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Diffuse Large B Cell Lymphoma RelapsedPhase 1/2NCT02142049

Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Phase 1/2 study testing Ibrutinib, DA-EPOCH-R and Lenalidomide in people with Diffuse Large B Cell Lymphoma Relapsed and Diffuse Large B Cell Lymphoma Refractory, run by Pharmacyclics LLC. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ibrutinib, DA-EPOCH-R and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
10 sitesUnited States
Study dates
May 2014to Aug 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Major inclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Pathologically confirmed relapsed/refractory DLBCL
  • Subjects must have ≥1 measurable disease site on CT scan (≥ 1.5 cm in longest dimension).
  • Adequate hepatic and renal function:
  • AST or ALT ≤2.5 x ULN
  • Serum Creatinine ≤ 2.0 mg/dL and creatinine clearance ≥60 mL/min/1.73
  • Bilirubin ≤1.5 x ULN
  • Adequate hematologic function:
  • ANC >1,000 cells/mm3
  • Platelets ≥75,000 cells/mm3
  • Hemoglobin ≥8.0 g/dL
  • Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be ≤1.5 x the upper limit of the normal range (ULN)
  • Must be registered into the Revlimid REMS™program and be willing to comply with the requirements of Revlimid REMS™.

Major Exclusion Criteria:

  • Known central nervous system lymphoma
  • Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks
  • Radio- or toxin-immunoconjugates within 10 weeks
  • Prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • SITE-8

    Albuquerque, New Mexico, 87106

  • SITE-4

    Ann Arbor, Michigan, 48109

  • SITE-5

    Baltimore, Maryland, 21201

  • SITE-6

    Bethesda, Maryland, 20892

  • SITE-7

    Charleston, South Carolina, 29425

  • SITE-3

    Chicago, Illinois, 60612

  • SITE-1

    Duarte, California, 91010

  • SITE-2

    Los Angeles, California, 90095

  • SITE-10

    Orange, California, 92868

  • SITE-9

    Stony Brook, New York, 11794

Other trials in United States

About this study

Official title: A Multicenter Study of Ibrutinib and Lenalidomide in Combination With DA-EPOCH-R in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).

Read the detailed description

This is a Phase 1b, open-label, non-randomized multicenter study conducted in 2 parts. Part 1, will determine the MTD of the combination of ibrutinib, lenalidomide and DA-EPOCH-R in subjects with DLBCL.

Ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. DA-EPOCH-R will be given at standard doses.

For Part 2, the MTD determined in Part 1 will be the dose used for all subjects. If no MTD is identified, then subjects in Part 2 will be treated with the maximum administered doses (MAD, treatment doses from dose Level 4).

The primary objective for Part 2 is to determine the ORR of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with ABC DLBCL as analyzed by gene expression profiling when treated at recommended phase 2 dose (RP2D).

Being tested
Ibrutinib, DA-EPOCH-R, Lenalidomide
Keywords
DLBCL, ABC, GCB, Primary Mediastinal B-cell lymphoma, Pharmacyclics, Lenalidomide, lymphoma, Rituximab, EPOCH, Recommended Phase 2 Dose(RP2D)
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbrutinibDrug

    Ibrutinib

  • DA-EPOCH-RDrug

    Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim

  • LenalidomideDrug

    Lenalidomide

Study groups in NCT02142049
Study groupRoleWhat they receive
Part 1: Dose Level 1ExperimentalIbrutinib 560 mg PO + DA-EPOCH-R
Receives: Drug: Ibrutinib; Drug: DA-EPOCH-R
Part 1: Dose Level 2ExperimentalIbrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
Receives: Drug: Ibrutinib; Drug: DA-EPOCH-R; Drug: Lenalidomide
Part 1: Dose Level 3ExperimentalIbrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
Receives: Drug: Ibrutinib; Drug: DA-EPOCH-R; Drug: Lenalidomide
Part 1: Dose Level 4ExperimentalIbrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
Receives: Drug: Ibrutinib; Drug: DA-EPOCH-R; Drug: Lenalidomide
Part 2: RP2DExperimentalRecommended Phase 2 Dose(RP2D): Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
Receives: Drug: Ibrutinib; Drug: DA-EPOCH-R; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability

    Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R

    Measured: 1 year after last subjects received the first dose

  2. Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR

    Part 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator.

    Measured: 1 year after last subjects received the first dose

Secondary outcomes (4)

  1. Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy

    Part-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator.

    Measured: 1 year after last subjects received the first dose

  2. Number of Subjects With Adverse Events as a Measure of Safety and Tolerability

    Part 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported.

    Measured: 1 year after last subjects received the first dose

  3. Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy

    Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause. OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology.

    Measured: From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.

  4. Duration of Response (DOR)

    Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented.

    Measured: From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionAug 2017
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02142049
Sponsor's protocol ID
PCYC-1124-CA
Status last verified
May 2018
First submitted
12 May 2014
Last updated
5 Feb 2019
Data monitoring committee
No

Publications

  • Wilson WH, Phillips T, Popplewell L, de Vos S, Chhabra S, Kimball AS, Beaupre D, Huang DW, Wright G, Kwei K, Ping J, Neuenburg JK, Staudt LM. Phase 1b/2 study of ibrutinib and lenalidomide with dose-adjusted EPOCH-R in patients with relapsed/refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2021 Sep;62(9):2094-2106. doi: 10.1080/10428194.2021.1907371. Epub 2021 Apr 15.

    PubMed 33856277

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ibrutinib, DA-EPOCH-R and Lenalidomide in people with Diffuse Large B Cell Lymphoma Relapsed and Diffuse Large B Cell Lymphoma Refractory, run by Pharmacyclics LLC. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability (time frame: 1 year after last subjects received the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02142049, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.

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