Diffuse Large B-cell LymphomaPhase 2R-MEGACHOPNCT01361191
Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
A Phase 2 study testing R-MEGACHOP in people with Diffuse Large B-cell Lymphoma and Follicular Grade 3B Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites in Spain.
Trial summary
The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma, Follicular Grade 3B Lymphoma
- What is being tested?
- R-MEGACHOP
- Type of treatment
- Injection or infusion
- How many people
- 71 participants
- Where
- 19 sitesSpain
- Study dates
- Jun 2007to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- follicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, histologically confirmed with CD20+
- aged between 18 and 65 years. Patients aged from 65 to 70 years can be included according to the investigator's criteria regarding the patients' global health status and the absence of excluding comorbidity.
- IPI adjusted to the age over 1 or a-IPI and beta2-microglobulin equal or higher than 3 mg/dl 3. Punctuation in the ECOG grade from 0 to 4
- Life expectancy over 12 weeks
- Written informed consent form 6. New diagnosed patient without any previous treatment
Who cannot join
- Existence of severe cardiac, pulmonary, neurologic, psychiatric and metabolic diseases not caused by the lymphoma.
- uncontrolled high blood pressure (diastolic pressure in rest > 115 mmHg)
- Altered hepatic function (bilirubin or AST/ALT superior or equal at 2 times the superior limit of normality) or renal (creatinine equal or superior at 1.5 times the superior limit of normality) not caused by the lymphoma.
- other malignant neoplasias along the past 5 years, except skin tumors, excluded melanoma or carcinoma in situ of cervix
- patients positive for HIV
- patients with transformed follicular lymphoma
Show all 9Show fewer
- pregnant women or in nursing; women of childbearing age who do not use an adequate contraceptive method before being included in the study
- ventricular ejection fraction inferior to 50%
- patients with severe psychiatric diseases which can interfere with their ability for understanding the study (including alcoholism or drug addiction)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Spain19 sites
Complejo Hospitalario de Jaén
Jaén, Jaén, 23006
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407
ICO- Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario La Princesa
Madrid, Madrid, 28006
Hospital Universitario Gregorio Marañon
Madrid, Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Univ. Morales Meseguer
Murcia, Murcia, 30008
Hospital Univ. Son Dureta
Palma de Mallorca, Mallorca, 07014
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, 07198
Clínica Universitaria de Navarra
Pamplona, Pamplona, 31008
Hospital Universitario de Salamanca
Salamanca, Salamanca, 37007
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Clínico Univ. de Santiago
Santiago de Compostela, Galicia, 15706
Hospital General de Segovia
Segovia, Segovia, 40002
Hospital Universitario Río Hortega
Valladolid, Valladolid, 47010
Hospital Universitario Virgen de la Concha
Zamora, Zamora, 49022
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
Official title: Early Treatment Stratification Based on PET Scan Response to R-MEGACHOP Followed by R-MEGACHOP or R-IFE Plus Peripheral Autologous Stem Cell Transplant (PBSCT) in Patients With Poor Prognosis DLBCL
The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP without transplant.
Read the detailed description
In addition to the above:
- To evaluate the overall survival after three years.
- To determine the rate of global responses and complete remissions, uncertain and partial.
- To determine the duration of the complete response after the treatment termination.
- To carry out an exploratory follow up of the event free survival and the overall survival at 5 years.
- To evaluate the treatment toxicity according CTC criteria (version 3.0) of the National Cancer Institute (NCI).
- To asses the role of PET in the disease stage and response evaluation compared to CAT.
- To identify the predictable response factors after 6 cycles of treatment with R-MegaCHOP administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH in patients with DLBCL of severe prognosis.
- To evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment and/or R-IFE in reference with delays with the cycles administration and reductions of the chemotherapy dose (planned dose administrated in the planned term).
- Being tested
- R-MEGACHOP
- Keywords
- DLBCL, PET, IPI, R-MegaCHOP, Autologous stem cell transplantation
- 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.
R-MEGACHOPDrug
- If PET + after third cycle: 2 cycles of R-IFE followed by PBSCT
- If PET - after third cycle: 3 additional cycles of R-MegaCHOP - R-MegaCHOP: cycles every 21 days RITUXIMAB Dosage: 375mg/m2, IV, day 1 CICLOPHOSPHAMIDE Dosage: 1500 mg/m2, IV, day 1 DOXORUBICIN Dosage: 65 mg/m2, IV, day 1 VINCRISTIN: Dosage 1.4 mg/m2 (max. 2.0 mg/m2, IV, day 1 PREDNISONE Dosage: 60 mg/m2, IV, day 1-5
R-IFE: 2 cycles every 21 days:
IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3.
ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3).
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival at 3y in pat with DLBCL with a-IPI>1 or a-IPI=1 and ß2 µglobulin>=3mg/dl in pat PET+ after 3cycles of R-MegaCHOP and early rescue with R-IFE+TAPH or in pat PET- after 3cycles R-MegaCHOP followed by 3cycles of R-MegaCHOP without TAPH
Measured: 5 years follow-up
Secondary outcomes (1)
To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.
