Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-008717
NCT ID: NCT01979536
Sponsor Protocol Number: ANHL12P1
About this study
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Newly diagnosed patients with histologically proven anaplastic large cell lymphoma (ALCL) (International Classification of Diseases for Oncology [ICD-0] code: 9714/3)
- Disease must be cluster of differentiation (CD)30 positive
- Disease must be anaplastic lymphoma kinase (ALK) positive (defined by local institutional standards)
- Patients must have stage II, III, or IV disease
- Patients must have a life expectancy of ≥ 8 weeks
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
- Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x upper limit of normal (ULN) for age; for the purpose of this study, the ULN for ALT is 45 U/L
- If the lab abnormality is thought to be due to the lymphoma the patient is eligible and dose adjustments should be made
- Shortening fraction of ≥ 27% by echocardiogram, or
- Ejection fraction of ≥ 50% by radionuclide angiogram
- Patients with a history of pulmonary dysfunction must have no evidence of dyspnea at rest, no exercise intolerance due to pulmonary insufficiency, and a pulse oximetry ≥ 92% while breathing room air unless current dysfunction is due to the lymphoma in which case the patient is eligible
- Patients with central nervous system (CNS) disease are not eligible
- Patients with disease limited to the skin are not eligible, regardless of how wide-spread
- Patients with stage I disease are not eligible
- Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously are not eligible
- Previous steroid treatment and/or radiation treatment is not allowed unless it is for the emergent management of a mediastinal mass
- Intrathecal chemotherapy prior to enrollment will not be allowed for the current diagnosis of ALCL unless the cerebrospinal fluid (CSF) is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL
- Female patients who are pregnant are not eligible; pregnancy tests must be obtained in girls who are post menarchal
- Lactating females are not eligible unless they have agreed not to breastfeed their infants
- Sexually active patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of treatment and for 3 months after stopping treatment
- Patients with Down syndrome are not eligible
- Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients are not eligible
- Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) substrates with narrow therapeutic indices: Patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices including pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible
- CYP3A4 inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin, many non-nucleoside reverse transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible
- CYP3A4 inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 12 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible
- Patients positive for human immunodeficiency virus (HIV) are not eligible; note: inclusion of HIV positive patients will be considered at a later date
- Patients who weigh < 10 kg are not eligible
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Carola A Arndt, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office