Actively Recruiting
Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
Led by New York Medical College · Updated on 2026-04-15
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies patients with various types of B-cell non-Hodgkin lymphoma and Hodgkin lymphoma who receive autologous stem cell transplant (ASCT) after a conditioning regimen. The purpose is to evaluate the safety and tolerability of adding Polatuzumab Vedotin immunoconjugate therapy after ASCT. Patients must have specific lymphoma diagnoses and either stable or responding disease after prior therapies to participate. Participants first undergo one of two myeloablative conditioning treatments, BEAM or CBV, followed by ASCT on Day 0. Supportive care with sargarmostim and filgrastim is given until blood counts stabilize. If patients achieve complete, partial, or stable response after ASCT, they receive intravenous Polatuzumab Vedotin every 21 days for up to eight doses. After completing Polatuzumab Vedotin therapy, patients are monitored for about two years with follow-up visits every four months. During the study, researchers will monitor safety and tolerability for one year and assess event-free survival, progression-free survival, overall survival, and overall response rates for two years. Evaluations include performance status, organ function tests, and stem cell counts before ASCT. Safety assessments and response evaluations occur throughout treatment, and long-term follow-up monitors patient outcomes. Participation lasts several years including treatment and observation periods.
CONDITIONS
Brief Title
Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of B-cell non-Hodgkin lymphoma or CD20+ Hodgkin lymphoma, including specified subtypes such as Burkitt, Diffuse Large B Cell, Follicular, Mantle Cell, Marginal Zone, Transformed Follicular, and Richter syndrome.
- Disease status of primary induction failure or first through third relapse/progression with complete response, partial response, or stable disease after reinduction therapy.
- Performance status of 50% or greater using Karnofsky scale for patients over 16 years or Lansky scale for 16 years and under.
- Life expectancy greater than 6 weeks.
- Fully recovered from acute toxic effects of prior chemotherapy, immunotherapy, or radiotherapy within specified time frames.
- Adequate renal function defined by creatinine clearance or serum creatinine levels based on age and gender.
- Adequate liver function with total bilirubin and liver enzymes within specified limits.
- Adequate cardiac function with shortening fraction over 27% or ejection fraction over 50%.
- Adequate pulmonary function with normal respiratory rate and oxygen saturation over 94% on room air unless due to lymphoma.
- Peripheral blood stem cell collection with target of 5.0 x 10^6 CD34 cells (minimum 2.5 x 10^6) collected and cryopreserved before conditioning.
- Signed informed consent by patient or legal guardian.
You will not qualify if you...
- Previous stem cell transplant.
- Active central nervous system lymphoma.
- Use of other investigational agents for B-cell lymphoma.
- Pregnancy or active breastfeeding.
- Sexually active patients not agreeing to effective contraception during study participation.
- Uncontrolled infection.
- Grade 3 or higher neuropathy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until completion of up to 8 doses of Polatuzumab Vedotin following ASCT
Participants receive myeloablative conditioning followed by autologous stem cell transplant (ASCT) on Day 0. After recovery and if response criteria are met, participants receive Polatuzumab Vedotin by IV once every 21 days for up to 8 doses.
1 treatment visit every 21 days for up to 8 visits plus supportive care visits as needed
Trial Site Locations
Total: 1 location
1
New York Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
Research Team
L
Lauren Harrison, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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