Large B Cell LymphomaPhase 2NCT03188198
Risk Adapted Therapy in Diffuse Large B Cell Lymphoma
A Phase 2 study testing rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim in people with Large B Cell Lymphoma, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Large B Cell Lymphoma
- What is being tested?
- rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2016to 1 Jun 2019
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease.
- Stage I primary mediastinal (thymic) DLBCL is also eligible. Diagnosis should be based on an adequate tissue sample, including open biopsy or core needle biopsy.
- Needle aspiration for primary diagnosis is unacceptable.
- Patients must have one of the following WHO classification subtypes:
- Diffuse large B-cell lymphoma (includes morphological variants: centroblastic, immunoblastic, T-cell/histiocyte rich, and anaplastic) Mediastinal (thymic) large B-cell lymphoma Intravascular large B-cell lymphoma Patients without adequate frozen material should have a biopsy performed to obtain material.
- 2. Patients may be entered if they have received prior limited field radiation therapy or a short course of glucocorticoids (< 10 days) for an urgent local disease complication at diagnosis (e.g., cord compression, SVC syndrome).
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- 3. Age >16 years old. 4. ECOG Performance Status 0-2 5. If there is suspicion of cardiac disease, a cardiac ejection fraction must show LVEF > 45%.
- 6. Required Initial Laboratory Values (unless non-Hodgkin lymphoma):
- ANC ≥ 1000/μL
- Platelets ≥ 100,000/μL
- Creatinine≤ 1.5 mg/dL or creatinine clearance ≥ 50 cc/min
- Total Bilirubin ≤ 2 mg/dL (unless a history of Gilbert's Disease)
Who cannot join
- 1- Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or low-grade lymphoma in the bone marrow, are not eligible.
- 2- Patients with low international prognostic index are not eligible. 3- Prior cytotoxic chemotherapy or rituximab. Patients who have received chemotherapy for prior malignancies are not eligible.
- 4- Active ischemic heart disease or congestive heart failure. 5- Known lymphomatous involvement of the CNS. A lumbar puncture prior to study is not required in the absence of neurological symptoms.
- 6- Known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible.
- 7- Pregnant and non-nursing. Treatment would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective form of contraception.
- 8- Patients with active medical processes (e.g., uncontrolled bacterial or viral infection, bleeding) not related to their lymphoma should be excluded.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Oncology center
Al Mansurah
Ahmed Eltantawy, Master, 00201091203484, eltantawy.ahmed1@gmail.com
About this study
Official title: Phase II Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R in Untreated De Novo Diffuse Large B-Cell Lymphomas
This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.
Read the detailed description
objectives:
- To compare the response rates and toxicity of R-CHOP versus DA-EPOCH-R in untreated CD20+ diffuse large B-cell lymphomas.
- To compare the event-free survival of R-CHOP versus DA-EPOCH-R chemotherapy in untreated CD20+ diffuse large B-cell lymphomas.
- To develop predictors of outcome of R-CHOP and DA-EPOCH-R chemotherapy.
- Conditions
- Large B Cell Lymphoma
- Being tested
- rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastimDrug
Also called rituximab:mabthera, etoposide:vepsid, cyclophosphamide:endoxan, doxorubcin:adriamycin
| Study group | Role | What they receive |
|---|---|---|
| Arm A - R-CHOP | Active comparator | Patients receive the following treatment:Rituximab 375 mg/m2 IV infusion on Day 1 prior to CHOP chemotherapy.Cyclophosphamide 750 mg/m^2 IV on Day 1.Doxorubicin 50 mg/m^2 IV on Day 1.Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1.Prednisone 40 mg/m^2/day PO on Days 1-5.filgrastim or pegfilgrastim as defined in the protocol Required ancillary medications is administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6.
Interventions:-Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: filgrastim-Drug: pegfilgrastim Receives: Drug: rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim |
| Arm B - DA-EPOCH-R | Experimental | Patients receive the following treatment: Cycle 1 Doses:Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy. Doxorubicin 10 mg/m^2/day CIVI on Days 1-4.Etoposide 50 mg/m^2/day CIVI on Days 1-4. Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours). Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions). Prednisone 60 mg/m^2 PO BID on Days 1-5 Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the nadir (nadir usually between Days 10-12) Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6.
