Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT01066429
DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma
A Phase 2 study testing Dexamethasone and dose-dense immunochemoterapy in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Hospital Universitario Principe de Asturias at 1 site in Spain.
Trial summary
Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as R-CHOP14. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- Dexamethasone and dose-dense immunochemoterapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Dec 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing the Informed Consent.
- Histology: diffuse large B-cell lymphoma de novo (primary mediastinal B-cell lymphomas will be included provided that they have a mass greater than 7 cm in larger diameter) and follicular NHL grade 3b.
- aaIPI: 2-3.
- Age: Between 18 and 70 years.
- General Condition (ECOG/WHO): Proper organic function, defined by: FEVI ≥ 40%, serum creatinine < 150 µmol/L, serum bilirubin < 30 µmol/L, control of other medical conditions such as: infection, leukocytes ≥ 3.5 x 109/l and platelets ≥ 100 x 109/l (except if they are caused by lymphomatous infiltration of bone marrow or of the spleen).
Who cannot join
- HIV-positive.
- Pregnancy or breastfeeding.
- Serious disease compromising the performance of the therapeutic regimen.
- Recent history of another malignant disease (except skin cancer different from melanoma or carcinoma in-situ of the cervix), prior radiotherapy or chemotherapy, history of indolent lymphoma.
- CNS infiltration at diagnosis.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Principe de Asturias University Hospital
Alcalá de Henares, Madrid, 28805
Julio Garcia-Suarez, MD, PhD, 34-91-8878100 ext. 2099, jgarciasu.hupa@salud.madrid.org
About this study
Official title: Treatment With Infusional Dose-adjusted Etoposide/Vincristine/Doxorubicin/Bolus Cyclophosphamide/Dexamethasone and Rituximab (DA-EDOCH14-R) in Patients With Poor-prognosis Diffuse Large B-cell Lymphoma
Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007, 136:276). Despite this improvement in outcome, the search for new treatment strategies should continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone (based upon data which demonstrated that the former was associated with enhanced Central Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would be feasible and might improve the outcome in this group of patients.
Read the detailed description
Medication, Dose and Method for Administration:
- Rituximab: 375 mg/m2, endovenous, according to the protocol of the service, day 1 (except in the first cycle, in which it will be on day 5).
- Etoposide: 50 mg/m2/day, in continuous 24-hour infusion, days 1 to 4.
- Adriamycin: 10 mg/m2/day, in continuous 24-hour infusion of, days 1 to 4.
- Vincristine: 0.4 mg/m2/day, in continuous 24-hour infusion, days 1 to 4
- Dexamethasone: 40 mg, endovenous, days 1 to 5. Followed by prednisone 30 mg (day +6), 20 mg (day +7), and 10 mg (day +8).
- Cyclophosphamide: 750 mg/m2, endovenous, in 30 minutes, day 5, after ending the continuous infusion of adriamycin, etoposide and vincristine.
- MESNA (If the dose of Cyclophosphamide is > 1 g/m2
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Being tested
- Dexamethasone and dose-dense immunochemoterapy
- Keywords
- poor-prognosis diffuse large B-cell lymphoma, dose-adjusted, R-EDOCH-14, rituximab, age-adjusted IPI, toxicity
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone and dose-dense immunochemoterapyDrug
Also called Dose-dense therapy, Rituximab, dexamethasone
Administration every 14 days of the EDOCH-R scheme.
| Study group | Role | What they receive |
|---|---|---|
| Poor prognosis DLBCL | No intervention | Newly diagnosed patients with DLBCL and an age-adjusted IPI 2-3 Receives: Drug: Dexamethasone and dose-dense immunochemoterapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of the EDOCH14-R scheme at an adjusted dose
Measured: Between December 2009 and January 2012
Secondary outcomes (1)
hematological and extra-hematological toxicity of the EDOCH14-R scheme
Measured: Between december 2009 and January 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B-Cell Lymphoma (DLBCL)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Principe de Asturias
- Sponsor type
- University, hospital or other
- Investigators
- Julio Garcia-Suarez, MD, PhD, Principal investigator, Service of Hematology, Principe de Asturias University Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066429
- Sponsor's protocol ID
- DA-EDOCH14-R/07
- Status last verified
- Dec 2009
- First submitted
- 8 Feb 2010
- Last updated
- 12 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia-Suarez J, Flores E, Callejas M, Arribas I, Gil-Fernandez JJ, Olmedilla G, Curto N, Guillen H, Casco CR, Martin Y, Burgaleta C. Two-weekly dose-adjusted (DA)-EPOCH-like chemotherapy with high-dose dexamethasone plus rituximab (DA-EDOCH14-R) in poor-prognostic untreated diffuse large B-cell lymphoma. Br J Haematol. 2013 Feb;160(4):510-4. doi: 10.1111/bjh.12144. Epub 2012 Dec 11.
