Brief Title
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
Official Title
An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor Given in Combination With a Histone Deacetylase (HDAC) Inhibitor, Romidepsin in Adult Patients With Relapsed/Refractory T-cell Lymphoma
Brief Summary
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of
Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in Patients with T cell lymphoma
Secondary Outcome
Overall response rate (ORR) with Tenalisib and Romidepsin combination
Condition
T Cell Lymphoma
Intervention
Tenalisib
Study Arms / Comparison Groups
Tenalisib+Romidepsin
Description: Participants receive Tenalisib in escalating doses daily Orally BID and Romidepsin in escalating doses intravenously on day 1, 8 and 15
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
March 12, 2019
Completion Date
May 14, 2021
Primary Completion Date
May 14, 2021
Eligibility Criteria
Inclusion Criteria:
1. Pathologically confirmed T-cell lymphomas at the enrolling institution.
2. Disease status as defined as relapsed or progressed patients who have received at
least one systemic therapy.
3. The patients should have received NOT more than three prior systemic combination
chemotherapies
4. PTCL patients must have measurable disease defined as at least one bidimensional
measurable lesion with minimum measurement of > 1.5 cm in the longest diameter.
5. Must have ECOG performance status ≤ 2
6. Adequate bone marrow, liver and renal function in line with below mentioned laboratory
requirements.
1. Hemoglobin ≥8.0 g/dL
2. Absolute neutrophil count (ANC) ≥1,000/µL
3. Platelet count ≥75,000/μL
4. Total bilirubin ≤1.5 times the ULN (or ≤3 x ULN, if patient has Gilbert syndrome)
5. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; ≤ 5 ULN in case of liver involvement
6. Calculated creatinine clearance (CrCl) > 50 ml/min by Cockcroft-Gault formula
7. Use of an effective means of contraception for women of childbearing potential and men
with partners of childbearing potential.
8. Provide written informed consent prior to any study-specific screening procedures.
9. Willingness and capability to comply with the requirements of the study
Exclusion Criteria:
1. Patient receiving anticancer therapy including any investigational therapy ≤3 weeks or
5 half-lives (whichever is shorter) prior to C1D1.
2. Patient who discontinued prior therapy with PI3K inhibitors or HDAC inhibitors due to
drug toxicity.
3. PTCL patients with Allo-SCT on active GVHD or immunosuppression therapy within 3
months prior to C1D1. CTCL patients with the history of Allo-SCT will be excluded.
4. Patient with medical conditions requiring the use of systemic immunosuppressive
medications (> 20 mg/day of prednisone or equivalent).
5. Severe bacterial, viral or mycotic infection requiring systemic treatment.
6. Known seropositive requiring anti-viral therapy for human immunodeficiency virus (HIV)
infection.
7. Known seropositive requiring anti-viral therapy for hepatitis B virus (HBV) infection
OR evidence of active hepatitis B infection as defined by detectable viral load if the
antibody tests are positive..
8. Known seropositive requiring anti-viral therapy for hepatitis c virus (HCV) infection
OR patients with positive hepatitis C virus Ab.
9. Subjects with active EBV unrelated to underlying lymphoma (positive serology for anti-
EBV VCA IgM antibody and negative for anti-EBV EBNA IgG antibody, or clinical
manifestations and positive EBV PCR consistent with active EBV infection.
10. Subject with active CMV (positive serology for anti-CMV IgM antibody and negative for
anti-CMV IgG antibody and positive CMV PCR with clinical manifestations consistent
with active CMV infection) and requiring therapy.
11. Uncontrolled or significant cardiovascular disease including, but not limited to:
- Congenital long QT syndrome.
- QTcF interval > 450 msec
- Myocardial infarction or stroke/TIA within the past 6 months
- Uncontrolled angina within the past 3 months
- Significant ECG abnormalities including 2nd degree atrio- ventricular (AV) block
(AV) block type II, 3rd degree AV block.
- History of clinically significant arrhythmias (such as ventricular tachycardia,
ventricular fibrillation or torsades de pointes),
- History of other clinically significant heart disease (ie, cardiomyopathy,
congestive heart failure with NYHA functional classification III-IV,
pericarditis, significant pericardial effusion)
- Requirement for daily supplemental oxygen therapy.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03770000
Organization ID
RP6530+Romidepsin-1805
Responsible Party
Sponsor
Study Sponsor
Rhizen Pharmaceuticals SA
Study Sponsor
, ,
Verification Date
September 2021