Actively Recruiting

Phase 1
Phase 2
Age: 12Years - 70Years
All Genders
NCT04491370

Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin 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

315 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with B-cell NHL including Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, or CD20+ Hodgkin Lymphoma
  • Disease status of primary induction failure or 1st to 3rd relapse/progression with complete, partial, or stable response after reinduction therapy
  • Performance status of at least 50% using Karnofsky (over 16 years old) or Lansky (16 years or younger) score
  • Life expectancy greater than 6 weeks
  • Fully recovered from acute toxic effects of prior chemotherapy, immunotherapy, or radiotherapy
  • No myelosuppressive chemotherapy within 2 weeks (4 weeks if prior nitrosourea)
  • At least 7 days since completing biologic (anti-neoplastic) therapy
  • Adequate renal function with creatinine clearance or GFR over 60 mL/min/1.73 m2 or serum creatinine within age and gender limits
  • Adequate liver function with total bilirubin ≤ 1.5 times upper limit of normal and AST/ALT less than 3 times upper limit of normal
  • Adequate cardiac function with shortening fraction over 27% or ejection fraction over 50%
  • Adequate pulmonary function with normal respiratory rate and pulse oximetry over 94% on room air unless due to malignancy
  • Peripheral blood stem cell collection of at least 2.5 x 10^6 CD34 cells (target 5.0 x 10^6) collected and cryopreserved
  • Signed written informed consent by patient or legal guardian
Not Eligible

You will not qualify if you...

  • Prior stem cell transplant
  • Active central nervous system lymphoma
  • Use of other investigational agents for B-cell lymphoma treatment
  • Pregnancy or active breastfeeding
  • Sexually active patients of reproductive potential not using effective contraception during study
  • Uncontrolled infection
  • Neuropathy of grade 3 or higher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

New York Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

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Research Team

L

Lauren Harrison, RN

CONTACT

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