BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation

Phase 2

• Conditions: Relapsed/Refractory Malignant Lymphomas
• Interventions: Drug: Bendamustine

• Registration Number: NCT03315520
• Lead Sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-22
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-22
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relapsed/refractory malignant lymphomas	Bendamustine	Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation using BeEAC (Bendamustine, Cytarabine, Etoposide, Cyclophosphamide) conditioning regimen

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	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).

Secondary Outcome Measures

Name	Time	Method
Retrospective Comparison of Overall Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens	2 years	The analysis will be based on comparison of overall survival between different conditioning regimens
Progression-Free Survival	2 years
Overall Survival	2 years
Retrospective Comparison of Progression-Free Survival between Carmustine, Etoposide, Cytarabine, Melphalan (BEAM), Cyclophosphamide, Carmustine, Etoposide(CBV) and BeEAC conditioning regimens	2 years	The analysis will be based on comparison of Progression-Free survival between different conditioning regimens

Trial Locations

Locations (1)

The Federal Budget-Funded Institution National Medical Surgical Center named after N. I. Pirogov of the Ministry of health of the Russian Federation; 🇷🇺 Moscow, Russian Federation