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

October 24, 2023 updated by: New York Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Medical College

Investigators

  • Principal Investigator: Aliza Gardenswartz, MD, 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 Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14357

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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