Clinical trial · Interventional
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell 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, such as liposomal doxorubicin, 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 liposomal doxorubicin may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin'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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1: Rituximab and Doxorubicin HCI Liposome
- description
- Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
- interventionNames
- Biological: rituximab
- Drug: pegylated liposomal doxorubicin hydrochloride
Primary outcomes (1)
- measure
- Complete Response Rate at 20 Weeks
- timeFrame
- 20 weeks
- description
- Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes \> 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following indolent or aggressive B-cell non-Hodgkin's lymphoma (NHL) subtypes: * Grade 1-3 follicular lymphoma * Mantle cell lymphoma * Small lymphocytic lymphoma * Diffuse large B-cell lymphoma * Diffuse mixed cell lymphoma * Marginal zone lymphoma * Relapsed or refractory CD20-positive disease * Measurable disease * Must have received ≥ 1 but \< 4 prior standard chemotherapy regimens * No Burkitt's lymphoma or precursor B-lymphoblastic lymphoma * No CNS lymphoma PATIENT CHARACTERISTICS: Performance status * Karnofsky 60-100% Life expectancy * At least 6 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin \> 7 g/dL Hepatic * AST or ALT \< 2 times upper limit of normal (unless due to primary disease) * Bilirubin ≤ 2 mg/dL Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * LVEF ≥ 50% by MUGA and/or 2-D echocardiogram * No history of New York Heart Association class II-IV cardiac disease * No congestive heart failure Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known HIV positivity * No uncontrolled active bacterial, viral, or fungal infection * No other serious disease that would preclude study participation * No other primary malignancy within the past 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Recovered from prior immunotherapy * Prior immunotherapy, including rituximab or other monoclonal antibody, allowed Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy and recovered * No prior doxorubicin (or equivalent anthracycline) at a cumulative dose \> 400 mg/m\^2 * No other concurrent chemotherapy Endocrine therapy * Nonsteroidal hormones for nonlymphoma-related conditions (e.g., insulin for diabetes) allowed * No concurrent corticosteroids except for a transient inflammatory reaction (i.e., skin rash or hives) Radiotherapy * Recovered from prior radiotherapy * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery (other than diagnostic surgery) and recovered Other * No other concurrent antitumor agents * No other concurrent investigational agents
References
Publications (0)
Data not yet available