A Phase I/II Study of Diffuse Large B-cell Lymphoma

NCT04856137 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: T1420
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

For continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Differences between groups will be calculated using the log-rank test for univariate analysis. Cox's proportional hazards model will be employed to test independent prognostic factors. All calculations will be performed using the Statistical Package of Social Sciences software, version 17.0 (SPSS, Inc., Chicago, IL, USA). The level of statistical significance will be set at 0.05 for all tests.

Conditions

Refractory Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  The tumor response will be assessed according to IWG Response Criteria.

  1 year

Study Arms (1)

single arm

EXPERIMENTAL

ruxolitinib, paclitaxel, and rituximab

Drug: Rituximab Paclitaxel Ruxolitinib

Interventions

Rituximab Paclitaxel Ruxolitinib DRUG

Rituximab 375mg/m2 on D1 of each cycle Paclitaxel 200mg/m2 on D1 of each cycle Ruxolitinib continuously given (D1-21)

Also known as: G-CSF 1PC sc qd

single arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed/refractory CD20+ diffuse large B-cell lymphoma.
• Age greater than 20 years and younger than 75 years old.
• Measurable disease
• Patients must have an ECOG performance status of less than or equal to 2.
• Patients must have recovered from toxic effects of all prior therapy before entering onto study.
• A treatment of drug-free interval of at least 3 weeks since the last dose of chemotherapy is required.
• More than 4 weeks since prior radiotherapy is required.
• Adequate bone marrow function
• Adequate renal function with calculated glomerular filtration rate \> 15 mL/min
• Patients must have adequate liver function
• All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.

You may not qualify if:

• Patients who have prior treatment with ruxolitinib or taxane for DLBCL.
• Pregnant or breast-feeding females.
• Active or uncontrolled infection.
• Life expectancy \< 6 months
• Patients with brain or leptomeningeal metastases.
• Known hypersensitivity to ruxolitinib or paclitaxel
• Grade III peripheral neuropathy secondary to prior to therapy
• Second malignancy, except indolent cancers not on active anti-cancer therapy.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator
• China Medical University Hospital: collaborator
• Shin Kong Wu Huo-Shih Memorial Hospital: collaborator

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chih-Cheng Chen, M.D. Ph.D.

CONTACT

886-5-3621000; ccchen1968@gmail.com

Hui-Jen Tsai, M.D. Ph.D.

CONTACT

886-6-7000123; hjtsai@nhri.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase Ib Dose Escalation All patients received: Rituximab 375mg/m2 on D1 of each cycle, and Paclitaxel 200mg/m2 on D1 of each cycle, plus, G-CSF 1PC sc qd, starting D7 until ANC recovery Ruxolitinib continuously given (D1-21) in the following dose schema Phase II Efficacy Study All patients received: Rituximab 375mg/m2 on D1 of each cycle, and Paclitaxel 200mg/m2 on D1 of each cycle, plus Ruxolitinib using RP2D daily on D1-21 G-CSF 1PC sc qd, starting D7 until ANC recovery Repeat every 21 days

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: April 23, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share