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A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type)

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Trial Information

A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)


To assess benefit and safety of lenalidomide in patients with refractory or relapsing
primary cutaneous large B-cell lymphoma leg type (PCBCL-LT) after a first line treatment by
Rituximab and polychemotherapy. The primary endpoint is overall response rate (complete
response and partial response) at 6 months. Response will be assessed according to clinical
and isotopic criteria.

Optional biological study:

A biological collection (skin and blood samples) will be established. Predictive biological
markers of response or of aggressiveness and resistance to the treatment will be
investigated on the skin biopsies by phenotypic and genetic analyses. The recent discovery
of BLIMP1 inactivation or deletion at 6q21 in activated B-cell like type of diffuse large
B-cell systemic lymphoma points to the need of both a global genetic analysis by Array-CGH
with Single Nucleotide Polymorphism study and a specific investigations of the status of
genes such as CDKN2A, BCL2, BCL6 and BLIMP1 by FISH analysis and/or gene dosage. Xenograft
will be performed from skin biopsies in order to develop animal models for PCLBCL-LT.

Lenalidomide stimulates NK cells immunity and enhances anti-tumor responses. It also seems
to modify the phenotype of NK cells through a decrease of the expression of Killer cell
Immunoglobulin-like Receptors and NKp46. The expression of the NK receptors on blood cells
will be analyzed in order to evidence modifications of the phenotypical and functional
changes under treatment, and to search for a correlation with the clinical response to the
treatment.


Inclusion Criteria:



- Biopsy-proven Primary cutaneous large B-cell lymphoma leg-type

- Clinically measurable skin involvement (T1-T3) or skin and nodal (N1-N3) involvement
measurable by PET-CT, corresponding to :

Relapse after initial complete response (CR) after R-polychemotherapy Or Partial response
or stable disease after R-polychemotherapy

- Age > 18 years

- Life expectancy > 3 months

- WHO performance status 0-2

- Skin biopsy performed at the inclusion on a skin tumor : new tumor in case of
relapsing PCLBCL-LT or initial skin tumor refractory to the previous treatment

- Signed informed consent for clinical and biological analyses. The Lenalidomide
Information Sheet will be given to each patient receiving lenalidomide study therapy.
The patient must read this document prior to starting lenalidomide study treatment
and each time they receive a new supply of study drug.

- Social security cover

- Conditions of global RPP have to be fulfilled by all the patients

- The Lenalidomide Education and Counseling Guidance Document must be completed and
signed by either a trained counselor or the Investigator at the participating
clinical center prior to each dispensing of lenalidomide study treatment. A copy of
this document must be maintained in the patient records.

Exclusion Criteria:

- Central nervous system involvement (cerebral CT scan is performed at the inclusion)

- One or more of the biological abnormalities :

Neutrophil count < 1,500/mm3 ; Platelet count < 60,000/mm3 ; Transaminases > 5 x upper
limit of normal ; Total bilirubin > 2.0 mg/dl (34 µmol/L)/ conjugated bilirubin>0.8 mg/dL,
except of haemolytic anemia ; Creatinine clearance < 50 mL /min ( measured or calculated
according to the method of Cockcroft-Gault)

- Pregnant or lactating females, potentially childbearing females defined by sexually
mature female who: 1) has not undergone a hysterectomy (the surgical removal of the
uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has
not been naturally postmenopausal (amenorrhea following cancer therapy does not rule
out childbearing potential) for at least 24 consecutive months (i.e., has had menses
at any time during the preceding 24 consecutive months.

- Patients should not receive steroids continuously except for prednisone for tumoral
flare treatment

- Uncontrolled infectious and thromboembolic diseases

- Subjects not willing to take deep venous thrombosis prophylaxis

- Prior history of malignancies unless the subject has been free of the disease for ≥5
years. Exceptions include basal cell skin carcinoma, carcinoma in situ of the cervix
or of the breast

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Known seropositive for or active viral infection with HIV, Hepatitis B and C virus.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection requiring parenteral antibiotics, uncontrolled diabetes mellitus as defined
by the investigator

- Chronic symptomatic congestive heart failure (III or IV of the NYHA Classification
for Heart Disease)

- Unstable angina pectoris, angioplasty or myocardial infarctions within 6 months

- Clinically significant cardiac arrhythmia that is symptomatic or requires treatment,
or asymptomatic sustained ventricular tachycardia.

- Prior ≥ Grade 3 allergic reaction/hypersensitivity or desquamative rash while taking
thalidomide

- Any standard or experimental anti-cancer drug therapy or radiation within 3 weeks of
the initiation of study drug therapy.

- Participation in another clinical trial

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete response CR and partial response PR) at 6 months

Outcome Description:

Response will be assessed according to clinical and isotopic criteria.

Outcome Time Frame:

6 months after study treatment start

Safety Issue:

Yes

Principal Investigator

Adelaïde DOUSSAU, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Bordeaux, USMR

Authority:

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

Study ID:

CHUBX 2011/28

NCT ID:

NCT01556035

Start Date:

July 2012

Completion Date:

July 2015

Related Keywords:

  • Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type)
  • oncodermatology
  • hematology
  • cutaneous B cell lymphoma
  • lenalidomide
  • Lymphoma
  • Lymphoma, B-Cell

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