Status and phase
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About
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.
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Inclusion criteria
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Participation in another clinical trials
Clinically relevant heart disease:
Severe renal dysfunction (serum creatinine > 250 µmol/l)
Severe hepatic dysfunction (total bilirubin > 40 µmol/l)
Known history of Human Immunodeficiency Virus or active Hepatitis B and C
Psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial
Hypersensitivity to investigational drugs
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)
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Central trial contact
Nikita Mochkin, MD, PhD; Vladislav Sarzhevskiy, MD, PhD
Data sourced from clinicaltrials.gov
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