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Diffuse, Large B-Cell, LymphomaPhase 2NCT01848132

Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.

A Phase 2 study testing Bortezomib, Rituximab and Cyclophosphamide in people with Diffuse, Large B-Cell, Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 21 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of the patients will fail first line chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diffuse, Large B-Cell, Lymphoma
What is being tested?
Bortezomib, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
21 sitesSpain
Study dates
3 Oct 2013to Aug 2018
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

  • Patients diagnosed with primary diffuse DLBCL who have never received treatment for this condition.
  • Age between 18 and 70 years.
  • Age-adjusted IPI (aIPI) higher than 1, or equal 1 with high levels of beta-2-microglobulin (above UNL)
  • Cluster of Differentiation 20 (CD20) positive b lymphocytes.
  • Eastern Cooperative Oncology Group (ECOG) 0-3.
  • More than 12 weeks of life expectancy.
  • Signed Informed Consent.
  • Nor pregnant women nor breast-feeding women without heterosexual activity during the entire study. Women with heterosexual activity only if they are willing to use two methods of contraceptive. The two contraceptive methods can be, two barrier method or a barrier method combinated with an hormonal contraceptive method to prevent pregnancy, used during the entire study and until 3 months after the study completion.

Who cannot join

  • Pregnant women or in breast-feeding period, or adults in childbearing period not using an effective contraception method.
  • Patients with Central Nervous System (CNS) lymphoma.
  • Severely impaired renal function (creatinine> 2.5 UNL) or hepatic function impairment (bilirubin or Alanine Amino Transaminase (ALT) / Aspartate Aminotransferase (AST) > 3 UNL), unless it is suspected to be due to the disease.
  • Human immunodeficiency virus (HIV) positive patients
  • Patient previously treated for the DLBCL
  • Positive determination of chronic hepatitis B (defined as positive serology for HBsAg). It will be allowed to enroll patients with hidden or previous hepatitis B (defined as positive antibodies against the core of the hepatitis B virus [HBcAb] and HBsAg negative) if undetectable Hepatitis B Virus (HBV) DNA.
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  • Positive results for hepatitis C (antibody serology for hepatitis C virus ((HCV)). Patients with HCV positive may only participate if the Polymerase Chain Reaction (PCR) result is negative for HCV RNA.
  • History of cardiovascular disease with ventricular ejection fraction < 50%.
  • Patients with severe psychiatric conditions that may interfere with their ability to understand the study (including alcoholism or drug addiction).
  • Patients with known hypersensitivity to murine proteins or any other components of the study drugs.
  • Transformed follicular lymphoma.
  • History of other neoplastic malignancy with < 5 year of complete response (except for Squamous Cell Carcinoma of the Skin or cervical Carcinoma in situ).
  • Presence of uncontrolled conditions: cardiac, respiratory, neurologic, metabolic etc., not related to lymphoma.
  • Uncontrolled hypertension (diastolic blood pressure over 110 mmHg).

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Spain21 sites

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Institut Català d'Oncologia, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital de Jerez

    Jerez de la Frontera, Cádiz, 11407

  • Institut Català d'Oncologia, Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Centro Integral Oncológico Clara Campal

    Madrid, 28050

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital Son Llàtzer

    Palma, Balearic Islands, 07198

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Doctor Peset

    Valencia, 46017

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36036

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

Other trials in Spain

About this study

Official title: Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.

Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of the patients will fail first line chemotherapy. The International Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to identify patients with different outcome.

There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The survival of these patients remains poor, with EFS around 40%.

Read more

The combination of RCHOP with new drugs is an attractive approach to treat these patients.

The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2 years, with a diagnosis of DLBCL with an aIPI > 1 or an aIPI =1 with increased levels of beta-2-microglobulin (above the Upper Limits of Normal.)

Read the detailed description

Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of the patients will fail first line chemotherapy. The International Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to identify patients with different outcome.

CHOP chemotherapy administered every 21 days has been for years the standard therapy for advanced DLBCL achieving a long term overall survival (OS) of about 40%. Many studies show that the addition of the monoclonal antibody Rituximab improves the patients survival achieving higher rates of event-free survival in elderly patients with both,favourable and unfavourable IPI score. R-CHOP also improved survival in young patients with favourable IPI score.

There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The survival of these patients remains poor, with EFS around 40%.

The combination of RCHOP with new drugs is an attractive approach to treat these patients.

