EUCTR2012-002542-20-BEActive, not recruitingPhase 1
Efficacy of alternating immunochemotherapy consisting of R-CHOP + R-HAD versus R-CHOP alone, followed by maintenance therapy consisting of additional lenalidomide with rituximab versus rituximab alone for older patients with mantle cell lymphoma
YSARC0 sites633 target enrollmentStarted: May 5, 2014Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 633
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •signed informed consent form
- •Biopsy-proven mantle cell lymphoma according to WHO classification, including evidence of cyclin D1 overexpression or the translocation t(11;14)(q13;q32).
- •= 60 years of age and ineligible for autologous transplant
- •Ann Arbor stage II-IV
- •previously untreated
- •ECOG performance status = 2
- •Male subjects must:
- •- agree to use a condom during sexual contact with a woman of childbearing potential, even if they have had a vasectomy, throughout lenalidomide/placebo therapy
- •- agree to not donate semen during lenalidomide therapy.
- •All subjects must:
- •- have an understanding that the lenalidomide could have a potential teratogenic risk.
- •- agree to abstain from donating blood while taking lenalidomide therapy
- •- agree not to share study medication with another person.
- •- be counseled about pregnancy precautions and risks of fetal exposure.
- •Additional criteria for randomization in maintenance phase :
- •- CR, CRu or PR after induction treatment, determined as per Cheson 1999 criteria by investigator
- •- During the run-in period of 6 months starting from the date of the first patient randomized in the trial: in case of direct randomization into maintenance phase, patient must have been treated in first line by 6-8 cycles of R-CHOP.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 183
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
Exclusion Criteria
- •Female of child-bearing potential (without natural menopause for at least 24 consecutive months, a hysterectomy or bilateral oophorectomy)
- •Any of the following laboratory abnormalities, if not related to lymphoma:
- •- Absolute neutrophils count (ANC) <1,000 /mm3 (1.0 x 109/L) if not result of a BM infiltration.
- •- Platelet count < 75,000/mm3 (75 x 109/L) if not result of a BM infiltration.
- •- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) >3.0 x upper limit of normal.
- •- Serum total bilirubin > 1.5 UNL (except if due to Gilbert’s syndrome)
- •Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) < 30 mL /min.
- •Central nervous system involvement by lymphoma
- •Contraindication for medicamentous DVT prophylaxis
- •Prior history of malignancies other than MCL unless the subject has been free of the disease for = 5 years (Exceptions: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or of the breast, Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b).
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient to receive the study medication as planned.
- •Poor cardiac function (LVEF < 50%) on echecardiography
- •Seropositivity for human immunodeficiency virus (HIV, mandatory test)
- •Seropositivity for hepatitis C virus (HCV, mandatory test),
- •Active viral infection with hepatitis B virus (HBV, mandatory test):
- •- HBsAg positive
- •- HBsAg negative, anti-HBs positive and anti-HBc positive
- •Patients with prior Hepatitis B must be given antiviral prophylaxis and HBV DNA monitored.
- •Note: Patients who are HBsAg negative, anti-HBs positive and/or anti HBc positive but viral DNA negative are eligible.
- •Uncontrolled illness including, but not limited to:
- •- Active infection requiring parenteral antibiotics
- •- Uncontrolled diabetes mellitus
- •- Chronic symptomatic congestive heart failure (Class NYHA III or IV).
- •- Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
- •- Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia.
- •Prior = Grade 3 allergic hypersensitivity to thalidomide.
- •Prior = Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
- •Subjects with = Grade 2 neuropathy.
- •Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
- •Prior use of lenalidomide.
- •Participation in another clinical trial within three weeks before randomization in this study
- •Additional exclusion criteria for randomization in maintenance phase:
- •- SD or PD after induction treatment determined as per Cheson 1999 criteria assessed by investigator.
- •- Patients who had not received at least 6 cycles of R-CHOP21 or 2 cycles of R-CHOP21 / 2 cycles of R-HAD28 (alternating)
- •- Patients with serious underlying medical conditions, which could impair the ability to receive maintenance treatment
- •- Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of < 30 mL /min at screening for maintenance.
- •- ANC < 1,000 cells/mm³ (1.0 X 109/L) at screening for maintenance;
- •- Platelet count < 50,000 cells/mm³ (50 X 109/L) at screening for maintenance.
Investigators
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