Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas

  • STATUS
    Recruiting
  • End date
    Jul 31, 2025
  • participants needed
    36
  • sponsor
    Washington University School of Medicine
Updated on 25 April 2022
platelet count
stem cell transplantation
hodgkin's disease
cytarabine
melphalan
cell transplantation
gilbert's syndrome
etoposide
neutrophil count
autograft
carmustine
b-cell lymphoma
peripheral t-cell lymphoma
anaplastic large cell lymphoma
large cell lymphoma

Summary

The investigators hypothesize that duvelisib maintenance after autologous stem cell transplant in patients with T-cell lymphomas will be safe and well tolerated, and will improve progression free survival.

Details
Condition T-Cell Lymphoma
Treatment Peripheral blood draw, duvelisib
Clinical Study IdentifierNCT04331119
SponsorWashington University School of Medicine
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of T cell non-Hodgkin 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 autologous transplant within the last 30 days
At least 18 years of age at time of enrollment
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Adequate organ function as defined below
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 109/L
Platelet count ≥ 75 x 109/L
AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Women of childbearing potential and men must agree to use highly effective
Participants or a participant's legally authorized representative must be able to understand and willing to sign an IRB approved written informed consent document
contraception prior to study entry and for the duration of study participation
and for 3 months after the last dose of duvelisib. Negative serum β human
chorionic gonadotropin (βHCG) pregnancy test within 7 days before first
treatment is required if the patient is a woman of childbearing potential

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 is 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 HBV, HCV. Subjects with a positive HBsAg or HCV Ab on pre-transplant
infection screening will be excluded. Subjects with a positive HBcAb must have
negative HBV DNA to be eligible and must be periodically monitored for HBV
Pregnant or breastfeeding
reactivation by institutional guidelines
Baseline 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
Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or
they have a history of AIDS-defining opportunistic infection within the 12 months
prior to registration. Concurrent treatment with effective ART according to 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)
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