PubMed 23228045
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Infusional Dose-adjusted Etoposide/Vincristine/Doxorubicin/Bolus Cyclophosphamide/Dexamethasone and Rituximab (DA-EDOCH14-R) in Patients With Poor-prognosis Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01066429
- Acronym / sponsor ID
- DA-EDOCH14-R/07
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Keywords
- poor-prognosis diffuse large B-cell lymphoma, dose-adjusted, R-EDOCH-14, rituximab, age-adjusted IPI, toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Universitario Principe de AsturiasUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Feb 2010 (estimated)
- 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.
Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007, 136:276). Despite this improvement in outcome, the search for new treatment strategies should continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone (based upon data which demonstrated that the former was associated with enhanced Central Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would be feasible and might improve the outcome in this group of patients.
Detailed description
Medication, Dose and Method for Administration:
- Rituximab: 375 mg/m2, endovenous, according to the protocol of the service, day 1 (except in the first cycle, in which it will be on day 5).
- Etoposide: 50 mg/m2/day, in continuous 24-hour infusion, days 1 to 4.
- Adriamycin: 10 mg/m2/day, in continuous 24-hour infusion of, days 1 to 4.
- Vincristine: 0.4 mg/m2/day, in continuous 24-hour infusion, days 1 to 4
- Dexamethasone: 40 mg, endovenous, days 1 to 5. Followed by prednisone 30 mg (day +6), 20 mg (day +7), and 10 mg (day +8).
- Cyclophosphamide: 750 mg/m2, endovenous, in 30 minutes, day 5, after ending the continuous infusion of adriamycin, etoposide and vincristine.
- MESNA (If the dose of Cyclophosphamide is > 1 g/m2
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poor prognosis DLBCL | No intervention | Drug: Dexamethasone and dose-dense immunochemoterapyNewly diagnosed patients with DLBCL and an age-adjusted IPI 2-3 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signing the Informed Consent.
- Histology: diffuse large B-cell lymphoma de novo (primary mediastinal B-cell lymphomas will be included provided that they have a mass greater than 7 cm in larger diameter) and follicular NHL grade 3b.
- aaIPI: 2-3.
- Age: Between 18 and 70 years.
- General Condition (ECOG/WHO): Proper organic function, defined by: FEVI ≥ 40%, serum creatinine < 150 µmol/L, serum bilirubin < 30 µmol/L, control of other medical conditions such as: infection, leukocytes ≥ 3.5 x 109/l and platelets ≥ 100 x 109/l (except if they are caused by lymphomatous infiltration of bone marrow or of the spleen).
Key exclusion criteria (5 listed)
- HIV-positive.
- Pregnancy or breastfeeding.
- Serious disease compromising the performance of the therapeutic regimen.
- Recent history of another malignant disease (except skin cancer different from melanoma or carcinoma in-situ of the cervix), prior radiotherapy or chemotherapy, history of indolent lymphoma.
- CNS infiltration at diagnosis.
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 |
|---|---|---|
| Dexamethasone and dose-dense immunochemoterapyAlso: Dose-dense therapy, Rituximab, dexamethasoneAdministration every 14 days of the EDOCH-R scheme. | Drug | Poor prognosis DLBCL |
Primary outcome
efficacy of the EDOCH14-R scheme at an adjusted dose
Time frame: Between December 2009 and January 2012
1 secondary outcome
hematological and extra-hematological toxicity of the EDOCH14-R scheme
Time frame: Between december 2009 and January 2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2010.
- Derived from this study: PubMed 23228045Garcia-Suarez J, Flores E, Callejas M, Arribas I, Gil-Fernandez JJ, Olmedilla G, Curto N, Guillen H, Casco CR, Martin Y, Burgaleta C. Two-weekly dose-adjusted (DA)-EPOCH-like chemotherapy with high-dose dexamethasone plus rituximab (DA-EDOCH14-R) in poor-prognostic untreated diffuse large B-cell lymphoma. Br J Haematol. 2013 Feb;160(4):510-4. doi: 10.1111/bjh.12144. Epub 2012 Dec 11.
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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.
Julio Garcia-Suarez, MD, PhD principal investigator
Service of Hematology, Principe de Asturias University Hospital,
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 Dexamethasone and dose-dense immunochemoterapy in people with Diffuse Large B-Cell Lymphoma (DLBCL), run by Hospital Universitario Principe de Asturias at 1 site in Spain.
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 5 inclusion and 5 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 12 Feb 2010. 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 Spain. 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 Julio Garcia-Suarez, MD, PhD (34-91-8878100 ext. 2099, jgarciasu.hupa@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of the EDOCH14-R scheme at an adjusted dose (time frame: Between December 2009 and January 2012). 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 NCT01066429, which also lists 1 linked publication.
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 12 Feb 2010.