Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Double or Triple Hit Lymphoma
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|ClinicalTrials.gov Identifier: NCT04479267|
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : April 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements High Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 Rearrangements||Drug: Prednisone Drug: Prednisolone Drug: Methylprednisolone Biological: Rituximab Drug: Polatuzumab Vedotin Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Double and Triple Hit Lymphoma|
|Actual Study Start Date :||August 21, 2020|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: Treatment (polatuzumab vedotin, R-CHP)
Patients receive prednisone PO, prednisolone IV, or methylprednisolone IV on days 1-5. Patients also receive rituximab IV, polatuzumab vedotin IV over 30-90 minutes, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Other Name: .delta.1-Cortisone, 1, 2-Dehydrocortisone, 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione, 53-03-2, Adasone, Cortancyl, Dacortin, , Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome
Other Name: (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione, .delta.1-Hydrocortisone, 1,2-Dehydrohydrocortisone, 50-24-8, 9120, Adnisolone, Aprednislon, Capsoid, Cortalone, Cortisolone
Other Name: (6alpha,11beta)-11,17,21-Trihydroxy-6-methylpregna-1,4-diene-3,20-dione, 6Alpha-Methylprednisolone, Adlone, Caberdelta M, DepMedalone, Depo Moderin, Depo-Nisolone, Duralone, Emmetipi, Esametone
Other Name: 174722-31-7, 687451, ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8
Drug: Polatuzumab Vedotin
Other Name: 1313206-42-6, ADC DCDS4501A, Antibody-Drug Conjugate DCDS4501A, DCDS4501A, FCU 2711, POLATUZUMAB VEDOTIN, polatuzumab vedotin-piiq, Polivy, RG7596, Ro 5541077-000
Other Name: 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin monohydrate, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
Drug: Doxorubicin Hydrochloride
Other Name: 14-Hydroxydaunorubicin Hydrochloride, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-
- Rate of complete remission [ Time Frame: Up to 6-8 weeks after cycle 6 day 1 (cycles = 21 days) or last dose of study medication ]Will be assessed by modified Lugano response criteria for malignant lymphoma. The complete remission rate will be summarized by a binomial response rate and its associated 2-sided 80% confidence interval (CI) using Pearson-Klopper method. The primary efficacy analysis will be also performed based on all response evaluable subjects as a sensitivity analysis.
- Incidence of adverse events [ Time Frame: Up to 30 days after last dose of study treatment ]Safety will be assessed through summaries of adverse events, summaries of changes from screening assessments in laboratory test results, electrocardiograms, and changes in vital signs. All adverse events occurring on or after first study treatment will be summarized by mapped term, appropriate thesaurus levels, and National Cancer Institute (NCI) Common Terminology Criteria Adverse Events version (v) 4.03 toxicity grade. All serious adverse events will be listed separately and summarized. Deaths reported during the study treatment period and those reported during follow-up after treatment discontinuation will be listed. Relevant laboratory and vital sign (temperature, heart rate, respiratory rate, pulse oximetry, and blood pressure) data will be displayed by time, with NCI Common Terminology Criteria for Adverse Events v5.0. Grade 3 and 4 values identified where appropriate.
- Progression-free survival (PFS) [ Time Frame: From the start date of the treatment until the date of progression or death from any cause, whichever occurs first, assessed up to 12 months ]The distribution of PFS will be graphically summarized using the Kaplan-Meier (KM) curve and the median PFS and its associated 2-sided CI will be estimated using the KM estimator. The median follow-up time and its 2-sided CI will be estimated using the reverse KM estimator.
- Overall response rate (ORR) [ Time Frame: Up to 12 months ]Will be defined as complete response (CR) or partial response (PR) at primary response assessment based on positron emission tomography/computed tomography as determined by the investigator and assessed using modified Lugano response criteria. CR and PR will be summarized using frequency and percentage. The ORR will be summarized by a binomial response rate and its associated 2-sided CI using Pearson-Klopper method.
- Duration of response (DOR) [ Time Frame: From the date of CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is documented among all treated subjects who had a confirmed CR or PR, assessed up to 12 months ]The distribution of DOR will be graphically summarized using the KM curve and the median PFS and its associated 2-sided CI will be estimated using the KM estimator.
- Biomarker assessment [ Time Frame: Up to time of disease progression, assessed up to 12 months ]Exploratory analyses of biomarkers related to tumor biology and the mechanisms of action of polatuzumab vedotin and rituximab will be conducted. Analyses will assess prognostic and/or predictive value of candidate biomarkers separately for each histological subtype and both investigator and Independent Review Committee assessed outcomes. Specifically, the association between candidate biomarkers and positron emission tomography (PET)-computed tomography (CT) CR rate and objective response rate and potentially other measures of efficacy and safety, independent of treatment, will be explored to assess potential prognostic value. In addition, the potential effect modification of treatment effect on PET-CT CR rate and OR rate and potentially other measures of efficacy and safety, by biomarker status, will be explored to assess potential predictive value.
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): NCT04479267
|Contact: Charles Schiffer, M.D.||(313) email@example.com|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Clinical Trials Office 800-527-6266|
|Sub-Investigator: Asif Alavi, M.D.|
|Sub-Investigator: Abhinav Deol, M.D.|
|Sub-Investigator: Andrew Kin, M.D.|
|Sub-Investigator: Dipenkumar Modi, M.D.|
|Sub-Investigator: Melissa Runge-Morris, M.D.|
|Sub-Investigator: Dahlia Sano, M.D.|
|Sub-Investigator: Erlene Seymour, M.D.|
|Sub-Investigator: Jay Yang, M.D.|
|Sub-Investigator: Jeffrey Zonder, M.D.|
|Principal Investigator: Charles Schiffer, M.D.|
|Principal Investigator:||Charles Schiffer, M.D.||Barbara Ann Karmanos Institute|