The investigators propose a phase II randomized clinical trial for young patients with unfavourable IPI score DLBCL using 6 cycles of the combination of subcutaneous Bortezomib with R-CAP (RCHOP without vincristine, to avoid neuropathy) comparing with the standard immunochemotherapy regimen R- CHOP every 21 days.

The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2 years, with a diagnosis of DLBCL with aIPI > 1 or aIPI =1 with increased levels of beta-2-microglobulin (above the Upper Limits of Normal).

Keywords
Lymphoma, Large B-Cell
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Also called Velcade

    Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15.

  • RituximabDrug

    Rituximab: intravenous, 375 mg/m2, day 1

  • CyclophosphamideDrug

    Cyclophosphamide: intravenous, 750 mg/m2, day 1

  • DoxorubicinDrug

    Also called Adriamycin

    Adriamycin:intravenous, 50 mg/m2, day 1

  • PrednisoneDrug

    Prednisone: oral, 100 mg, days 1-5

  • VincristineDrug

    Vincristine: intravenous, 1,4 mg/m2, day 1

Study groups in NCT01848132
Study groupRoleWhat they receive
R-CHOPActive comparator6 cycles every 21 days. * Rituximab: intravenous, 375 mg/m2, day 1 * Cyclophosphamide: intravenous, 750 mg/m2, day 1 * Doxorubicin: intravenous, 50 mg/m2, day 1 * Vincristine: intravenous, 1,4 mg/m2, day 1 * Prednisone: oral, 100 mg, days 1-5
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Vincristine
B-R-CAPExperimental6 cycles every 21 days * Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15 * Rituximab: intravenous, 375 mg/m2, day 1 * Cyclophosphamide: intravenous, 750 mg/m2, day 1 * Doxorubicin: intravenous, 50 mg/m2, day 1 * Prednisone: oral, 100 mg, days 1-5
Receives: Drug: Bortezomib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with Event-Free Survival at 2 years.

    To evaluate the proportion of patients with event-free survival at 2 years in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL).

    UNL= Upper Normal Limit.

    Measured: During treatment period, there will be assessments every 2 cycles. After end of treatment every 3 month the first year, every 6 months the second year and annually from 3rd to 5th year

Secondary outcomes (6)

  1. Event-Free survival at 2 years in the different subtypes of DLBCL

    Event-free survival at 2 years in the different subtypes of DLBCL subgroups: Germinal center B-cell-like (GCB)/non-GCB.

    Measured: Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year

  2. Overall survival at 2 years

    Overall survival at 2 years in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL)

    Measured: Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year.

  3. Overall response rate and complete remissions

    Overall response rate and complete remissions in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL).

    Measured: Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year.

  4. Toxicity according to the CTC criteria

    Toxicity according to the Common Toxicity Criteria (CTC) (version 3.0) of the National Cancer Institute (NCI).

    Measured: Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year.

  5. To evaluate the predictive value for EFS of interim PET/CT evaluation

    To evaluate the predictive value for EFS of interim PET/CT evaluation after 2 and 4 cycles of chemotherapy.

    The PET Network group of Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (GELTAMO), will conduct this blind central review in real-time (qualitative and quantitative, prospective central review of the PET scans performed)

    Measured: Before treatment, after second cycle, after fourth cycle and after treatment completion.

  6. To identify clinical and biological prognostic factors for response and survival.

    To identify clinical and biological prognostic factors for response and survival.

    Measured: Once the treatment is started, there will be weekly safety visits, a visit before each treatment cycle, a visit at day 60 after the sixth cycle and then follow-up visits every three months the first 2 years and every 6 months until the 5th year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2013 (estimated)
  2. Study start3 Oct 2013
  3. Primary completionJan 2018
  4. Study completionAug 2018

Resources

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
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01848132
Sponsor's protocol ID
BRCAP-GELTAMO12
Other IDs
2012-005138-12
Status last verified
Sep 2018
First submitted
3 May 2013
Last updated
19 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib, Rituximab and Cyclophosphamide in people with Diffuse, Large B-Cell, Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 21 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 8 inclusion and 14 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

Proportion of patients with Event-Free Survival at 2 years. (time frame: During treatment period, there will be assessments every 2 cycles. After end of treatment every 3 month the first year, every 6 months the second year and annually from 3rd to 5th year). 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 NCT01848132.

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 19 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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