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

January 18, 2024 updated by: Rehab Werida

BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Versus CEM (Carboplatin, Etoposide, Melphalan) in Lymphoma Patients as a Conditioning Regimen Before Autologous Hematopoietic Cell Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. All patients' history will be confirmed diagnosis of lymphoma subtype under microscope to When an abnormal cell called a Reed-Sternberg cell is present, the lymphoma is classified as Hodgkin if not so it is NHL Which has another subtype by phenotyping.
  2. All patient will be confirmed in CR or PR before transplant was assessed by 18-FDG PET-CT imaging.

  3. All patients will be mobilized by using G-CSF agent (filgrastim)

    • plerixafor
  4. Check cluster of differentiation 34 (CD34+) count as Hematopoietic stem cell (HSCs) graft is mainly determined by the number of CD34+ cells present. the minimal number of CD34+ cells for an autologous transplant (Cutoff point) is <2 ×106 CD34+ cells/kg BW. Stem cell collection with target yield of 2-5 x 106 CD34 cells/kg (preferred) (13)
  5. Collect HSCs from the patient prior to receipt of high-dose chemotherapy by Leukapheresis through central line on one or two sessions.
  6. According to protocol of chemotherapy if BeEAM protocol, cells put in the final product includes 5-10% dimethyl sulfoxide (DMSO) as a cryoprotectant and 0.05-0.25" mL of ACD-A stabilizer solution per ml of transplant. Freezing at a controlled rate of 1-2"°C per minute if CME protocol cells will be mix with ACD and freezing (fresh cells).

  7. All enrolled patients (50) will be randomly assigned into two equal arms:

    Arm A : will receive BeEAM regimen : Bendamustine on day

    • 7 and -6 dose of 160-200 mg/m2/day IV in a 2-h infusion, Etoposide 150-200 mg/m2/day BID infusion on 30 min with 500 ml NaCl 0.9% on days -5 to -2, cytarabine 200 mg/m2/d IV BID in a 30-min infusion with 500 ml NaCl 0.9% on days -5 to -2, and melphalan 140 mg/m2 IV in a single 1-h 500 ml infusion with 0.9% NaCl on day -1(12)

    Arm B: will receive CME regimen: Carboplatin 25m/kg for day-2 and -1 in a 1hr infusion, Melphalan 140mg/m2 for day-2 and -1 in a 30 min infusion, Etoposide 30m/kg for day-2 and -1 in 2-3 hr.

  8. All patients received granulocyte - colony stimulating factor (G-CSF) at 5 ug/kg BW. starting from day +4 after AHSCT until absolute neutrophil count reached 1.5 × 109/l for two consecutive days. All patients received antiviral (oral acyclovir), antifungal (Oral fluconazole), and antibacterial (oral levofloxacin) prophylaxis. Since the start of conditioning until patient not neutropenic (Count reached 0.5 × 109/l), hyperuricemia prophylaxis was given (Oral allopurinol 100 mg TID), hepatic veno-occlusive disease prophylaxis enoxaparin sc daily until platelet > 25000/mm3 and ursodeoxycholic acid.

    transfusion of platelets or red blood cells was given when platelet count was lower than 20 × 109/l or hemoglobin level was lower than 80 g/l, respectively.

  9. Monitoring for any possible side effects:
  10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

1. 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).

4. Age>18 years. 5. Gender male and female. 6. CD34+ count cells <2 ×106 CD34+ cells/kg BW. Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BeEAM Regimen
BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan)
Drug: BEAM Protocol
BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan)
Other Names:
  • (Bendamustine, Etoposide, Cytarabine, Melphalan
Active Comparator: CEM Regimen
CEM (Carboplatin, Etoposide, Melphalan)
Drug: CEM protocol
CEM (Carboplatin, Etoposide, Melphalan)
Other Names:
  • (Carboplatin, Etoposide, Melphalan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Side Effects.
Time Frame: 3 month
Side effects of treatment
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of CD34+
Time Frame: Three Months
CD34+
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehab Werida

Investigators

  • Study Director: 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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

April 1, 2023

First Posted (Actual)

April 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeEAM versus CEM in lymphoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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