RECRUITING

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

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Conditions

B-cell LymphomaBurkitt LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaTransformed Non-Hodgkin LymphomaRichter SyndromeHodgkin Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma

Quick Facts

Study Start:2021-08-01
Study Completion:2025-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04491370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse/progression having attained a CR, PR, or stable disease post reinduction therapy.
  3. * 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.
  4. * Life Expectancy Patients must have a life expectancy of \> 6 weeks.
  5. * Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  6. 1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea).
  7. 2. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.
  8. * Organ Function Requirements
  9. * Creatinine clearance or radioisotope GFR \> 60 mL/min/1.73 m2 or
  10. * A serum creatinine based on age/gender as follows:
  11. * 12 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
  12. * 16 years 1.7 1.4
  13. * Adequate Liver Function Defined As:
  14. * Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and
  15. * SGOT (AST) or SGPT (ALT) \< 3 x upper limit of normal (ULN) for age for presumed hepatic leukemia or lymphoma.
  16. * Adequate Cardiac Function Defined As:
  17. * Shortening fraction of \> 27% by echocardiogram, or
  18. * Ejection fraction of \> 50% by radionuclide angiogram.
  19. * Adequate Pulmonary Function Defined As:
  20. * Peripheral Blood Stem Cell Collection
  21. * All patients and/or their parents or legal guardians must sign a written informed consent.
  1. * Patient may not have had a prior stem cell transplant
  2. * Patients must not have active CNS lymphoma
  3. * Other concurrent investigational agents for treatment of B-cell lymphoma
  4. * Pregnancy and/or active Breast Feeding
  5. * 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.
  6. * Patient must not have an uncontrolled infection.
  7. * Patient must not have ≥ Grade 3 neuropathy.

Contacts and Locations

Study Contact

Lauren Harrison, RN
CONTACT
6172857844
lauren_harrison@nymc.edu

Principal Investigator

Aliza Gardenswartz, MD
PRINCIPAL_INVESTIGATOR
New York Medical College

Study Locations (Sites)

New York Medical Center
Valhalla, New York, 10595
United States

Collaborators and Investigators

Sponsor: New York Medical College

  • Aliza Gardenswartz, MD, PRINCIPAL_INVESTIGATOR, New York Medical College

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01
Study Completion Date2025-08-15

Study Record Updates

Study Start Date2021-08-01
Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • 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