BeEAM Versus CEM in Lymphoma Patients as a Conditioning Regimen Before Autologous Hematopoietic Cell Transplantation

NCT05813132 | Completed DMC

• 1 other identifier: BeEAM versus CEM in lymphoma
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research aims to compare between BeEAM standard regimen and CEM as conditioning regimen in lymphoma patients in safety profile\& toxicity, infections (Febrile neutropenia) during transplant, time to engraftment (recovery not neutropenic), Length of stay at hospital, time to relapse, and other complications.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Side Effects.

  Side effects of treatment

  3 month

Secondary Outcomes (1)

• Concentration of CD34+

  Three Months

Study Arms (2)

BeEAM Regimen

ACTIVE COMPARATOR

BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan)

Drug: BEAM Protocol

CEM Regimen

ACTIVE COMPARATOR

CEM (Carboplatin, Etoposide, Melphalan)

Drug: CEM protocol

Interventions

BEAM Protocol DRUG

BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan)

Also known as: (Bendamustine, Etoposide, Cytarabine, Melphalan

BeEAM Regimen

CEM protocol DRUG

CEM (Carboplatin, Etoposide, Melphalan)

Also known as: (Carboplatin, Etoposide, Melphalan)

CEM Regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with lymphoma relapsed/refractory (RR) Hodgkin's lymphoma (HL) and non-Hodgkin lymphoma (NHL) with all subtypes. 2. Treat with conventional dose salvage regimens 3. Remission status before HSCT is complete remission (CR) or partial remission (PR).

You may not qualify if:

• Remission status before HSCT is non remission (NR) or progressive disease (PD).
• CD34+ count cells \<2 ×106 CD34+ cells/kg BW
• CNS lymphoma or solid tumor not included in population.
• Pregnancy or breast-feeding.
• Any Psychological, familial, sociological, or geographical factor that interfere with patient adherence to medications.
• History of allergy to any medications in both protocol

Sponsors & Collaborators

• Rehab Werida: lead

Study Sites (1)

International Medical Center (IMC) Hospital, Cairo, Egypt.

Cairo, Egypt

Location

Related Publications (3)

• Velasquez WS, Cabanillas F, Salvador P, McLaughlin P, Fridrik M, Tucker S, Jagannath S, Hagemeister FB, Redman JR, Swan F, et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood. 1988 Jan;71(1):117-22.

  PMID: 3334893 RESULT

• Frankiewicz A, Sadus-Wojciechowska M, Najda J, Czerw T, Mendrek W, Sobczyk-Kruszelnicka M, Soska K, Ociepa M, Holowiecki J, Giebel S. Comparable safety profile of BeEAM (bendamustine, etoposide, cytarabine, melphalan) and BEAM (carmustine, etoposide, cytarabine, melphalan) as conditioning before autologous haematopoietic cell transplantation. Contemp Oncol (Pozn). 2018;22(2):113-117. doi: 10.5114/wo.2018.77046. Epub 2018 Jun 30.

  PMID: 30150889 RESULT

• Eltelbanei MA, El-Bassiouny NA, Abdalla MS, Khalaf M, Werida RH. Clinical and safety outcomes of BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) versus CEM (Carboplatin, Etoposide, Melphalan) in lymphoma patients as a conditioning regimen before autologous hematopoietic cell transplantation. BMC Cancer. 2024 Aug 13;24(1):1002. doi: 10.1186/s12885-024-12694-9.

  PMID: 39134959 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

BEAM protocol; Bendamustine Hydrochloride; Etoposide; Cytarabine; Melphalan; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Coordination Complexes

Study Officials

• Noha A. El bassiouny, Lecturer

  Damanhour University

  STUDY DIRECTOR

• Mohamed Khalef, Ph.D

  Maady Military Hospital

  STUDY DIRECTOR

• Mahmoud Abdallah, Ph.D.

  International Medical Center (IMC) Hospital, Cairo, Egypt.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 14, 2023
• Study Start: November 11, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)