Clinical trial · Interventional
Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL
- 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 such as epirubicin use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining epirubicin with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed B-cell non-Hodgkin's lymphoma (any grade) or chronic lymphocytic leukemia meeting 1 of the following criteria:
* Primary refractory disease
* Disease progression after at least 1 but no more than 4 prior cytotoxic chemotherapy regimens
* Rituximab administered alone is not considered 1 prior regimen
* High-dose chemotherapy with stem cell support is considered 1 prior regimen
* Bidimensionally measurable or evaluable disease outside prior irradiation port
* No clinical evidence of CNS involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 2,000/mm\^3\*
* Platelet count at least 100,000/mm\^3\* NOTE: \*Unless due to bone marrow involvement
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
Renal
* Creatinine no greater than 2 times ULN
Cardiovascular
* No unstable angina
* No uncontrolled congestive heart failure
* LVEF at least 45%
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study treatment
* HIV negative
* No other concurrent primary malignancy except basal cell or squamous cell skin cancer, carcinoma in situ, or localized solid tumors cured more than 5 years ago
* No acute infection requiring systemic therapy
* No confusion, disorientation, or major psychiatric illness that would preclude understanding of informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 4 weeks since prior biologic therapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* Prior cumulative doxorubicin dose no greater than 6 courses at 50 mg/m\^2
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy to the entire pelvis
* At least 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* More than 7 days since prior cimetidine
* No concurrent cimetidineReferences
Publications (0)
Data not yet available