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

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ClinicalTrials.gov Identifier: NCT04856137
Recruitment Status : Not yet recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
China Medical University Hospital
Shin Kong Wu Huo-Shih Memorial Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Refractory Diffuse Large B-cell Lymphoma Drug: Rituximab Paclitaxel Ruxolitinib Phase 1 Phase 2

Detailed Description:

This is an open-label, single arm, prospective, multiple-center phase Ib/II study.

In phase Ib, a maximum of 18 patients will be enrolled in the dose-finding period to determine the RP2D, dependent on the toxicity of the study drugs. The response rates of salvage chemotherapy regimen in R/R DLBCL were reported to be within the range of 35-65%.3 Assuming that the response rate of traditional salvage therapy has an overall response rate of 35% (H0=0.35) and that our experimental regimen would increase it to 50% (H1=0.50), the estimated sample size according to the Simon's two-stage minimal design will be 49 in the second phase.1 Briefly, among the 31 patients recruited during the first stage, the response should be seen in at least 10 of the cases, the lowest threshold for the trial to be moved into the second stage of the phase II part. Furthermore, for the RPR regimen to be deemed effective, a response must be demonstrated in at least 21 of the whole 49 patients enrolled in the phase II period. This would achieve a power of 80%, with a two-sided type I error rate of 10%. An additional 7 patients will be recruited, for an estimated dropout rate of 10%.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Relapse/Refractory Diffuse Large B-cell Lymphoma
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: single arm
ruxolitinib, paclitaxel, and rituximab
 Drug: Rituximab Paclitaxel Ruxolitinib
Rituximab 375mg/m2 on D1 of each cycle Paclitaxel 200mg/m2 on D1 of each cycle Ruxolitinib continuously given (D1-21)
Other Name: G-CSF 1PC sc qd


Outcome Measures
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Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: 1 year ]
    The tumor response will be assessed according to IWG Response Criteria.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who have prior treatment with ruxolitinib or taxane for DLBCL.
  2. Pregnant or breast-feeding females.
  3. Active or uncontrolled infection.
  4. Life expectancy < 6 months
  5. Patients with brain or leptomeningeal metastases.
  6. Known hypersensitivity to ruxolitinib or paclitaxel
  7. Grade III peripheral neuropathy secondary to prior to therapy
  8. Second malignancy, except indolent cancers not on active anti-cancer therapy.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04856137


Contacts
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Contact: Chih-Cheng Chen, M.D. Ph.D. 886-5-3621000 ext 2852 ccchen1968@gmail.com
Contact: Hui-Jen Tsai, M.D. Ph.D. 886-6-7000123 ext 65149 hjtsai@nhri.edu.tw

Sponsors and Collaborators
National Health Research Institutes, Taiwan
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
China Medical University Hospital
Shin Kong Wu Huo-Shih Memorial Hospital
More Information
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Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT04856137    
Other Study ID Numbers: T1420
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Paclitaxel
 Rituximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents