Lenalidomide in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma Leg-type : Multicentre Prospective Phase II Single Arm Trial of the French Study Group of Cutaneous Lymphoma

NCT01556035 | Completed Phase 2 DMC

• 1 other identifier: CHUBX 2011/28
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 24

Brief Summary

In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients. If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

Conditions

Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type)

Keywords

oncodermatology; hematology; cutaneous B cell lymphoma; lenalidomide

Outcome Measures

Primary Outcomes (1)

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

  Response will be assessed according to clinical and isotopic criteria.

  6 months after study treatment start

Secondary Outcomes (6)

• Overall response rate (complete response CR and partial response PR) at 12 months

  12 months after study treatment start

• Duration of response

  Every 6 months

• Progression-free survival

  Every 6 months

• Overall survival and disease specific survival

  Evrey 6 months

• Safety : description of adverse events occured including grade based on CTCAE v4.0

  Monthly during treatment duration (up to 12 months)

Study Arms (1)

Lenalidomide treatment

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Patient orally treated with lenalidomide 25 mg daily for 21 days with 7 days rest of a 28 days cycle.Treatment maintained for 12 months unless progression

Lenalidomide treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (24)

CHU Amiens, Hôpital Sud

Amiens, 80054, France

Location

CHU Besançon, Hôpital Saint-Jacques

Besançon, 25030, France

Location

AP-HP Hôpital Avicenne

Bobigny, 93009, France

Location

AP-HP Hôpital Ambroise Paré

Boulogne-Billancourt, 92104, France

Location

CHU de Clermont-Ferrand, Estaing

Clermont-Ferrand, 63003, France

Location

AP-HP Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon, Le Bocage

Dijon, 21079, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

CHU de Lille Hôpital Claude Huriez

Lille, 59037, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

AP-HM Hôpital Nord

Marseille, 13915, France

Location

CHRU de Montpellier Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHU de Nantes, Hôtel Dieu

Nantes, 44093, France

Location

CHU de Nice Groupe hospitalier l'Archet

Nice, 06202, France

Location

AP-HP- Hôpital Saint Louis

Paris, 75475, France

Location

AP-HP Groupe hospitalier Cochin

Paris, 75679, France

Location

AP-HP Groupe hospitalier Bichat - Claude Bernard

Paris, 75877, France

Location

AP-HP Hôpital Tenon

Paris, 75970, France

Location

CHU de Bordeaux Hôpital du Haut Lévèque

Pessac, 33604, France

Location

CHU Lyon Sud

Pierre-Bénite, 69450, France

Location

CHU de Reims, Hôpital Robert Debré

Reims, 51092, France

Location

CHU de Rouen, Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHU de Toulouse Hôpital Larrey

Toulouse, 31059, France

Location

CHU de Tours- Hôpital Trousseau

Tours, 37044, France

Location

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Marie BEYLOT-BARRY, MD-PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Eric FRISON, MD

  Unité de Soutien Méthodologique à la Recherche clinique et épidémiologique; University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 16, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (24)