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Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line


Phase 3
60 Years
80 Years
Open (Enrolling)
Both
Lymphoma, Diffuse Large B-cell Lymphoma

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Trial Information

Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line


Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21
regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local
preferences.

Patients can be registered to participate in the study at two time points:

- At time of initial diagnosis and study enrolment (signature of informed consent) before
the first cycle of treatment with R-CHOP.

- At randomization (signature of informed consent) after treatment in first line with
R-CHOP and have reached at least PR or CR.

Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria
for Malignant Lymphoma(2007).

Stratification: Before randomization, the patients will be stratified according to the
country and the response to R-CHOP (PR vs CR).

Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with
lenalidomide or placebo.


Ages Eligible for Study: Between 60 and 80 years old

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Inclusion Criteria:



For patients registered at the time of initial diagnosis

- Patient with histologically proven CD20+ diffuse large B cel LYMPHOMA (DLBCL) 5WHO
classification 2008) including clinical subtypes (primitive mediastinal,
intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma
(Follicular, other..) may also be included. Patients with DLBCL associated with some
small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma
with intermediate features between DLBCL and Burkitt or with intermediate features
between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or
CD20+ Aggressive B-cell lymphoma unclassifiable

- previous untreated with chemo- or radiotherapy

For patients registered after response evaluation to first line treatment with R-CHOP:

- Patient with histologically proven CD20+ diffuse large B cell LYMPHOMA (DLBCL) 5WHO
classification 2008) including clinical subtypes (primitive mediastinal,
intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma
(Follicular, other..) may also be included. Patients with DLBCL associated with some
small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma
with intermediate features between DLBCL and Burkitt or with intermediate features
between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or
CD20+ Aggressive B-cell lymphoma unclassifiable

- Have reached a CR or PR after first line treatment with at least 6 cycles of R-CHOP
14 regimens and up to 8 cycles of R-CHOP21

- Previously untreated with Radiotherapy

For all patients:

- aged from 60 to 80 years at time of registration

- Ann Arbor stages II-IV at time of initial diagnosis

- aaIPI> 1 at time of initial diagnosis

- ECOG performance status 0-2

- Minimum life expectancy of 3 months

- Following laboratory values at screening:

- ANC≥ 1000.10^6/L and Platelets≥60000.10^6/L

- AST<5*ULN, ALT<5*ULN, Total Bilirubin<1,5*ULN

- Creatinine clearance>30mL/min

- Women are are using effective contraception, are not pregnant and agree not to become
pregnant during participation in the trial and after end of study. Men agree not to
father a child during participation in the trial and during the 12 months thereafter.

- Having previously signed a written informed consent form

Exclusion Criteria:

- Any other histological type of Lymphoma, Burkitt included.

- Any history of treated or non treated small B-cell lymphoma

- Central nervous system or meningeal involvement by lymphoma

- Contraindication to any drug contained in the chemotherapy regimen Myocardial
infarction during last 3 months or unstable coronary disease or uncontrolled chronic
symptomatic congestive heart insufficiency NYHA III-IV

- Uncontrolled hypertension

- Uncontrolled diabetes mellitus as defined by the investigator

- Active systemic infection requiring treatment

- previously known HIV positive serology

- Active hepatitis B or C

- Prior history of malignancies other than lymphoma within 3 years

- Serious medical or psychiatric illness

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free-Survival (PFS)

Outcome Description:

PFS will be measured from the date of randomization to the date of first documented disease progression or death.Progression data will be assigned to the earliest time when any progression is observed without prior missing assessments during the study up to the end of the follow up phase.

Outcome Time Frame:

Final PFS analysis will be realized when the number of events (282) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized.

Safety Issue:

No

Principal Investigator

Bertrand COIFFIER, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lymphoma Study Association

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

REMARC

NCT ID:

NCT01122472

Start Date:

April 2009

Completion Date:

August 2017

Related Keywords:

  • Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • lenalidomide (Revlimid)
  • diffuse large B-cell lymphoma
  • phase III study
  • after R-CHOP
  • Maintenance treatment
  • Maintenance
  • Lenalidomide (Revlimid)
  • After R-CHOP
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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