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Autologous Stem Cell Transplant with Polatuzumab Vedotin for Lymphoma

This study is looking at the safety and tolerability of a treatment plan for people with certain types of B-cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma. You might be able to join if you are between 12 and 70 years old and have specific types of lymphoma that have not responded well to initial treatment or have returned. The treatment involves an autologous stem cell transplant (ASCT), where your own healthy stem cells are given back to you after high-dose chemotherapy. If your lymphoma responds well to the ASCT, you will then receive a drug called Polatuzumab Vedotin through an IV every 21 days for a total of 8 doses. The study aims to see how well people tolerate this treatment over one year. The current recruitment status is unclear, and the study plans to enroll 20 participants.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
You will receive high-dose chemotherapy followed by an autologous stem cell transplant. If your disease responds, you will then receive 8 doses of Polatuzumab Vedotin intravenously every 21 days.
Compensation
Not stated in the trial record.
Follow-up
After Polatuzumab Vedotin therapy is completed, you will be followed every 4 months for about 2 years.

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NCT04491370

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

Recruiting
PHASE1Ages 12–70InterventionalTreatment
New York Medical College
~20 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Polatuzumab vedotin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability
Measured over 1 year

Conditions

B-cell Lymphoma
Burkitt Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Transformed Non-Hodgkin Lymphoma
Richter Syndrome
Hodgkin Lymphoma

Explore related trials

B-Cell Non-Hodgkin LymphomaBurkitt LymphomaDiffuse Large B-Cell LymphomaFollicular LymphomaHodgkin's GranulomaMantle Cell LymphomaMarginal Zone LymphomaRichter SyndromeTransformed Non-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
New York1

Who to contact

Lauren Harrison, RN
[email protected]
6172857844
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Organ Function Requirements
Creatinine clearance or radioisotope GFR \> 60 mL/min/1.73 m2 or
A serum creatinine based on age/gender as follows:
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:
Peripheral Blood Stem Cell Collection
All patients and/or their parents or legal guardians must sign a written informed consent.

Exclusion

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.

What this trial measures

  • Safety and tolerability1 year

    To evaluate the safety and tolerability of Polatuzumab vedotin (PV) immunoconjugate therapy post myeloablative conditioning (MAC) and autologous stem cell transplantation (AutoSCT) in patients with B-cell non-Hodgkin lymphoma (NHL). Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0. To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to polatuzumab vedotin.