Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04491370
Recruitment Status : Recruiting
First Posted : July 29, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
New York Medical College

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: Polatuzumab vedotin Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 15, 2023
Estimated Study Completion Date : August 15, 2024


Arm Intervention/treatment
Experimental: Polatuzumab vedotin

Evaluable patients for safety Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety.

Evaluable patients for response Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable.

Evaluable patients for EFS, PFS, OS All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS.

Drug: Polatuzumab vedotin
All patients will receive a myeloablative conditioning regimens (BEAM or CBV, as selected by the treating physician) followed by autologous stem cell transplant (ASCT). All patients on this study will receive an autologous stem cell transplant (ASCT) on Day 0 followed by supportive care including the drugs sargarmostim and filgrastim until blood counts are stable. If a complete, partial, or stable response is achieved following ASCT, the patient will receive an IV dose of Polatuzumab Vedotin once every 21 days until he/she receives 8 doses.




Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 1 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.



Secondary Outcome Measures :
  1. EFS, PFS, and OS [ Time Frame: 2 years ]

    To measure event free survival (EFS), progression free survival (PFS) and overall survival (OS) in patients with B-cell NHL following MAC and AutoSCT and post AutoSCT PV maintenance therapy.

    All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII) for patients > 21 years of age.


  2. ORR [ Time Frame: 2 years ]

    To measure overall response rate (ORR) of PV in B-cell NHL patients who are in PR or SD post MAC AutoSCT.

    Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable. EFS, PFS and OS will utilize Kaplan Meier product limit curve method. Response will be defined for patients with non-Hodgkin's lymphoma who had either measurable or detectable disease at the time of study entry in accordance with the revised IPNHL response criteria (Appendix VI,[24]) for patients ≤ 21 years of age and with the Lugano classification (Appendix VII, [25]) for patients > 21 years of age.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04491370


Contacts
Layout table for location contacts
Contact: Lauren Harrison, RN 6172857844 lauren_harrison@nymc.edu

Locations
Layout table for location information
United States, New York
New York Medical Center Recruiting
Valhalla, New York, United States, 10595
Contact: Aliza Gardenswartz, MD       aliza.gardenswartz@wmchealth.org   
Sponsors and Collaborators
New York Medical College
Investigators
Layout table for investigator information
Principal Investigator: Aliza Gardenswartz, MD New York Medical College
Layout table for additonal information
Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT04491370    
Other Study ID Numbers: 14357
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Burkitt Lymphoma
Lymphoma
Lymphoma, B-Cell
Hodgkin Disease
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections