Clinical trial · Interventional
Rituximab and Combination Chemotherapy With or Without Bleomycin Sulfate in Treating Patients With Primary Mediastinal Large B-Cell Lymphoma
A Randomized Phase II Study of Dose-Adjusted EPOCH-R and R-VACOP-B in Primary Mediastinal (Thymic) Large B-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate Accrual
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. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating large B-cell lymphoma. PURPOSE: This randomized phase II trial is studying how well rituximab and combination chemotherapy work when given with or without bleomycin sulfate in treating patients with primary mediastinal large B-cell 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| EPOCH regimen | Drug | — | UNRESOLVED |
| etoposide | Drug | Etoposide | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (EPOCH-R)
- description
- Patients receive rituximab IV on day 1; etoposide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV continuously over 96 hours on days 1-4; cyclophosphamide IV over 30 minutes on day 5; and oral prednisone twice daily on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: rituximab
- Drug: EPOCH regimen
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: prednisone
- Drug: vincristine sulfate
- type
- EXPERIMENTAL
- label
- Arm II (R-VACOP-B)
- description
- Patients receive rituximab IV and doxorubicin hydrochloride IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; cyclophosphamide IV over 30 minutes on day 1 of weeks 1, 5, and 9; etoposide IV over 1 hour on day 1 and then orally on days 2 and 3 of weeks 3, 7, and 11; bleomycin sulfate IV and vincristine sulfate IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; and oral prednisone on days 1-7 of week 1 and then every other day in weeks 2-10.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary mediastinal (thymic) large B-cell lymphoma as defined by WHO classification of lymphoid neoplasms * Diagnosis must be based on an adequate tissue sample, such as an excisional biopsy or core-needle biopsy * A paraffin-embedded block of well-fixed lymphoma tissue must be available * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 10 mm * No active or untreated CNS lymphoma * A lumbar puncture is not required in the absence of neurologic symptoms PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * ANC ≥ 1,000/mm\^3 (unless related to disease) * Platelet count ≥ 100,000/mm\^3 (unless related to disease) * Total bilirubin ≤ 2.0 times upper limit of normal (ULN) * AST and/or ALT ≤ 2.5 times ULN * Creatinine ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Ejection fraction ≥ 45% by MUGA or echocardiogram * Patients with HIV infection are eligible, provided the following criteria are met: * No evidence of co-infection with hepatitis B or C * CD4 cell count ≥ 400/mm\^3 * No evidence of resistant strains of HIV * HIV viral load ≤ 10,000 copies HIV RNA/mL (if not on anti-HIV therapy) * HIV viral load ≤ 50 copies HIV RNA/mL (if on anti-HIV therapy) * No history of AIDS-defining conditions * No concurrent uncontrolled illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situation that would limit compliance with study requirements * No active secondary malignancy except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: * No prior cytotoxic chemotherapy or rituximab * Prior limited course of glucocorticoids allowed * No other concurrent investigational or commercial anticancer therapies
References
Publications (0)
Data not yet available