Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-11

Study Completion Date

2021-11-01

Brief Summary

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A multi-center, open-label, phase Ib study to evaluate the safety and tolerability of the administration of tisagenlecleucel in combination with ibrutinib in patients with r/r DLBCL who have received two or more lines of systemic therapy, including an anti-CD20 and anthracycline based chemotherapy, and who have progressed after or are not candidates for ASCT.

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Detailed Description

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Conditions

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Diffuse Large B-cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

"The study will enroll patients into two arms in parallel: Arm 1: Patients will start ibrutinib treatment before leukapheresis. Arm 2: Patients will start ibrutinib treatment after leukapheresis. Approximately 3-6 patients will be enrolled into each of the two arms in parallel. An early safety review will be performed after these patients have received sufficient ibrutinib treatment and tisagenlecleucel infusion, and have completed at least 21 days of follow up. Additional patients (up to 20 total) will be enrolled into both arms to further characterize the safety, tolerability and preliminary efficacy of ibrutinib in combination with tisagenlecleucel."

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibrutinib (before leukapheresis) + Tisagenlecleucel

Patients will start ibrutinib treatment before leukapheresis

Group Type EXPERIMENTAL

Tisagenlecleucel

Intervention Type BIOLOGICAL

Infusion

Ibrutinib

Intervention Type DRUG

Oral (tablets or capsules)

Ibrutinib (after leukapheresis) + Tisagenlecleucel

Patients will start ibrutinib treatment after leukapheresis.

Group Type EXPERIMENTAL

Tisagenlecleucel

Intervention Type BIOLOGICAL

Infusion

Ibrutinib

Intervention Type DRUG

Oral (tablets or capsules)

Interventions

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Tisagenlecleucel

Infusion

Intervention Type BIOLOGICAL

Ibrutinib

Oral (tablets or capsules)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Confirmed DLBCL as per the local histopathological assessment.
2. Relapsed or refractory disease having received 2 or more lines of systemic therapy, including anti-CD20 and anthracycline based chemotherapy, and either having progressed after (or relapsed after) ASCT, or being ineligible for or not consenting to ASCT.
3. Measurable disease at time of enrollment.
4. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening.
5. Adequate renal, liver, and bone marrow, organ function, and minimum level of pulmonary reserve.

Exclusion Criteria

1. Patients with Richter's transformation, Burkitt's lymphoma, and primary DLBCL of the CNS.
2. Prior anti-CD19 directed therapy.
3. Prior gene therapy.
4. Prior adoptive T cell therapy.
5. Prior ibrutinib therapy within the 30 days prior to screening.
6. Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was \> 4 weeks before enrollment.
7. Prior allogeneic HSCT
8. . Significant cardiac abnormality including history of myocardial infarction within 6 months prior to screening as detailed in the study protocol.

Other eligibility criteria may apply.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No