Description:
This study will examine the effects of predefined 2 week duvelisib dose holidays on tumor
responses and safety/tolerability.
Title
- Brief Title: A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO)
- Official Title: A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non Hodgkin Lymphoma (iNHL) (TEMPO)
Clinical Trial IDs
- ORG STUDY ID:
VS-0145-229
- NCT ID:
NCT04038359
Conditions
- Indolent Non-hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Duvelisib | Copiktra, VS-0145 | Duvelisib, Continuous and Intermittent Dosing |
Purpose
This study will examine the effects of predefined 2 week duvelisib dose holidays on tumor
responses and safety/tolerability.
Detailed Description
This is a Phase 2, randomized, open-label, 2 arm study designed to evaluate the efficacy and
safety of prescribed drug holidays of duvelisib treatment in subjects with R/R iNHL who have
received at least 1 prior systemic therapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Duvelisib, Continuous and Intermittent Dosing | Experimental | Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed two weeks on and two weeks off of each subsequent 4-week cycles. | |
Duvelisib, Intermittent Dosing | Experimental | Duvelisib 25 mg BID dosed two weeks on and two weeks off. | |
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years, ECOG performance status ≤ 2
- Histologically confirmed diagnosis of iNHL (Subtypes include FL Grades 1 to 3a,
marginal zone lymphoma (splenic, nodal, or extranodal), or SLL
- Must have received 1 prior systemic regimen for iNHL
- Must have documented radiologic evidence of disease progression, and at least 1
bi-dimensionally measurable lesion ≥ 1.5 cm (which has not been previously
irradiated), according to 2007 revised IWG criteria
- Must have adequate organ function defined by the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
- Platelet count ≥ 75 × 10^9/L
- Serum creatinine < 2.0 mg/dL (197 µmol/L)
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: subjects with
Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
- Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and
alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) ≤ 3.0 × ULN
Exclusion Criteria:
- Anticancer treatment, major surgery, or use of any investigational drug within 28 days
before the start of study intervention; palliative radiation therapy is allowed if > 7
days and any toxicity is Grade ≤ 1
- Clinical or histological evidence of transformation to a more aggressive subtype of
lymphoma or grade 3b FL or Richters' transformation or CLL
- Prior allogeneic hematopoietic stem cell transplant (HSCT); treatment with a PI3K
inhibitor
- History of drug-induced colitis or pneumonitis; TB treatment ≤ 2 years prior to
randomization; administration of a live or live attenuated vaccine within 6 weeks of
randomization
- Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment
for systemic bacterial, fungal, or viral infection
- Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection
- Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV),
or herpes zoster (VZV) at screening
- 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.
- Baseline QTcF > 500 ms
- Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ
of the cervix, bladder cancer, or prostate cancer not requiring treatment. Subjects
with previous malignancies are eligible if they have been disease-free for 2 years or
more.
- Unstable or severe uncontrolled medical condition that would, in the Investigator's
judgment, increase the subject's risk to participating in this study.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | ORR (Objective Response Rate) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria. |
Secondary Outcome Measures
Measure: | PFS (Progression Free Survival) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | From time of first dose of study intervention to PD or death. |
Measure: | ORR (Objective Response Rate) |
Time Frame: | ORR estimated at 6, 12, 18, and 24 months after first dose of study intervention. |
Safety Issue: | |
Description: | Proportion of subjects achieving a CR or PR will be estimated as per Lugano Criteria |
Measure: | DOR (Duration of Response) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | From the time of first response to PD using KM methods. |
Measure: | OS (Overall Survival) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | From time of first dose of study intervention to death. |
Measure: | LNRR (Lymph Node Response Rate) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | LNRR will be calculated as the proportion of subjects achieving ≥ 50% decrease in the SPD of target lymph nodes. |
Measure: | TTFR (Time To First Relapse) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | From the time of first dose of study intervention to time of first CR or PR. |
Measure: | Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 |
Time Frame: | 36 months |
Safety Issue: | |
Description: | From the time of screening to the end of Safety Follow-Up period of the study. |
Measure: | Peak Plasma Concentration (Cmax) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | |
Measure: | TTF (Time To Treatment Failure) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | From first dose of study intervention until discontinuation for any reason and will be summarized using KM methods. |
Measure: | Area under the plasma concentration versus time curve (AUC) |
Time Frame: | 36 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | SecuraBio |
Trial Keywords
Last Updated
May 18, 2021