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Duvelisib Maintenance after Autologous Stem Cell Transplant for the Treatment of T-Cell or Indolent B-Cell Lymphoma

Trial Status: Active

This phase II trial studies how well duvelisib works as maintenance therapy after autologous stem cell transplant works in treating patients with T-cell or indolent B-cell lymphomas. Maintenance therapy refers to treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Treatment with duvelisib may help keep lymphoma in remission after transplant.

Inclusion Criteria

  • Diagnosis of T cell non-Hodgkin lymphoma, or indolent B cell non-Hodgkin lymphoma. B-cell histologies include follicular, chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic, or marginal zone lymphomas, and include transformed to aggressive B-cell lymphoma. T cell lymphomas included are peripheral T cell lymphoma not otherwise specified, angioimmunoblastic T cell lymphoma, and systemic anaplastic large cell lymphoma
  • Eligible for autologous stem cell transplantation as determined by the treating physician or completed BEAM autologous transplant within the last 30 days
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Serum creatinine =< 1.5 times institutional upper limit of normal (IULN)
  • Total bilirubin =< 1.5 x IULN. Patients with Gilbert’s syndrome may have a bilirubin > 1.5 x IULN
  • Hemoglobin >= 8.0 g/dL
  • Absolute neutrophil count >= 1.0 x 10^9/L
  • Platelet count >= 75 x 10^9/L
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x IULN
  • Women of childbearing potential and men must agree to use highly effective contraception prior to study entry and for the duration of study participation and for 3 months after the last dose of duvelisib. Negative serum beta human chorionic gonadotropin (betaHCG) pregnancy test within 7 days before first treatment is required if the patient is a woman of childbearing potential
  • Participants or a participant’s legally authorized representative must be able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

Exclusion Criteria

  • Currently receiving any other experimental therapy or has received experimental therapy within 4 weeks prior to study treatment
  • History of allergic reaction attributed to compounds of similar chemical or biologic composition to duvelisib or other agents used in the study
  • Prior history of drug-induced colitis or drug-induced pneumonitis
  • History of concurrent interstitial lung disease or severely impaired lung function
  • History of chronic liver disease or veno-occlusive disease
  • History of tuberculosis within 2 years prior to enrollment
  • Administration of a live or live attenuated vaccine within 6 weeks of first duvelisib dose
  • Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) per day
  • Ongoing treatment for systemic bacterial, fungal, or viral infections at screening. * Note: Patients on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Infection with hepatitis B virus (HBV), hepatitis C virus (HCV). Subjects with a positive hepatitis B surface antigen (HBsAg) or HCV antibody (Ab) on pre-transplant infection screening will be excluded. Subjects with a positive hepatitis B core antibody (HBcAb) must have negative HBV deoxyribonucleic acid (DNA) to be eligible and must be periodically monitored for HBV reactivation by institutional guidelines
  • Baseline corrected QT interval by Fridericia's formula (QTcF) > 500 milliseconds. This does not apply to subjects with right or left bundle branch blocks
  • Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment
  • Clinically significant medical condition of malabsorption, inflammatory bowel disease, chronic conditions which manifest with diarrhea, refractory nausea, vomiting, or any other condition that will interfere significantly with drug absorption
  • Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention
  • Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection (i.e., subjects with detectable viral load)
  • History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or a pacemaker within the last 6 months prior to screening
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or unstable cardiac arrhythmia
  • Pregnant or breastfeeding
  • Patients with human immunodeficiency virus (HIV) are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. concurrent strong CYP3A4 inhibitors [ritonavir and cobicistat] or inducers [efavirenz] are contraindicated)

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
Contact: Amanda Fishback Cashen
Phone: 314-454-8323

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of one year of duvelisib maintenance after carmustine, etoposide, cytarabine, and melphalan (BEAM) autologous stem cell transplantation (ASCT) in patients with T cell lymphoma or indolent lymphoma.

SECONDARY OBJECTIVES:

I. To evaluate the safety of duvelisib maintenance after BEAM ASCT.

II. To determine other measures of efficacy.

OUTLINE:

Starting on day 30 post standard of care BEAM ASCT, patients receive duvelisib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with complete remission then receive duvelisib PO BID on days 1-14. Treatment repeats every 28 days for up to 11 cycles (one year post-transplant) in the absence of disease progression or unacceptable toxicity. Patients with partial remission after the first 2 cycles continue to receive duvelisib PO BID on days 1-28 of each 28-day cycle, and undergo assessment every 3 cycles. Once these patients show complete remission, they receive duvelisib PO BID on days 1-14. Treatment repeats every 28 days for 11 cycles (one year post-transplant) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, and every 3 months for 1 year.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Siteman Cancer Center at Washington University

Principal Investigator
Amanda Fishback Cashen

  • Primary ID 202005165
  • Secondary IDs NCI-2020-05151
  • Clinicaltrials.gov ID NCT04331119