Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL) MedDRA version: 17.1 Level: HLT Classification code 10002235 Term: Anaplastic large cell lymphomas T- and null-cell types System Organ Class: 100000004851
Conditions
Sponsors
AGMT gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients = 18 years of age • ALK+ ALCL • Histologically confirmed relapse after having achieved a PR or CR with conventional therapy • Refractoriness to conventional chemotherapy (SD or PD after conventional chemotherapy) • Not able to receive conventional chemotherapy (e.g. due to comorbidities) • Adequate organ function, defined as the following: - Absolute neutrophil count = 1,500/µL unless there is known hematologic/solid tumor marrow involvement - Platelet count = 75,000/ µL unless there is known marrow involvement of the disease - Total bilirubin must be 40 mL/minute. - Hemoglobin must be = 8g/dL. • Written, voluntarily signed informed consent • Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, must practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent until 6 months after the last doses of BV and until last doses of imatinib, whatever occurs later, or agrees to completely abstain from heterosexual intercourse. • Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of BV, or agrees to completely abstain from heterosexual intercourse. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Patient has received any other investigational treatment within 28 days before study entry • Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or imatinib • ECOG performance status = 3 • Acute or chronic infections • Female patients who are pregnant or breast-feeding • Known diagnosis of HIV • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection • Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol. • Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML • Symptomatic neurologic disease compromising normal activities of daily living or requiring medications • Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 • Known history of any of the following cardiovascular conditions o Myocardial infarction within 2 years of study entry o New York Heart Association (NYHA) Class III or IV heart failure o Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities o Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% • Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose • Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of simultaneous administration of brentuximab vedotin and imatinib mesylate in substitution of conventional chemotherapeutic treatment.;Secondary Objective: - Clinical response rate (ORR, CR, PR) - Ability to receive further treatment (stem cell transplantation) - Progression-free survival and overall survival - Identification and assessment of biomarkers Apart from clinical response rates with BV and imatinib, it seems important to evaluate, how many patients can go on to stem cell transplantation. sCD30 and PDGF can be determined in blood samples and should be evaluated as biomarkers.;Primary end point(s): Safety and tolerability;Timepoint(s) of evaluation of this end point: after 72 month, at end of study after LVLP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: after 72 month, at end of study after LVLP | — |
Countries
Austria
Contacts
Public ContactClinical Project Manager
AGMT gemeinnützige GmbH
Outcome results
None listed