BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation (BeEAC-1)
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|ClinicalTrials.gov Identifier: NCT03315520|
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : May 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Malignant Lymphomas||Drug: Bendamustine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 22, 2016|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Relapsed/refractory malignant lymphomas
Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen
BeEAC conditioning regimen:
bendamustine 200 mg/м2 D-6 - D-5; cytarabine 400 mg/м2 D-4 - D-1; etoposide 400 mg/м2 D-4 - D-1; cyclophosphamide 140 mg/м2 totally, divided in 4 days (D-4 - D-1)
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: From admission till discharge from the hospital (approximately 30 days) ]
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).
- Overall Survival [ Time Frame: 2 years ]
- Progression-Free Survival [ Time Frame: 2 years ]
- Retrospective Comparison of Overall Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens [ Time Frame: 2 years ]The analysis will be based on comparison of overall survival between different conditioning regimens
- Retrospective Comparison of Progression-Free Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens [ Time Frame: 2 years ]The analysis will be based on comparison of Progression-Free survival between different conditioning regimens
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315520
|Contact: Vladislav Sarzhevskiy, MD, PhDemail@example.com|
|Contact: Nikita Mochkin, MD, PhDfirstname.lastname@example.org|
|The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation||Recruiting|
|Moscow, Russian Federation, 105203|
|Contact: Vladislav Sarzhevskiy, MD, PhD +74956037217 email@example.com|
|Contact: Nikita Mochkin, MD, PhD +74956037217 firstname.lastname@example.org|
|Principal Investigator:||Vladislav Sarzhevskiy, MD, PhD|