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Protocol No. ANHL12P1

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

Title A Randomized Phase II Trial of Brentuximab Vedotin or Crizotinib in combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Large Cell Lymphoma (ALCL) (IND#117117)

Objective We are testing experimental drug combinations by adding brentuximab vedotin or crizotinib to standard chemotherapy in the hopes of finding a more effective treatment for ALCL. Brentuximab vedotin has been approved by the FDA for the treatment of subjects with Hodgkin lymphoma and subjects with ALCL when other treatments have been tried and are no longer working. For this study, brentuximab vedotin is an experimental drug because it has not been given with other chemotherapy at the same time in children with ALCL.
Brentuximab vedotin is a drug known as an antibody-drug conjugate (ADC) which means it is a combination of two parts. The first part is an antibody (a man-made version of an immune system protein) that finds a protein called “CD30” found on the surface of most the lymphoma (cancer) cells. The second part is a chemotherapy (anti-cancer) drug that stops the cancer cell from dividing (which gets rid of it). Brentuximab vedotin uses the antibody part to find the cancer cells and then kills the cancer cell with the chemotherapy part. Lymphoma expresses a protein called Anaplastic Lymphoma Kinase (ALK). The ALK protein is thought to be a major cause of your type of lymphoma. Crizotinib is a drug which works directly on ALK to kill the cancer cell. Crizotinib has been shown to work against ALCL in a small number of patients after other treatments have not worked. Crizotinib is considered an experimental drug because it has not been given with other chemotherapy at the same time in children with ALCL. We are using crizotinib because it potentially targets one of the main causes of ALCL. But there is a lot that we do not know about crizotinib yet.

Treatment Prophase chemotherapy plus brentuximab vedotin or crizotinib

Description Phase II randomized study with prophase chemotherapy plus brentuximab vedotin or crizotinib

Key Eligibility
  • Patient must be < 22 years of age at the time of study enrollment. Diagnosis
  • Newly diagnosed patients with histologically proven ALCL
  • Disease must be CD30 positive.
  • Disease must be ALK positive (defined by local institutional standards).
  • Patients must have Stage II, III, or IV disease
  • adequate liver function, cardiac function and pulmonary function
  • No CNS disease
  • Patients with disease limited to the skin are not eligible, regardless of how wide-spread
  • 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 is allowed for the current diagnosis of ALCL as long as adequate CSF is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL
  • Can not be pregnant or breast feeding
  • Males and Females must use effective contraceptive
  • Patients with Down syndrome are not eligible due to the amount of methotrexate and potential for side effects
  • Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients are not eligible
  • Can not be HIV positive
  • Can not weigh less than 10 kg

  • Applicable Disease Sites Lymphoma

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics