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

  • STATUS
    Recruiting
  • End date
    Aug 15, 2024
  • participants needed
    20
  • sponsor
    New York Medical College
Updated on 13 November 2021
renal function
oxygen saturation
lymphoma
filgrastim
ejection fraction
nitrosoureas
leukemia
biological factors
chemotherapy regimen
pulse oximetry
follicular lymphoma
cancer chemotherapy
mantle cell lymphoma
marginal zone lymphoma
renal function tests
richter syndrome
diffuse lymphoma

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.

Details
Condition Transformed Non-Hodgkin Lymphoma, hodgkins lymphoma, b cell lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, hodgkin lymphomas, Mantle Cell Lymphoma, Richter's Syndrome, hodgkin, burkitt lymphoma, Richter Syndrome, B-Cell Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma, Burkitt's Lymphoma, diffuse large b cell lymphoma, hodgkin's lymphoma, Diffuse Large B-Cell Lymphoma, MALT Lymphoma, b-cell lymphomas, Lymphoma, B-Cell, hodgkin's lymphomas, b cell lymphomas, Mantle cell lymphoma, Hodgkin's Disease, diffuse large cell lymphoma, Richter's Transformation
Treatment Polatuzumab Vedotin
Clinical Study IdentifierNCT04491370
SponsorNew York Medical College
Last Modified on13 November 2021

Eligibility

Yes No Not Sure

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
Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)
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
to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4
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
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