ANHL12P1, A Randomized Phase II study of Brentuximab Vedotin (NSC# 749710) and Crizotinib (NSC# 749005) in Patients with Newly Diagnosed Anaplastic Large Cell Lymphoma (ALCL) IND #117117
- Children’s Medical Center (Dallas, Plano, Southlake)
Martha Pacheco, M.D.
Patients will be randomly assigned with equal probability to one of the studys treatment arms. neither the doctor nor the patient will be able to choose which regimen is received. eligibility restrictions and the use of stratification will ensure that similar patient populations are being compared, and the number of patients required for the study (140) will increase the certainty that any differences in outcome or side effects are indeed due to the type of treatment they received.
There are two exceptions to randomization:
1. if a participant's height and weight are such that the body surface area (BSa) is less than 0.9 m2 then they will be non-randomly assigned to arm BV because crizotinib is only available in strengths which would be too much medicine for them.
2. if one arm is temporarily closed (e.g. to evaluate for toxicity), then the participant will be non-randomly assigned to the other arm.
arm BV: Standard chemotherapy drugs plus brentuximab vedotin.
arm CZ: Standard chemotherapy drugs plus crizotinib.
* Patients must be less than 22 years of age a the time of study enrollment
* Patients must be newly diagnosed with histologically proven ALCL. Disease must be CD30 positive, ALK positive, and patients must have Stage II, II, or IV disease.
* Patients must be expected to live at least 8 weeks or more
* Previous steroids and/or radiation for emergent management of mediastinal mass will be allowed
* Intrathecal chemotherapy prior to enrollment will be allowed for the current diagnosis of ALCL as long as CSF is obtained prior and is negative for ALCL.
* Patients must have adequate organ function as defined in the protocol