Measured: 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJun 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Fuster, MD, Principal investigator, Son Dureta HospitalCarlos Grande, MD, Principal investigator, 12 Octubre HospitalJosé Luís Bello, MD, Principal investigator, Santiago HospitalMaria José Ramirez, MD, Principal investigator, Jerez HospitalCarlos Panizo, MD, Principal investigator, Navarra ClinicElena Pérez, MD, Principal investigator, Morales i Meseguer HospitalJorge Gayoso, MD, Principal investigator, Gregorio Marañon HospitalReyes Arranz, MD, Principal investigator, Princesa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361191
- Sponsor's protocol ID
- GEL/TAMO-2006
- Other IDs
- EudraCT number 2006-005254-68
- Acronym
- R-MEGACHOP
- Status last verified
- Oct 2013
- First submitted
- 14 Apr 2008
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment Stratification Based on PET Scan Response to R-MEGACHOP Followed by R-MEGACHOP or R-IFE Plus Peripheral Autologous Stem Cell Transplant (PBSCT) in Patients With Poor Prognosis DLBCL
- ClinicalTrials.gov ID
- NCT01361191
- Acronym / sponsor ID
- R-MEGACHOP / GEL/TAMO-2006
- Keywords
- DLBCL, PET, IPI, R-MegaCHOP, Autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 May 2011 (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.
The aim of the study is to evaluate the event free survival at three years in patients with diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP without transplant.
Detailed description
In addition to the above:
- To evaluate the overall survival after three years.
- To determine the rate of global responses and complete remissions, uncertain and partial.
- To determine the duration of the complete response after the treatment termination.
- To carry out an exploratory follow up of the event free survival and the overall survival at 5 years.
- To evaluate the treatment toxicity according CTC criteria (version 3.0) of the National Cancer Institute (NCI).
- To asses the role of PET in the disease stage and response evaluation compared to CAT.
- To identify the predictable response factors after 6 cycles of treatment with R-MegaCHOP administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH in patients with DLBCL of severe prognosis.
- To evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment and/or R-IFE in reference with delays with the cycles administration and reductions of the chemotherapy dose (planned dose administrated in the planned term).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- follicular lymphoma grade III diagnosed patients, diffuse large B-cell lymphoma, histologically confirmed with CD20+
- aged between 18 and 65 years. Patients aged from 65 to 70 years can be included according to the investigator's criteria regarding the patients' global health status and the absence of excluding comorbidity.
- IPI adjusted to the age over 1 or a-IPI and beta2-microglobulin equal or higher than 3 mg/dl 3. Punctuation in the ECOG grade from 0 to 4
- Life expectancy over 12 weeks
- Written informed consent form 6. New diagnosed patient without any previous treatment
Key exclusion criteria (9 listed)
- Existence of severe cardiac, pulmonary, neurologic, psychiatric and metabolic diseases not caused by the lymphoma.
- uncontrolled high blood pressure (diastolic pressure in rest > 115 mmHg)
- Altered hepatic function (bilirubin or AST/ALT superior or equal at 2 times the superior limit of normality) or renal (creatinine equal or superior at 1.5 times the superior limit of normality) not caused by the lymphoma.
- other malignant neoplasias along the past 5 years, except skin tumors, excluded melanoma or carcinoma in situ of cervix
- patients positive for HIV
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 |
|---|---|---|
| R-MEGACHOP* If PET + after third cycle: 2 cycles of R-IFE followed by PBSCT * If PET - after third cycle: 3 additional cycles of R-MegaCHOP - R-MegaCHOP: cycles every 21 days RITUXIMAB Dosage: 375mg/m2, IV, day 1 CICLOPHOSPHAMIDE Dosage: 1500 mg/m2, IV, day 1 DOXORUBICIN Dosage: 65 mg/m2, IV, day 1 VINCRISTIN: Dosage 1.4 mg/m2 (max. 2.0 mg/m2, IV, day 1 PREDNISONE Dosage: 60 mg/m2, IV, day 1-5 R-IFE: 2 cycles every 21 days: IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3. ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3). | Drug | – |
Primary outcome
Event free survival at 3y in pat with DLBCL with a-IPI>1 or a-IPI=1 and ß2 µglobulin>=3mg/dl in pat PET+ after 3cycles of R-MegaCHOP and early rescue with R-IFE+TAPH or in pat PET- after 3cycles R-MegaCHOP followed by 3cycles of R-MegaCHOP without TAPH
Time frame: 5 years follow-up
1 secondary outcome
To evaluate the overall survival after three years. Further secondary outcomes as described in study summary.
Time frame: 5 years follow-up
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 30 Oct 2013.
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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.
José Fuster, MD principal investigator
Son Dureta Hospital
Carlos Grande, MD principal investigator
12 Octubre Hospital
José Luís Bello, MD principal investigator
Santiago Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R-MEGACHOP in people with Diffuse Large B-cell Lymphoma and Follicular Grade 3B Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 19 sites 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 9 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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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?
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?
Event free survival at 3y in pat with DLBCL with a-IPI>1 or a-IPI=1 and ß2 µglobulin>=3mg/dl in pat PET+ after 3cycles of R-MegaCHOP and early rescue with R-IFE+TAPH or in pat PET- after 3cycles R-MegaCHOP followed by 3cycles of R-MegaCHOP without TAPH (time frame: 5 years follow-up). 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 30 Oct 2013; AzTrials last refreshed its copy on 6 Nov 2026.