Interventions:
-Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: etoposide-Drug: filgrastim Receives: Drug: rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: one year post-registration
Secondary outcomes (1)
Event-free survival
Measured: Up to 3 years post-registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Jun 2016
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188198
- Sponsor's protocol ID
- mans lymphoma1
- Status last verified
- Jun 2017
- First submitted
- 20 May 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R in Untreated De Novo Diffuse Large B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT03188198
- Acronym / sponsor ID
- mans lymphoma1
- Conditions
- Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 15 Jun 2017 (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.
This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.
Detailed description
objectives:
- To compare the response rates and toxicity of R-CHOP versus DA-EPOCH-R in untreated CD20+ diffuse large B-cell lymphomas.
- To compare the event-free survival of R-CHOP versus DA-EPOCH-R chemotherapy in untreated CD20+ diffuse large B-cell lymphomas.
- To develop predictors of outcome of R-CHOP and DA-EPOCH-R chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - R-CHOP | Active comparator | Drug: rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastimPatients receive the following treatment:Rituximab 375 mg/m2 IV infusion on Day 1 prior to CHOP chemotherapy.Cyclophosphamide 750 mg/m^2 IV on Day 1.Doxorubicin 50 mg/m^2 IV on Day 1.Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1.Prednisone 40 mg/m^2/day PO on Days 1-5.filgrastim or pegfilgrastim as defined in the protocol Required ancillary medications is administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6. Interventions:-Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: filgrastim-Drug: pegfilgrastim |
| Arm B - DA-EPOCH-R | Experimental | Drug: rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastimPatients receive the following treatment: Cycle 1 Doses:Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy. Doxorubicin 10 mg/m^2/day CIVI on Days 1-4.Etoposide 50 mg/m^2/day CIVI on Days 1-4. Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours). Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions). Prednisone 60 mg/m^2 PO BID on Days 1-5 Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the nadir (nadir usually between Days 10-12) Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6. Interventions: -Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: etoposide-Drug: filgrastim |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease.
- Stage I primary mediastinal (thymic) DLBCL is also eligible. Diagnosis should be based on an adequate tissue sample, including open biopsy or core needle biopsy.
- Needle aspiration for primary diagnosis is unacceptable.
- Diffuse large B-cell lymphoma (includes morphological variants: centroblastic, immunoblastic, T-cell/histiocyte rich, and anaplastic) Mediastinal (thymic) large B-cell lymphoma Intravascular large B-cell lymphoma Patients without adequate frozen material should have a biopsy performed to obtain material.
- 2. Patients may be entered if they have received prior limited field radiation therapy or a short course of glucocorticoids (< 10 days) for an urgent local disease complication at diagnosis (e.g., cord compression, SVC syndrome).
Key exclusion criteria (6 listed)
- 1- Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or low-grade lymphoma in the bone marrow, are not eligible.
- 2- Patients with low international prognostic index are not eligible. 3- Prior cytotoxic chemotherapy or rituximab. Patients who have received chemotherapy for prior malignancies are not eligible.
- 4- Active ischemic heart disease or congestive heart failure. 5- Known lymphomatous involvement of the CNS. A lumbar puncture prior to study is not required in the absence of neurological symptoms.
- 6- Known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible.
- 7- Pregnant and non-nursing. Treatment would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective form of contraception.
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 |
|---|---|---|
| rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastimAlso: rituximab:mabthera, etoposide:vepsid, cyclophosphamide:endoxan, doxorubcin:adriamycin | Drug | Arm A - R-CHOP, Arm B - DA-EPOCH-R |
Primary outcome
Response rate
Time frame: one year post-registration
1 secondary outcome
Event-free survival
Time frame: Up to 3 years post-registration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim in people with Large B Cell Lymphoma, run by Mansoura University 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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Eltantawy, Master (00201091203484, eltantawy.ahmed1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: one year post-registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.