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

Sponsor

Rehab Werida (Other)

Overall Status

Recruiting

CT.gov ID

NCT05813132

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: BEAM Protocol Drug: CEM protocol	N/A

Detailed Description

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.
All patient will be confirmed in CR or PR before transplant was assessed by 18-FDG PET-CT imaging.
All patients will be mobilized by using G-CSF agent (filgrastim)

plerixafor

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)
Collect HSCs from the patient prior to receipt of high-dose chemotherapy by Leukapheresis through central line on one or two sessions.
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).
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.

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Incidence of Side Effects. [3 month]
Side effects of treatment

Secondary Outcome Measures

Concentration of CD34+ [Three Months]
CD34+

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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