Clinical trial · Interventional
Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26)
- 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. 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 rituximab together with one of five different combination chemotherapy regimens may kill more cancer cells. PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse 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 (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin sulfate | Biological | Bleomycin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisolone
- Drug: vincristine sulfate
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: filgrastim
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary mediastinal diffuse large B-cell lymphoma * CD20-positive disease * Any stage of disease * Must have a dominant mass within the anterior mediastinum PATIENT CHARACTERISTICS: * ANC ≥ 1.5 x 10\^9/L (unless due to lymphoma) * Platelets ≥ 100 x 10\^9/L (unless due to lymphoma) * WBC ≥ 3.0 x 10\^9/L (unless due to lymphoma) * Serum creatinine ≤ 2 times upper limit of normal (ULN) (unless due to lymphoma) * AST/ALT ≤ 2.5 times ULN (unless due to lymphoma) * Total bilirubin ≤ 2.5 times ULN (unless due to lymphoma) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must be fit to receive chemotherapy with curative intent * No evidence of clinically significant cardiac disease\* within the past 12 months, including any of the following: * Symptomatic ventricular arrhythmias * Congestive heart failure * Myocardial infarction NOTE: \* Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease. * No known HIV infection * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * Able and willing to give informed consent and to undergo staging, including PET scanning PRIOR CONCURRENT THERAPY: * No prior treatment for lymphoma * Prior corticosteroids for up to 1 week allowed for the relief of local compressive symptoms
References
Publications (0)
Data not yet available