AzTrials
AzTrials

Follicular LymphomaPhase 2NCT03178201

TGR1202 in Relapsed and Refractory Follicular Lymphoma

A Phase 2 study testing TGR-1202 in people with Follicular Lymphoma, run by Columbia University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The primary objective is to determine the overall response rate (ORR) of TGR-1202 in R/R FL. Secondary Objectives Determine the genetic and other novel biological markers that may be predictive of response or resistance to TGR-1202 in patients with relapsed or refractory FL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
TGR-1202
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
20 Aug 2017to 30 Jun 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Histologically proven diagnosis of grade 1, 2, or 3A FL.
  • Relapse following first line immunotherapy or chemoimmunotherapy. There is no upper limit to the number of therapies received prior to study entry. Prior therapies may include high-dose therapy with autologous stem cell rescue.
  • Measurable Disease according to the Lugano classification.
  • Lymphoma that is amenable to safe pre-treatment and post-treatment biopsy. The safety of the procedures will be determined by the treating physician and the surgeon in consultation with the PI, and in accordance with standard clinical practice. Acceptable sites of disease include, for example: (1) palpable tumor mass that is accessible under direct visualization or sonogram, (2) non-palpable tumor tissue that is accessible for biopsy under computed tomography (CT) or sonogram guidance, (3) bone marrow.
  • Age >18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <2
Show all 15Show fewer
  • Patients must have adequate organ and marrow function as defined below:
  • absolute neutrophil count >1,000/microliter
  • platelet count ≥50,000/microliter
  • bilirubin <1.5 x institutional upper limit of normal
  • aspartate transaminase (AST, SGOT)/alanine transaminase (ALT, SGPT) <3.0 x institutional upper limit of normal
  • Serum creatinine <2.0 x institutional upper limit of normal or creatinine clearance >50 mL/min (according to the Cockcroft and Gault equation).
  • Negative serum pregnancy test within 7 days prior to Cycle 1/Day 1 for women of childbearing potential.
  • All women of childbearing potential must agree to use an effective barrier method of contraception, as described in Appendix 4, during the treatment period and for at least 1 month after discontinuation of the study drug. Male subjects should use effective barrier method of contraception during the treatment period and for at least 1 month after discontinuation of the study drug
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Grade 3B FL or evidence of transformation to a more aggressive lymphoma
  • Prior and concomitant therapy:
  • Prior exposure to any PI3 Kinase inhibitor
  • Exposure to chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to entering the study or lack of recovery from adverse events (AE) due to previously administered treatments.
  • Ongoing chronic immunosuppressants (e.g. cyclosporine) or systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drug.
  • Other concurrent investigational agents during the study period.
Show all 26Show fewer
  • Prior allogeneic stem cell transplant
  • Central nervous system lymphoma, including lymphomatous meningitis
  • Acute intercurrent illness including, but not limited to, active infection, unstable congestive heart failure, unstable angina pectoris, psychiatric illness or any social situation that would limit compliance with study participation requirements in the judgement of the investigator.
  • Major surgery performed within 4 weeks of study entry
  • Pregnant or nursing women
  • Active concurrent malignancy (except non-invasive non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3-years at the time of study entry.
  • Documented Human Immunodeficiency Virus (HIV)-infection
  • Active hepatitis A, hepatitis B, or hepatitis C infection
  • History of tuberculosis treatment within 2 years of study entry
  • Administration of a live vaccine within 6 weeks of first dose of study drug
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
  • Lymphoma that is not amenable for mandatory pre- and post-treatment biopsy as described in the inclusion criteria.
  • Unstable or severe uncontrolled medical condition (e.g. unstable cardiac function, unstable pulmonary condition, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his or her participation in the study
  • Clinically significant cardiovascular abnormalities such as:
  • QTc ≥ 470 msec.
  • Angina not well-controlled by medication
  • Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 6 months of enrollment
  • Symptomatic or documented congestive heart failure that meets New York Heart Association (NYHA) Class III to IV definitions;
  • History of stroke within the last 6 months prior to screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10019

Other trials in United States

About this study

Official title: Study of the Phosphoinositide-3-Kinase-Delta Inhibitor TGR-1202 in Patients With Relapsed or Refractory Follicular Lymphoma

The primary objective is to determine the overall response rate (ORR) of TGR-1202 in R/R FL.

Secondary Objectives

  • Determine the genetic and other novel biological markers that may be predictive of response or resistance to TGR-1202 in patients with relapsed or refractory FL.
  • Describe the Progression Free Survival (PFS), Duration of Response (DoR) after treatment with TGR-1202.
  • Describe the number of dose delays and dose reductions and other safety profile.
Read the detailed description

This is an open label, phase II study of TGR-1202 in patients with relapsed or refractory (R/R) Grade 1, 2, or 3A follicular lymphoma (FL). FL is the most common subtype of indolent lymphoma. The prognosis of FL depends on the histologic grade, stage, treatment and age of the patient. More recently, efforts have been made to find novel regimens for the treatment of relapsed FL that do not contain non-specific cytotoxic agents.

One of the important goals of this phase II study is to discover novel genetic, biochemical, and immunological markers that are associated with the response and safety of TGR-1202 in patients with FL. TGR-1202 blocks PI3K, a signal that is required for cancer to grow.

Being tested
TGR-1202
Keywords
Relapsed follicular lymphoma, Refractory follicular lymphoma
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • TGR-1202Drug

    Also called formerly as RP5307

    Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days.

Study groups in NCT03178201
Study groupRoleWhat they receive
TGR-1202ExperimentalPatients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.
Receives: Drug: TGR-1202

What is being measured

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

  1. Overall Response Rate

    The sum of patients with partial responses and complete responses.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Progression Free Survival (PFS) After Treatment With TGR-1202

    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

    Measured: Up to 3 years

  2. Duration of Response (DoR) After Treatment With TGR-1202

    The time of initial response until documented tumor progression.

    Measured: Up to 3 years

  3. Number of Dose Delays

    The number of instances of patients having a dose of study drug delayed 1 or more days.

    Measured: Up to 3 years

  4. Number of Dose Reductions

    The number of instances of patients having to reduce the dosage of study drug based on specified toxicities.

    Measured: Up to 3 years

  5. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] broken down by adverse event and CTCAE v4.0 grade of each event.

    Measured: Up to 3 years

Timeline

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

  1. First posted6 Jun 2017
  2. Study start20 Aug 2017
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Why it stopped: PI left institution

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03178201
Sponsor's protocol ID
AAAR1223
Status last verified
Jun 2021
First submitted
1 Jun 2017
Last updated
16 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TGR-1202 in people with Follicular Lymphoma, run by Columbia University at 1 site in United States.

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 15 inclusion and 26 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: stopped early, as of the sponsor's last update on 16 Jul 2021. 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 United States. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 16 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate (time frame: Up to 3 years). 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 NCT03178201.

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 16 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in