Clinical trial · Interventional
BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
A Phase II, Multicenter, Prospective, Non-randomised, Open-label, Clinical Trial to Evaluate Effectiveness and Safety of BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation
- 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)
Nowadays there is no randomized trials for comparison the effectiveness and tolerability of different conditioning regimens. Bendamustine is a unique chemotherapeutic agent that combines alkylating action of nitrogen mustard and the activity of purine antimetabolite. Bendamustine has shown its effectiveness for the treatment of patients with chronic lymphoproliferative diseases such as chronic lymphocytic leukemia and several indolent lymphomas. The literature also presents evidence of the effectiveness bendamustine in patients with Hodgkin's lymphoma who received multiple lines of prior chemotherapy, including high dose chemotherapy and transplantation of peripheral hematopoietic stem cells. There are also data of using bendamustine as a part of conditioning regimen. In this context, it was planned a study for evaluation the safety and effectiveness of the BeEAC (bendamustine, etoposide, cytarabine, cyclophosphamide) conditioning regimen prior to autologous transplantation of peripheral hematopoietic stem cells for the treatment of relapsed/refractory malignant lymphomas.
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 |
|---|---|---|---|
| Relapsed/Refractory Malignant Lymphomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Relapsed/refractory malignant lymphomas
- description
- Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen
- interventionNames
- Drug: Bendamustine
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- From admission till discharge from the hospital (approximately 30 days)
- description
- The primary safety analysis will be based on subjects who experienced toxicities as defined by CTCAE criteria. Safety will be assessed by quantifying the toxicities and grades experienced by subjects who have received BeEAC including serious adverse events (SAEs). Adverse experiences will be graded and recorded throughout the study and during the follow-up period according to NCI CTCAE 4.03. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading and action taking with regard to trial treatment (Incidence of Treatment-Emergent Adverse Events).
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial 2. Be ≥ 18 years of age on day of signing informed consent 3. Eastern Cooperative Oncology Group (ECOG) \< 2. 4. Relapsed/refractory malignant lymphoma patients with indications to autologous hematopoietic stem-cell transplantation Exclusion Criteria: 1. Participation in another clinical trials 2. Clinically relevant heart disease: * Myocardial infarction during previous 6 months * Unstable angina during previous 3 months * Congestive heart failure (III-IV NYHA) * Clinically relevant ventricular arrhythmias * corrected QT interval (QTc) \> 460 мс on ECG (calculated using Frederics formula) * Left ventricular ejection fraction ≤ 45% on Echocardiogram * Atrial Hypotension (systolic pressure \< 86 mmHg) or bradycardia (\< 50 per minute, exclusion - drug-induced bradycardia) * Uncontrolled arterial hypertension (systolic pressure \> 170 mmHg or diastolic pressure \> 105 mmHg) 3. Severe renal dysfunction (serum creatinine \> 250 µmol/l) 4. Severe hepatic dysfunction (total bilirubin \> 40 µmol/l) 5. Known history of Human Immunodeficiency Virus or active Hepatitis B and C 6. Psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial 7. Hypersensitivity to investigational drugs 8. Pregnant or breastfeeding females or males and females with childbearing potential must be willing to use an adequate method of birth control (intrauterine device, vasectomy of female subjects' male partner, contraceptive rod implanted into the skin, combination method - (requires use of two of the following) diaphragm with spermicide, cervical cap spermicide, contraceptive sponge, condom, hormonal contraceptive)
References
Publications (8)
- BACKGROUNDMartino M, Olivieri A, Offidani M, Vigna E, Moscato T, Fedele R, Montanari M, Console G, Gentile M, Messina G, Irrera G, Morabito F. Addressing the questions of tomorrow: melphalan and new combinations as conditioning regimens before autologous hematopoietic progenitor cell transplantation in multiple myeloma. Expert Opin Investig Drugs. 2013 May;22(5):619-34. doi: 10.1517/13543784.2013.788643. Epub 2013 Apr 4. PMID 23550793
- BACKGROUNDSchmitz N, Pfistner B, Sextro M, Sieber M, Carella AM, Haenel M, Boissevain F, Zschaber R, Muller P, Kirchner H, Lohri A, Decker S, Koch B, Hasenclever D, Goldstone AH, Diehl V; German Hodgkin's Lymphoma Study Group; Lymphoma Working Party of the European Group for Blood and Marrow Transplantation. Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial. Lancet. 2002 Jun 15;359(9323):2065-71. doi: 10.1016/S0140-6736(02)08938-9. PMID 12086759
- BACKGROUNDBlay J, Gomez F, Sebban C, Bachelot T, Biron P, Guglielmi C, Hagenbeek A, Somers R, Chauvin F, Philip T. The International Prognostic Index correlates to survival in patients with aggressive lymphoma in relapse: analysis of the PARMA trial. Parma Group. Blood. 1998 Nov 15;92(10):3562-8. PMID 9808548
- BACKGROUNDChen YB, Lane AA, Logan B, Zhu X, Akpek G, Aljurf M, Artz A, Bredeson CN, Cooke KR, Ho VT, Lazarus HM, Olsson R, Saber W, McCarthy P, Pasquini MC. Impact of conditioning regimen on outcomes for patients with lymphoma undergoing high-dose therapy with autologous hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2015 Jun;21(6):1046-1053. doi: 10.1016/j.bbmt.2015.02.005. Epub 2015 Feb 14. PMID 25687795
- BACKGROUNDFriedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008 Jan 10;26(2):204-10. doi: 10.1200/JCO.2007.12.5070.