We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02605694
Recruitment Status : Withdrawn (Sponsor is focusing on studies which can enable registration of duvelisib)
First Posted : November 16, 2015
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
SecuraBio

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

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Duvelisib Drug: Rituximab Drug: R-CHOP Drug: Prednisone Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Arm 1
Duvelisib 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).
Drug: Duvelisib
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
Other Name: IPI-145

Drug: Rituximab
375 mg/m2 will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).
Other Names:
  • MabThera
  • Rituxan

Active Comparator: Arm 2

R-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.
Drug: Rituximab
375 mg/m2 will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).
Other Names:
  • MabThera
  • Rituxan

Drug: R-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)
Other Names:
  • Rituximab
  • CHOP

Drug: Prednisone
100 mg orally on Days 1-5 of Cycles 1-6 (21-day cycles)
Other Name: Deltasone




Primary Outcome Measures :
  1. 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. ]
    Progression Free Survival (PFS), defined according to the revised International Working Group (IWG) criteria as assessed by the Independent Review Committee (IRC)


Secondary Outcome Measures :
  1. Complete Response Rate (CRR) [ Time Frame: 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. ]
    Complete Response Rate (CRR) with complete response defined according to the revised IWG criteria as assessed by the IRC

  2. Overall Response Rate (ORR) [ Time Frame: 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. ]
    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

  3. Overall Survival [ Time Frame: 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) [ Time Frame: Continuous from informed consent until 30 days from last dose ]
    Adverse events (AEs) and abnormal laboratory values

  5. Pharmacokinetics: Evaluate the Duvelisib concentration in plasma sample [ Time Frame: Cycle 1 Day 15, Cycle 2 Day 1 and 15 (Cycles 1-6 are 21-day cycles) ]
    Evaluate the Duvelisib concentration in plasma sample

  6. Duration of Response [ Time Frame: 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. ]
    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)

  7. Pharmacokinetics: Evaluate IPI-656 (metabolite) concentration in plasma sample [ Time Frame: Cycle 1 Day 15, Cycle 2 Day 1 and 15 (Cycles 1-6 are 21-day cycles) ]
    Evaluate IPI-656 (metabolite) concentration in plasma sample



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of FL: Grade 1, 2, or 3a
  2. 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
  3. Previously received rituximab, either as single agent or as part of any combination regimen, and also meet one of the following requirements:

    1. Progressed within 24 months of initiating alkylator-based chemotherapy in the first line and received no additional anticancer therapy
    2. 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
    3. Progressed within 24 months of initiating alkylator-based chemotherapy in the second line and received no additional anticancer therapy
  4. Appropriate to receive R-CHOP
  5. 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)
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (corresponds to Karnofsky Performance Status [(KPS) ≥60%])
  7. 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)

Exclusion Criteria:

  1. Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3B FL
  2. Received ≥ 3 previous anticancer regimens prior to enrollment
  3. Received prior R-CHOP therapy
  4. Previous receipt of any anthracycline
  5. 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
  6. Received prior allogeneic transplant
  7. Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
  8. History of tuberculosis treatment within the two years prior to randomization
  9. History of chronic liver disease, veno-occlusive disease, alcohol abuse
  10. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids >20 mg of prednisone (or equivalent) QD
  11. Ongoing treatment for systemic bacterial, fungal, or viral infection at screening
  12. Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A)
  13. Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  14. Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix
  15. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening

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): NCT02605694


Locations
Layout table for location information
United States, Florida
Miami, Florida, United States, 33133
Sponsors and Collaborators
SecuraBio
Investigators
Layout table for investigator information
Study Chair: Hagop Youssoufian, MD Verastem, Inc.
Layout table for additonal information
Responsible Party: SecuraBio
ClinicalTrials.gov Identifier: NCT02605694    
Other Study ID Numbers: IPI-145-21
2015-004729-15 ( EudraCT Number )
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal