Lymphoma, Large B-Cell, DiffusePhase 1/2R2CHOP-1NCT00901615
Lenalidomide and R-CHOP in B-cell Lymphoma
A Phase 1/2 study testing Lenalidomide and R-CHOP in people with Lymphoma, Large B-Cell, Diffuse and Follicular Lymphoma, run by Lymphoma Study Association at 5 sites in France.
Trial summary
The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Lenalidomide and R-CHOP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesFrance
- Study dates
- 6 Jan 2009to 23 Nov 2015
- Phase
- Phase 1/2
- 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 with one of the following B-cell Lymphoma, CD 20 positive:
- Mantle cell, Marginal zone, follicular
- Histological transformation from low grade to high grade
- Diffuse large B cell
- Aged from 18 to 70 years
- WHO performance status 0, 1 or 2
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- Signed inform consent
- Life expectancy of ≥ 90 days (3 months).
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
- Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
- † A female patient is considered to have childbearing potential unless she meets at least one of the following criteria 1) Age > 50 years and naturally amenorrhoeic for > 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential); or 2) Premature ovarian failure confirmed by a specialist gynaecologist or 3) Previous bilateral salpingo-oophorectomy, or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis.
Who cannot join
- Previous treatment with immunotherapy or chemotherapy except:
- Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion
- Rituximab alone during less than three months, if stopped more than one year before inclusion
- Previous radiotherapy except if localized to one lymph node area
- Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative
- Central nervous system or meningeal involvement
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- Contraindication to any drug contained in the chemotherapy regimen
- HIV disease, active hepatitis B or C
- Any serious active disease or co-morbid medical condition (according to investigator's decision)
- Any of the following laboratory abnormalities :
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L).
- Platelet count < 100,000/mm3 (100 x 109/L).
- Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia.
- Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min
- Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide.
- Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- Subjects with ≥ Grade 2 neuropathy.
- Prior use of lenalidomide.
- Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Dijon
Dijon, 21034
CHRU Lille
Lille, 59037
CHU Lyon Sud
Pierre-Bénite, 69310
Centre Henri Becquerel
Rouen, 76038
CHU Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Phase IB Study of Escalating Doses of REVLIMID in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma
The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).
Read the detailed description
The study is a dose escalation study of lenalidomide (Revlimid) administered orally during 14 days in combination with fixed doses of rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks (R-CHOP 21) in patients with B-cell lymphoma.
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
- Being tested
- Lenalidomide and R-CHOP
- Keywords
- lymphoma, lenalidomide, gela
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide and R-CHOPDrug
Also called REVLIMID
Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide and R-CHOP | Experimental | Escalating Lenalidomide dose from 2.5 to 25 mg Lenalidomide and R-CHOP Receives: Drug: Lenalidomide and R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicities
Measured: 42 days
Secondary outcomes (5)
Complete response rate and Overall response rate at the end of treatment
Measured: 3 months after the end of treatment
Complete and Overall response rates after induction
Measured: at the end of third cycle of treatment (between Day 56 and Day 63)
Progression-Free Survival and Overall survival
Measured: 7 years
Duration of response
Measured: 7 years
Collection of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study start6 Jan 2009
- Primary completion19 Nov 2010
- Study completion23 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lymphoma Study Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé TILLY, Prof, Principal investigator, Lymphoma Study Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901615
- Sponsor's protocol ID
- R2CHOP-1
- Acronym
- R2CHOP-1
- Status last verified
- Aug 2018
- First submitted
- 13 May 2009
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Study of Escalating Doses of REVLIMID in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00901615
- Acronym / sponsor ID
- R2CHOP-1 / R2CHOP-1
- Conditions
- Lymphoma, Large B-Cell, Diffuse, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
- Keywords
- lymphoma, lenalidomide, gela
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Lymphoma Study AssociationUniversity, hospital or other
- Study start
- 6 Jan 2009 (actual)
- Primary completion
- 19 Nov 2010 (actual)
- Study completion
- 23 Nov 2015 (actual)
- First posted
- 14 May 2009 (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 the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).
Detailed description
The study is a dose escalation study of lenalidomide (Revlimid) administered orally during 14 days in combination with fixed doses of rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks (R-CHOP 21) in patients with B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide and R-CHOP | Experimental | Drug: Lenalidomide and R-CHOPEscalating Lenalidomide dose from 2.5 to 25 mg Lenalidomide and R-CHOP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with one of the following B-cell Lymphoma, CD 20 positive:
- Aged from 18 to 70 years
- WHO performance status 0, 1 or 2
- Signed inform consent
- Life expectancy of ≥ 90 days (3 months).
Key exclusion criteria (23 listed)
- Previous treatment with immunotherapy or chemotherapy except:
- Previous radiotherapy except if localized to one lymph node area
- Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative
- Central nervous system or meningeal involvement
- Contraindication to any drug contained in the chemotherapy regimen
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 |
|---|---|---|
| Lenalidomide and R-CHOPAlso: REVLIMIDLenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21. | Drug | Lenalidomide and R-CHOP |
Primary outcome
Incidence of Dose Limiting Toxicities
Time frame: 42 days
5 secondary outcomes
Complete response rate and Overall response rate at the end of treatment
Time frame: 3 months after the end of treatment
Complete and Overall response rates after induction
Time frame: at the end of third cycle of treatment (between Day 56 and Day 63)
Progression-Free Survival and Overall survival
Time frame: 7 years
Duration of response
Time frame: 7 years
Collection of adverse events
Time frame: 6 months
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 23 Aug 2018.
- GELALink provided by the sponsor.
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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.
Hervé TILLY, Prof principal investigator
Lymphoma Study Association
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide and R-CHOP in people with Lymphoma, Large B-Cell, Diffuse and Follicular Lymphoma, run by Lymphoma Study Association at 5 sites in France.
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 11 inclusion and 23 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Dose Limiting Toxicities (time frame: 42 days). 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 23 Aug 2018.