LymphomaNCT05813132
BeEAM Versus CEM in Lymphoma Patients as a Conditioning Regimen Before Autologous Hematopoietic Cell Transplantation
A study testing BEAM Protocol and CEM protocol in people with Lymphoma, run by Rehab Werida at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- BEAM Protocol and CEM protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- BEAM Protocol, CEM protocol
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEAM ProtocolDrug
Also called (Bendamustine, Etoposide, Cytarabine, Melphalan
BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan)
CEM protocolDrug
Also called (Carboplatin, Etoposide, Melphalan)
CEM (Carboplatin, Etoposide, Melphalan)
| Study group | Role | What they receive |
|---|---|---|
| BeEAM Regimen | Active comparator | BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Receives: Drug: BEAM Protocol |
| CEM Regimen | Active comparator | CEM (Carboplatin, Etoposide, Melphalan) Receives: Drug: CEM protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Side Effects.
Side effects of treatment
Measured: 3 month
Secondary outcomes (1)
Concentration of CD34+
CD34+
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start11 Nov 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Noha A. El bassiouny, Lecturer, Study director, Damanhour UniversityMohamed Khalef, Ph.D, Study director, Maady Military HospitalMahmoud Abdallah, Ph.D., Study director, International Medical Center (IMC) Hospital, Cairo, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813132
- Sponsor's protocol ID
- BeEAM versus CEM in lymphoma
- Status last verified
- Sep 2024
- First submitted
- 16 Mar 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3334893Frankiewicz 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.
PubMed 30150889Eltelbanei 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.
PubMed 39134959
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Versus CEM (Carboplatin, Etoposide, Melphalan) in Lymphoma Patients as a Conditioning Regimen Before Autologous Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05813132
- Acronym / sponsor ID
- BeEAM versus CEM in lymphoma
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BeEAM Regimen | Active comparator | Drug: BEAM ProtocolBeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) |
| CEM Regimen | Active comparator | Drug: CEM protocolCEM (Carboplatin, Etoposide, Melphalan) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEAM ProtocolAlso: (Bendamustine, Etoposide, Cytarabine, MelphalanBeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) | Drug | BeEAM Regimen |
| CEM protocolAlso: (Carboplatin, Etoposide, Melphalan)CEM (Carboplatin, Etoposide, Melphalan) | Drug | CEM Regimen |
Primary outcome
Incidence of Side Effects.
Time frame: 3 month
Side effects of treatment
1 secondary outcome
Concentration of CD34+
Time frame: Three Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Results publication: PubMed 3334893Velasquez 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.
- Results publication: PubMed 30150889Frankiewicz 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.
- Derived from this study: PubMed 39134959Eltelbanei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noha A. El bassiouny, Lecturer study director
Damanhour University
Mohamed Khalef, Ph.D study director
Maady Military Hospital
Mahmoud Abdallah, Ph.D. study director
International Medical Center (IMC) Hospital, Cairo, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEAM Protocol and CEM protocol in people with Lymphoma, run by Rehab Werida at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Side Effects. (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05813132, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.