Clinical trial · Interventional
Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
A Randomised Phase III Study On The Effect Of The Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) During Sequential Chemotherapy Followed By Autologous Stem Cell Transplantation In Patients With Relapse B-Cell Non-Hodgkin Lymphoma(HOVON 44 STUDY)
- 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 tumor cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known if giving more than one drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed 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 (13)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| carmustine | Drug | Carmustine | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (2)
- measure
- Response rate
- measure
- Event-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed relapsed B-cell non-Hodgkin's lymphoma (NHL) * Diffuse large cell B-cell lymphoma * Grade III follicular center-cell lymphoma * Primary mediastinal B-cell lymphoma * CD20 positive * First relapse after doxorubicin containing regimen * Documented remission of at least 3 months after first-line chemotherapy * No Epstein-Barr virus post-transplantation lymphoproliferative disorder * No CNS involvement PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No hepatic dysfunction * Bilirubin less than 2.5 times upper limit of normal (ULN) * Transaminases less than 2.5 times ULN Renal: * No renal dysfunction * Creatinine less than 2.0 mg/dL OR * Creatinine clearance greater than 40 mL/min Cardiovascular: * No severe cardiac dysfunction * No New York Heart association class II-IV heart disease Pulmonary: * No severe pulmonary dysfunction * Vital capacity or diffusion capacity at least 70% predicted unless related to NHL involvement Other: * No active uncontrolled infection * HIV negative * No intolerance to exogenous protein administration PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 month since prior immunotherapy Chemotherapy: * See Disease Characteristics * At least 1 month since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 1 month since prior radiotherapy Surgery: * Not specified
References
Publications (1)
- RESULTVellenga E, van Putten WL, van 't Veer MB, Zijlstra JM, Fibbe WE, van Oers MH, Verdonck LF, Wijermans PW, van Imhoff GW, Lugtenburg PJ, Huijgens PC. Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL: a prospective randomized HOVON trial. Blood. 2008 Jan 15;111(2):537-43. doi: 10.1182/blood-2007-08-108415. Epub 2007 Oct 30. PMID 17971487