Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma

Launched by NEW YORK MEDICAL COLLEGE · Jul 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with certain types of B-cell lymphomas and Hodgkin lymphoma. Participants will first undergo a procedure called autologous stem cell transplant (ASCT), where their own stem cells are used to help restore their bone marrow after high-dose chemotherapy. Depending on their response to the transplant, they may then receive a medication called Polatuzumab Vedotin through an IV every 21 days for a total of eight doses. The aim is to see if this combination can improve treatment outcomes for patients.

To be eligible for this trial, patients must have specific types of B-cell lymphomas or Hodgkin lymphoma and should be experiencing their disease's recurrence or progression after initial treatment. They also need to have a good overall health status and meet certain organ function requirements. Participants can expect regular follow-up visits for about two years after completing the treatment to monitor their health. It's important to note that patients who are pregnant, have active infections, or have had certain previous treatments may not qualify for the trial.

Gender

ALL

Eligibility criteria

• 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.