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

Brief Title

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

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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Safety and tolerability

Secondary Outcome

 EFS, PFS, and OS

Condition

B-cell Lymphoma

Intervention

Polatuzumab vedotin

Study Arms / Comparison Groups

 Polatuzumab vedotin

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

August 1, 2021

Completion Date

August 15, 2024

Primary Completion Date

August 15, 2023

Eligibility 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.
      

Gender

All

Ages

12 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Aliza Gardenswartz, MD, 6172857844, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04491370

Organization ID

14357

Responsible Party

Sponsor

Study Sponsor

New York Medical College

Study Sponsor

Aliza Gardenswartz, MD, Principal Investigator, New York Medical College

Verification Date

October 2021