehydrogenase (LDH) level
* Totally resected intra-abdominal disease only AND normal LDH post surgery
* High-risk disease, defined as not meeting criteria for low-risk disease
* Measurable or nonmeasurable disease
* HIV-positive confirmed by enzyme-linked immunosorbent assay and Western blot OR by measurable HIV viral load
* No visceral Kaposi's sarcoma
PATIENT CHARACTERISTICS:
* Karnofsky performance status 40-100%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* LVEF ≥ 50% by MUGA or echocardiogram
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 50,000/mm³ (unless related to lymphoma)\*
* Direct bilirubin ≤ 2.0 mg/dL OR total bilirubin ≤ 3.5 mg/dL AND direct bilirubin normal (if elevated bilirubin secondary to antiretroviral therapy)
* AST and ALT ≤ 3 times upper limit of normal
* No other malignancy within the past 5 years except curatively treated cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or cutaneous Kaposi's sarcoma
* No other medical illness unrelated to non-Hodgkin's lymphoma, including any of the following:
* Uncontrolled infection (including opportunistic infection)
* Chronic renal insufficiency
* Myocardial infarction within the past 6 months
* Unstable angina
* Cardiac arrhythmias other than chronic atrial fibrillation
* Patients with active hepatitis B infection are eligible provided they receive concurrent dual antiviral therapy NOTE: \*Patients with bone marrow involvement are eligible irrespective of blood count
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior therapy for this disease except for 1 of the following :
* Seven consecutive days of steroids alone or in combination with a non-CHOP regimen necessary for patient stabilization (e.g., cyclophosphamide and steroids steroids for normalization of disease-related hyperbilirubinemia)
* One course of CHOP or fractionated CHOP (e.g. CODOX) with or without rituximab
* No epoetin alfa or filgrastim (G-CSF) within 24 hours of study chemotherapy
* No concurrent zidovudineReferences
Publications (1)
- RESULTNoy A, Lee JY, Cesarman E, Ambinder R, Baiocchi R, Reid E, Ratner L, Wagner-Johnston N, Kaplan L; AIDS Malignancy Consortium. AMC 048: modified CODOX-M/IVAC-rituximab is safe and effective for HIV-associated Burkitt lymphoma. Blood. 2015 Jul 9;126(2):160-6. doi: 10.1182/blood-2015-01-623900. Epub 2015 May 8. PMID 25957391