Clinical trial · Interventional
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
Phase II Study of Intensified CVP, Rituximab, and High Dose Cyclophosphamide for Adult Burkitt or Burkitt-Like 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: 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 more than one drug (combination chemotherapy) may kill more cancer cells. 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. Giving combination chemotherapy together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Hydrocortisone | Drug | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
| Vincristine |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R-CVP + HiCy
- description
- Protocol intervention consists of two fifteen-day cycles of cyclophosphamide (Cy), vincristine (V), prednisone (P), rituximab (R), with filgrastim support. CNS intervention consists of three days of cytarabine and hydrocortisone and one day of methotrexate (with leucovorin support) for each cycle. After those two cycles, rituximab and high-dose cyclophosphamide (HiCy) will be given.
- interventionNames
- Biological: Filgrastim
- Biological: Rituximab
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Methotrexate
- Drug: Prednisone
- Drug: Hydrocortisone
- Drug: Vincristine
- Drug: Leucovorin
Primary outcomes (4)
- measure
- Overall Response Rate
- timeFrame
- Up to 3 months
- description
- Number of participants who have a complete or partial remission (2007 International Working Group criteria).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Classic, sporadic Burkitt's lymphoma
* Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia)
* Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following criteria:
* Characteristic morphologic features
* High proliferative index AND Ki-67 ≥ 85%
* Any stage allowed
* Newly diagnosed or untreated disease
* Steroids allowed
PATIENT CHARACTERISTICS:
Age
* 30 and over
Performance status
* Not specified
Life expectancy
* Not specified
Renal
* No known irreversible renal dysfunction that would preclude treatment with high-dose cyclophosphamide
Cardiovascular
* No known significant cardiac dysfunction that would preclude treatment with high-dose cyclophosphamide
Other
* Not pregnant or nursing
* No known HIV positivity
* No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for lymphoma
* A maximum of 2 prior doses of intrathecal chemotherapy are allowed
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiation therapy for lymphoma
Surgery
* Prior complete or incomplete surgical resection of lymphoma allowedReferences
Publications (1)
- RESULTKasamon YL, Brodsky RA, Borowitz MJ, Ambinder RF, Crilley PA, Cho SY, Tsai HL, Smith BD, Gladstone DE, Carraway HE, Huff CA, Matsui WH, Bolanos-Meade J, Jones RJ, Swinnen LJ. Brief intensive therapy for older adults with newly diagnosed Burkitt or atypical Burkitt lymphoma/leukemia. Leuk Lymphoma. 2013 Mar;54(3):483-90. doi: 10.3109/10428194.2012.715346. Epub 2012 Aug 17. PMID 22835045