relapsed or refractory Hodgkin Lymphoma MedDRA version: 20.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Afinitor 2,5mg
Product Name: everolimus
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Sponsors
University of Cologne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed early or late first relapsed classical HL (CR or CRu ? 3 months following the end of any polychemotherapy regimen +/- radiotherapy); patients with refractory HL (CR or CRu = 3 months following the end of first line treatment); patients with multiple relapse (any salvage therapy, no prior HDCT or SCT); pathology report based on original tumor tissue/lymph node is acceptable for meeting inclusion criteria, but tumor tissue (slides/block) must be available to be sent for central pathology to confirm diagnosis. • Age at entry: 18-60 years. • WHO activity index = 2 • Life expectancy of > 3 months with treatment. • Absolute Neutrophil Count (ANC) = 1.0 x 109/L, platelets = 100 x 109/L, except for HL-related reduced values (e.g. in case of splenomegaly) • Total bilirubin = 2 x ULN (if >2 x ULN direct bilirubin is required and should be =1.5 x ULN) • Serum creatinine = 2 x ULN • Normal organ function (except HL-related) • Patient has given his/her written informed consent to participate in the trial • Patient agrees to his personal data and tissue material, with due regard for data protection, being used for the study. • Women of childbearing potential must have had a negative serum pregnancy test. • Patients capable of swallowing intact study medication tablets and following directions regarding taking study drug, or have a daily caregiver who will be responsible for administering study drug. 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 73 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Liver disease as indicated by ASAT = 3 x ULN (= 5 x ULN if liver involvement is present) • Patients who have a history of another primary malignancy = 3 years, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of uterine cervix. • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable. • Patients unwilling to or unable to comply with the protocol. • Patients who are using other investigational agents or who had received investigational drugs = 4 weeks prior to study drug start. • Patients who had myelosuppressive chemotherapy or biologic therapy 2.0 x ULN • Patients with a known history of HIV seropositivity, chronic active hepatitis • Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: – unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction = 6 months prior to first study drug, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents = 6 months before study drug start – severely impaired lung function as defined by spirometry (FEV1) and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air – any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study – nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities whose thyroid function cannot be maintained in the normal range by medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PHASE I: Primary: • To identify the RPTD (recommended phase II dose) of RAD001 in combination with DHAP (Ever-DHAP) PHASE II: Primary: • To demonstrate the efficacy of Ever-DHAP as induction therapy ;Secondary Objective: PHASE I: Secondary: • To assess toxicity and efficacy of Ever-DHAP PHASE II: Secondary: • To compare efficacy and feasibility of Ever-DHAP and Placebo-DHAP ;Primary end point(s): PHASE I: Primary: • The rate of patients experiencing DLTs during 2 cycles of the combination therapy PHASE II: Primary efficacy endpoint: • CR rate after induction therapy (CT-based only) ;Timepoint(s) of evaluation of this end point: Phase I: During therapy Phase II: After 2 cycles of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PHASE I: Secondary: • Adverse events during combination therapy • Tumor related results of therapy or death • Treatment administration (dose reductions of chemotherapy, duration of treatment) • Time to recovery after end of treatment • Stem cell mobilization PHASE II: Secondary efficacy endpoints: • CT-based tumor status after induction therapy • PET/CT-based tumor status after induction therapy • Progression free survival (PFS) • Overall Survival (OS) ;Timepoint(s) of evaluation of this end point: Phase I: During and directly after therapy Phase II: Restaging after therapy and follow-up of two years | — |
Countries
Germany
Outcome results
None listed