Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an
 autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or
 stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once
 every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed,
 patients will be followed every 4 months for about 2 years.
Inclusion Criteria:

 -  Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular
 Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular
 Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma.

 -  Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse/progression having
 attained a CR, PR, or stable disease post reinduction therapy.

 -  Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for
 patients > 16 years of age and Lansky for patients less than or equal to 16 years of
 age. See Appendix I for performance score.

 -  Life Expectancy Patients must have a life expectancy of > 6 weeks.

 -  Prior Therapy Patients must have fully recovered from the acute toxic effects of all
 prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

 1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry
 onto this study (4 weeks if prior nitrosourea).

 2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy
 with a biologic agent.

 -  Organ Function Requirements

 Adequate Renal Function Defined As:

 -  Creatinine clearance or radioisotope GFR > 60 mL/min/1.73 m2 or

 -  A serum creatinine based on age/gender as follows:

 Age Maximum Serum Creatinine (mg/dL) Male Female

 -  12 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4

 -  16 years 1.7 1.4

 -  Adequate Liver Function Defined As:

 -  Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for
 age, and

 -  SGOT (AST) or SGPT (ALT) < 3 x upper limit of normal (ULN) for age for
 presumed hepatic leukemia or lymphoma.

 -  Adequate Cardiac Function Defined As:

 -  Shortening fraction of > 27% by echocardiogram, or

 -  Ejection fraction of > 50% by radionuclide angiogram.

 -  Adequate Pulmonary Function Defined As:

 • Normal respiratory rate for age and a pulse oximetry > 94% on room air unless
 due to underlying malignancy.

 -  Peripheral Blood Stem Cell Collection

 • Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC
 collected and cryopreserved prior to start of myeloablative conditioning

 -  All patients and/or their parents or legal guardians must sign a written informed
 consent.

 Exclusion Criteria:

 -  Patient may not have had a prior stem cell transplant

 -  Patients must not have active CNS lymphoma

 -  Other concurrent investigational agents for treatment of B-cell lymphoma

 -  Pregnancy and/or active Breast Feeding

 -  Sexually active patients of reproductive potential are not eligible unless they have
 agreed to use an effective contraceptive method for the duration of their study
 participation.

 -  Patient must not have an uncontrolled infection.

 -  Patient must not have ≥ Grade 3 neuropathy.