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Mature T-Cell and NK-Cell NeoplasmPhase 1/2NCT03052933

Copanlisib and Gemcitabine in Relapsed/Refractory PTCL

A Phase 1/2 study testing Copanlisib and Gemcitabine in people with Mature T-Cell and NK-Cell Neoplasm, run by Chonnam National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol, which would be expected to be feasible and effective in this group of patients. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Mature T-Cell and NK-Cell Neoplasm
What is being tested?
Copanlisib and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
1 Feb 2018to 1 Jul 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed relapsed or refractory PTCL or NK/T-cell lymphomas, excluding primary cutaneous T-cell lymphoma, and Sezary syndrome based on WHO classification,
  • Age ≥ 19
  • ECOG performance status ≤ 2
  • at least one bi-dimensional measurable lesion
  • Laboratory values
  • Serum Cr < 1.5 mg/dL or CrCl > 50 mL/min
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  • Transaminase (AST/ALT) < 2.5 x ULN (or < 5 x ULN in the presence of lymphoma involvement of the liver)
  • Bilirubin < 1.5 x UNL ( or < 3 x ULN in the presence of lymphoma involvement of the liver or Gilbert syndrome)
  • PT (INR) ≤ 1.5 x ULN and aPTT ≤ 1.5 x ULN
  • Lipase ≤ 1.5 x ULN
  • Hematologic functions: absolute neutrophil count (ANC) ≥ 1,500/µL and platelet count ≥ 75,000/µL, hemoglobin ≥ 8 g/dL
  • Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal for the institution
  • Women of childbearing potential and men must agree to use adequate contraception when sexually active
  • Written informed consent

Who cannot join

  • B-cell NHL, or primary cutaneous T-cell lymphoma and Sezary syndrome
  • Patients who had previous history of lymphoma involvement of the CNS.
  • History of previous gemcitabine therapy
  • Type I or II diabetes mellitus with HbA1c > 8.5% at screening
  • History of chronic hepatitis B; subjects positive for HBsAg will be excluded from this study. However, subjects with HBcAb will be eligible if they are negative for HBV DNA quantification
  • History of chronic hepatitis C; subjects positive for HCV IgG will be eligible if they are negative for HCV-RNA quantification
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  • Known history of human immunodeficiency virus (HIV) infection
  • History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
  • Any other malignancies within the past 3 years except curatively treated basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or papillary carcinoma of the thyroid
  • Other serious illness or medical conditions
  • Congestive heart failure > NYHA class 2 (Appendix III)
  • Unstable angina or new-onset angina within the last 3 months; Myocardial infarction within 6 months prior to study entry
  • History of significant neurological or psychiatric disorders including dementia or seizure
  • Uncontrolled hypertension despite optimal medical management (per investigator's opinion)
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of study treatment
  • Non-healing wound, ulcer, or bone fracture
  • Active uncontrolled infection (viral, bacterial, or fungal infection)
  • Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks of start of study medication
  • Proteinuria estimated by urine protein/creatinine ratio > 3.5 on a random urine sample
  • Concurrent diagnosis of pheochromocytoma
  • Other previous or concurrent treatments
  • Ongoing immunosuppressive therapy
  • Radiotherapy or immune-/chemotherapy less than 4 weeks before start of treatment
  • Radioimmunotherapy or autologous transplant less than 3 months before start of treatment
  • Myeloid growth factors within 14 days prior to treatment start
  • Blood or platelet transfusion within 7 days prior to treatment start
  • Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent
  • History of having received an allogeneic bone marrow or organ transplant
  • Major surgical procedure or significant trauma injury within 28 days before start of study medication, open biopsy within 7 days before start of study treatment
  • Anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
  • Use of CYP3A4 inhibitor or inducer
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Concomitant administration of any other experimental drugs under investigation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 519-809

Other trials in South Korea

About this study

Official title: Prospective, Multicenter, Open-labeled, Phase I/II Study of the Efficacy and Safety of Copanlisib (BAY 80-6946) and Gemcitabine Combination in Patients With Relapsed/Refractory Peripheral T-cell or NK/T-cell Lymphoma

COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol, which would be expected to be feasible and effective in this group of patients.

Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in relapsed/refractory, aggressive NHLs, suggesting an ORR of 50% for T-cell lymphomas.

Read more

Gemcitabine has demonstrated clinical antitumor activity against PTCLs including NK/T-cell lymphomas both as single-agent (ORR 30-50%) and in combination therapy, with limited extramedullary toxicities.

Considering the evidence of activity for both agents against PTCLs, the investigators propose that targeted therapy with copanlisib in combination with gemcitabine will exhibit early elimination of rapidly growing tumor cells and be a rational therapeutic modality for use in relapsed or refractory PTCLs, if the overlapping toxicities can be managed.

Being tested
Copanlisib, Gemcitabine
Keywords
copanlisib, gemcitabine, peripheral T-cell lymphoma, extranodal NK/T-cell lymphoma
Medical subject headings
Lymphoma, T-Cell, Peripheral, Lymphoma, Extranodal NK-T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CopanlisibDrug

    For phase I study, participants will receive copanlisib (in combination with gemcitabine) IV infusion at a dose of 45 mg or 60 mg on Days 1, 8, and 15 of each 28-day treatment cycle. During phase I study, participants will be treated at the level of 45 mg/dose (level+0), or 60 mg/dose (level+1) of copanlisib. Maximal tolerated dose will be determined by modified 3+3 design including level-1 dose de-escalation.

    For phase II study, copanlisib dose level, determined during phase I study, will be administered on Days 1, 8, and 15.

    Maximum 6 cycles of gemcitabine and copanlisib combination and subsequent copanlisib monotherapy in participants with ≥ SD to copanlisib and gemcitabine until maximum 12 cycles will be given for this study.

  • GemcitabineDrug

    For phase I/II study, participants will receive gemcitabine (in combination with copanlisib) IV infusion at fixed dose of 1,000 mg/m2 on Days 1 and 8 of each 28-day treatment cycle until maximum 6 cycles.

Study groups in NCT03052933
Study groupRoleWhat they receive
Copanlisib/gemcitabineExperimentalNot described
Receives: Drug: Copanlisib; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity (DLT), Maximum tolerated dose (MTD) for phase I

    The recommended dose of the combination of copanlisib and gemcitabine in patients with mature T-cell or NK/T cell neoplasm

    Measured: 4 weeks

  2. Objective response rate for phase II

    Primary efficacy data will be maximal change of radiological tumor lesion measurement using CT scan at baseline and every two cycles, with the evaluation of overall response rate, defined as the percentage of patients with a complete response (CR) or a partial response (PR).

    Measured: 1 year

Secondary outcomes (3)

  1. adverse events

    Toxicity will be graded according to the NCI-CTCAC version 4.0, from the first day of the first cycle of COPGEM chemotherapy to 30 days after the last dose of study drug.

    Measured: 2 year

  2. Progression-free survival (PFS)

    PFS will be calculated from the start of study drug treatment to the date of disease progression, death, or last follow-up, as appropriate.

    Measured: 2 year

  3. Overall survival (OS)

    OS will be calculated from the start of study drug treatment to the date of disease death or last follow-up, as appropriate.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start1 Feb 2018
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03052933
Sponsor's protocol ID
COPGEM
Status last verified
Jun 2022
First submitted
10 Feb 2017
Last updated
10 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Copanlisib and Gemcitabine in people with Mature T-Cell and NK-Cell Neoplasm, run by Chonnam National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT), Maximum tolerated dose (MTD) for phase I (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03052933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.

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