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LymphomaPhase 2NCT02605694

Duvelisib With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO)

A Phase 2 study testing Duvelisib, Rituximab and R-CHOP in people with Lymphoma, run by SecuraBio at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phase II study to evaluate the efficacy and safety of DR vs R-CHOP in subjects with relapsed/refractory FL Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Duvelisib, Rituximab and R-CHOP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2015to Nov 2016
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Diagnosis of FL: Grade 1, 2, or 3a
  • Progressed within 24 months of initiating an alkylator-based chemotherapy regimen given as either first- or second-line therapy; single-agent chlorambucil therapy does not fulfill this requirement Note: subjects must have received at least 2 cycles of alkylator-based chemotherapy to be eligible
  • Previously received rituximab, either as single agent or as part of any combination regimen, and also meet one of the following requirements:
  • Progressed within 24 months of initiating alkylator-based chemotherapy in the first line and received no additional anticancer therapy
  • Progressed within 24 months of initiating alkylator-based chemotherapy in the first line and subsequently progressed within 24 months of receiving any second-line treatment and received no additional anticancer therapy
  • Progressed within 24 months of initiating alkylator-based chemotherapy in the second line and received no additional anticancer therapy
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  • Appropriate to receive R-CHOP
  • At least 1 measurable disease lesion > 1.5 cm in at least one dimension by computed tomography (CT), CT-PET, or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (corresponds to Karnofsky Performance Status [(KPS) ≥60%])
  • For women of childbearing potential (WCBP): negative serum β human chorionic gonadotropin (βhCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 12 consecutive months for women >55 years of age)

Who cannot join

  • Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
  • Received ≥ 3 previous anticancer regimens prior to enrollment
  • Received prior R-CHOP therapy
  • Previous receipt of any anthracycline
  • Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone) Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine protein, or known hypersensitivity to any of the study drugs
  • Received prior allogeneic transplant
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  • Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
  • History of tuberculosis treatment within the two years prior to randomization
  • History of chronic liver disease, veno-occlusive disease, alcohol abuse
  • Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids >20 mg of prednisone (or equivalent) QD
  • Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
  • Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A)
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Miami, Florida, 33133

Other trials in United States

About this study

Official title: A Phase 2, Randomized Study of Duvelisib Administered in Combination With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO)

Phase II study to evaluate the efficacy and safety of DR vs R-CHOP in subjects with relapsed/refractory FL

Read the detailed description

This is a phase 2, randomized, two-arm, open-label study designed to evaluate the efficacy and safety of Duvelisib Administered in Combination with Rituximab vs R-CHOP in Subjects with Relapsed/Refractory Follicular Lymphoma.

Conditions
Lymphoma
Being tested
Duvelisib, Rituximab, R-CHOP, Prednisone
Medical subject headings
Lymphoma

What participants receive

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

  • DuvelisibDrug

    Also called IPI-145

    25 mg will be administered orally twice daily (BID) during 21-day cycles (Cycles 1-6) followed by 28-day cycles (Cycle 7 and beyond) until disease progression or unacceptable toxicity

  • RituximabDrug

    Also called MabThera, Rituxan

    375 mg/m2 will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).

  • R-CHOPDrug

    Also called Rituximab, CHOP

    IV infusion on Day 1 of Cycles 1-6 (21-day cycles)

    • Cyclophosphamide (750 mg/m2)
    • Doxorubicin hydrochloride (50 mg/m2)
    • Vincristine sulfate (1.4 mg/m2) (2 mg maximum)
    • Rituximab (375 mg/m2)

  • PrednisoneDrug

    Also called Deltasone

    100 mg orally on Days 1-5 of Cycles 1-6 (21-day cycles)

Study groups in NCT02605694
Study groupRoleWhat they receive
Arm 1ExperimentalDuvelisib 25 mg will be administered orally twice daily (BID) during 21-day cycles (Cycles 1-6) followed by 28-day cycles (Cycle 7 and beyond) until disease progression or unacceptable toxicity; and Rituximab (375 mg/m2) will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).
Receives: Drug: Duvelisib; Drug: Rituximab
Arm 2Active comparatorR-CHOP will be administered as follows: IV infusion on Day 1 of Cycles 1-6 (21-day cycles) * Cyclophosphamide (750 mg/m2) * Doxorubicin hydrochloride (50 mg/m2) * Vincristine sulfate (1.4 mg/m2) (2 mg maximum) * Rituximab (375 mg/m2) Orally on Days 1-5 of Cycles 1-6 (21-day cycles) * Prednisone (100 mg) will be administered.
Receives: Drug: Rituximab; Drug: R-CHOP; Drug: Prednisone

What is being measured

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

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS), defined according to the revised International Working Group (IWG) criteria as assessed by the Independent Review Committee (IRC)

    Measured: Time from randomization to documented disease progression, or death due to any cause, whatever comes first, assessed up to approximately 44 months.

Secondary outcomes (7)

  1. Complete Response Rate (CRR)

    Complete Response Rate (CRR) with complete response defined according to the revised IWG criteria as assessed by the IRC

    Measured: Every 3-6 Cycles (Cycles 1-6 are 21-days; after Cycle 7 are 28-days) from randomization until first documented progression. Subjects will be evaluated for progression or the primary analysis of PFS, whichever occurs first.

  2. Overall Response Rate (ORR)

    ORR defined as best response of complete response (CR) or partial response/remission (PR), according to the revised IWG criteria as assessed by the IRC

    Measured: Every 3-6 Cycles (Cycles 1-6 are 21-days; after Cycle 7 are 28-days) from randomization until first documented progression or the primary analysis of PFS, whichever occurs first.

  3. Overall Survival

    Measured: Every 6 months until the primary analysis for PFS or 3 years from randomization, whichever occurs later.

  4. Safety (Treatment Emergent Adverse Events (TEAEs) and changes in safety laboratory values as assessed by NCI-CTCAE, version 4.03)

    Adverse events (AEs) and abnormal laboratory values

    Measured: Continuous from informed consent until 30 days from last dose

  5. Pharmacokinetics: Evaluate the Duvelisib concentration in plasma sample

    Evaluate the Duvelisib concentration in plasma sample

    Measured: Cycle 1 Day 15, Cycle 2 Day 1 and 15 (Cycles 1-6 are 21-day cycles)

  6. Duration of Response

    DOR defined as the time from the first documented response to the first documentation of progressive disease (PD) according to the revised IWG criteria or death due to any cause (for subjects with CR or PR only)

    Measured: Every 3-6 Cycles (Cycles 1-6 are 21-days; after Cycle 7 are 28-days) from the first documented response to first documented progression or death, whichever occurs first.

  7. Pharmacokinetics: Evaluate IPI-656 (metabolite) concentration in plasma sample

    Evaluate IPI-656 (metabolite) concentration in plasma sample

    Measured: Cycle 1 Day 15, Cycle 2 Day 1 and 15 (Cycles 1-6 are 21-day cycles)

Timeline

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

  1. First posted16 Nov 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Why it stopped: Sponsor is focusing on studies which can enable registration of duvelisib

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605694
Sponsor's protocol ID
IPI-145-21
Other IDs
2015-004729-15, 2015
Status last verified
Mar 2021
First submitted
4 Nov 2015
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Duvelisib, Rituximab and R-CHOP in people with Lymphoma, run by SecuraBio at 1 site 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?

The sponsor lists 10 inclusion and 15 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Progression Free Survival (PFS) (time frame: Time from randomization to documented disease progression, or death due to any cause, whatever comes first, assessed up to approximately 44 months.). 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 NCT02605694.

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 17 Mar 2021.

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