Non-Hodgkin LymphomaNCT00429065
Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.
An observational study of Non-Hodgkin Lymphoma, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Rituximab
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2007to Jan 2007
- Phase
- Observational
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Large B cell Non-Hodgkin Lymphoma CD20+
- BCL-6 negative
- Age < 61 years old
- ECOG 2 or less
- IPI low, low intermediate
- Stage II, III or IV
- Signed Informed Consent
Who cannot join
- Stage I
- Previous treatment
- Lymphomatous central nervous system involvement
- Heart disease
- Kidney failure (serum creatinine > 2 mg/dl)
- HIV +
- Viral Hepatitis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerologia
Mexico City, D.F., 14080
About this study
Official title: Selection of Young Patients (< 61 Years), With Good Prognosis Diffuse Large B Cell Lymphoma, According to the Immunophenotype (BCL-6 Negative) to be Treated With Chemoimmunotherapy, With R-CHOP. A Pilot Study.
The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.
Read the detailed description
Treatment with rituximab and chemotherapy (R-CHOP)is the accepted treatment for young patients with diffuse large B cell Non-Hodgkin's Lymphoma. However not every patient benefits with this expensive therapy. Recent data suggest that patients with BCL-6 negative lymphoma are more sensitive to Rituximab therapy. It is also known that patients with high-intermediate and high IPI risk does not benefit form standard three weekly CHOP chemotherapy.
In this study we intend to define a subgroup of patients in whom this therapy will be of maximum benefit.
We will prospectively treat a group of patients with the following characteristics:
< 60 years old low and low intermediate IPI risk BCL-6 negative B-cell NHL Treatment regimen: R-CHOP (standard dosis) for 8 cycles
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Rituximab
- Keywords
- Non-Hodgkin lymphoma, rituximab, immunotherapy
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2007
- Study completionJan 2007
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 Non-Hodgkin 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Investigators
- Pedro Sobrevilla-Calvo, MD, Principal investigator, Instituto Nacional de Cancerologia MexicoSilvia Rivas-Vera, MD, Principal investigator, Instituto Nacional de Cancerologia Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429065
- Sponsor's protocol ID
- Hemato INCAN 01/2007
- Status last verified
- Jan 2007
- First submitted
- 30 Jan 2007
- Last updated
- 31 Jan 2007
- Results posted
- No
Publications
Winter JN, Weller EA, Horning SJ, Krajewska M, Variakojis D, Habermann TM, Fisher RI, Kurtin PJ, Macon WR, Chhanabhai M, Felgar RE, Hsi ED, Medeiros LJ, Weick JK, Reed JC, Gascoyne RD. Prognostic significance of Bcl-6 protein expression in DLBCL treated with CHOP or R-CHOP: a prospective correlative study. Blood. 2006 Jun 1;107(11):4207-13. doi: 10.1182/blood-2005-10-4222. Epub 2006 Jan 31.
PubMed 16449523Lossos IS, Jones CD, Warnke R, Natkunam Y, Kaizer H, Zehnder JL, Tibshirani R, Levy R. Expression of a single gene, BCL-6, strongly predicts survival in patients with diffuse large B-cell lymphoma. Blood. 2001 Aug 15;98(4):945-51. doi: 10.1182/blood.v98.4.945.
PubMed 11493437Lossos IS, Czerwinski DK, Alizadeh AA, Wechser MA, Tibshirani R, Botstein D, Levy R. Prediction of survival in diffuse large-B-cell lymphoma based on the expression of six genes. N Engl J Med. 2004 Apr 29;350(18):1828-37. doi: 10.1056/NEJMoa032520.
PubMed 15115829
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Young Patients (< 61 Years), With Good Prognosis Diffuse Large B Cell Lymphoma, According to the Immunophenotype (BCL-6 Negative) to be Treated With Chemoimmunotherapy, With R-CHOP. A Pilot Study.
- ClinicalTrials.gov ID
- NCT00429065
- Acronym / sponsor ID
- Hemato INCAN 01/2007
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Non-Hodgkin lymphoma, rituximab, immunotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jan 2007
- First posted
- 31 Jan 2007 (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 purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.
Detailed description
Treatment with rituximab and chemotherapy (R-CHOP)is the accepted treatment for young patients with diffuse large B cell Non-Hodgkin's Lymphoma. However not every patient benefits with this expensive therapy. Recent data suggest that patients with BCL-6 negative lymphoma are more sensitive to Rituximab therapy. It is also known that patients with high-intermediate and high IPI risk does not benefit form standard three weekly CHOP chemotherapy.
In this study we intend to define a subgroup of patients in whom this therapy will be of maximum benefit.
We will prospectively treat a group of patients with the following characteristics:
< 60 years old low and low intermediate IPI risk BCL-6 negative B-cell NHL Treatment regimen: R-CHOP (standard dosis) for 8 cycles
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Diagnosis of Large B cell Non-Hodgkin Lymphoma CD20+
- BCL-6 negative
- Age < 61 years old
- ECOG 2 or less
- IPI low, low intermediate
Key exclusion criteria (8 listed)
- Stage I
- Previous treatment
- Lymphomatous central nervous system involvement
- Heart disease
- Kidney failure (serum creatinine > 2 mg/dl)
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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2007.
- Background: PubMed 16449523Winter JN, Weller EA, Horning SJ, Krajewska M, Variakojis D, Habermann TM, Fisher RI, Kurtin PJ, Macon WR, Chhanabhai M, Felgar RE, Hsi ED, Medeiros LJ, Weick JK, Reed JC, Gascoyne RD. Prognostic significance of Bcl-6 protein expression in DLBCL treated with CHOP or R-CHOP: a prospective correlative study. Blood. 2006 Jun 1;107(11):4207-13. doi: 10.1182/blood-2005-10-4222. Epub 2006 Jan 31.
- Background: PubMed 11493437Lossos IS, Jones CD, Warnke R, Natkunam Y, Kaizer H, Zehnder JL, Tibshirani R, Levy R. Expression of a single gene, BCL-6, strongly predicts survival in patients with diffuse large B-cell lymphoma. Blood. 2001 Aug 15;98(4):945-51. doi: 10.1182/blood.v98.4.945.
- Background: PubMed 15115829Lossos IS, Czerwinski DK, Alizadeh AA, Wechser MA, Tibshirani R, Botstein D, Levy R. Prediction of survival in diffuse large-B-cell lymphoma based on the expression of six genes. N Engl J Med. 2004 Apr 29;350(18):1828-37. doi: 10.1056/NEJMoa032520.
Related trials for Non-Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
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.
Pedro Sobrevilla-Calvo, MD principal investigator
Instituto Nacional de Cancerologia Mexico
Silvia Rivas-Vera, MD principal investigator
Instituto Nacional de Cancerologia Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
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 7 inclusion and 8 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 31 Jan 2007. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Rivas-Vera, MD (56 28 04 46, srivasv02@yahoo.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00429065, 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 31 Jan 2007.