Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-03-08 @ 3:31 AM
Study NCT ID:
NCT05813132
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2023-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BeEAM Versus CEM in Lymphoma Patients as a Conditioning Regimen Before Autologous Hematopoietic Cell Transplantation
Sponsor:
Rehab Werida
Organization:
Study Overview
Official Title:
BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Versus CEM (Carboplatin, Etoposide, Melphalan) in Lymphoma Patients as a Conditioning Regimen Before Autologous Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: