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Chronic Lymphocytic LeukemiaPhase 1NCT01699152

Phase 1 Study of TG02 Citrate in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

A Phase 1 study testing TG02 citrate in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Tragara Pharmaceuticals, Inc. at 5 sites in United States.

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

This is a multi-center, open-label, dose escalation study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TG02 citrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
5 sitesUnited States
Study dates
Sep 2012to May 2016
Phase
Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma.
  • Patients must meet one or more of the following indications for treatment:
  • Progressive disease or marked splenomegaly and/or lymphadenopathy.
  • Anemia (hemoglobin <11 mg/dL) or thrombocytopenia (platelets<100,000/μL).
  • Unexplained weight loss exceeding 10% of body weight over the previous 6 months.
  • CTCAE Grade 2 or 3 fatigue.
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  • Fevers >100.5º F or night sweats for more than 2 weeks without evidence of infection.
  • Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period or a doubling time of less than 6 months.
  • Need for cytoreduction prior to allogeneic stem cell transplant.
  • Patients must have relapsed or refractory disease after ≥1 prior line of treatment.
  • The interval from prior treatment to time of study drug administration should be at least 5 half-lives for cytotoxic and noncytotoxic agents.
  • Low-dose corticosteroids (prednisone <20 mg/ day or equivalent dose) are permitted throughout study.
  • Clinically significant toxicities from prior chemotherapy must be resolved to Grade ≤ 1.
  • Age >18 years.
  • ECOG performance status ≤2.
  • Life expectancy ≥ 12 weeks.
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count >1,000/μL in absence of bone marrow involvement
  • platelets ≥30,000/μL in absence of bone marrow involvement
  • If patient has extensive bone marrow involvement, minimum ANC and platelet levels are not required.
  • total bilirubin ≤1.5 X institutional ULN unless due to Gilbert's syndrome, controlled autoimmune hemolytic anemia or immune thrombocytopenia
  • AST(SGOT)/ALT(SGPT) <2.5 X institutional ULN unless due to disease
  • creatinine <2.0 mg/dL OR creatinine clearance >50 mL/min/1.73 m2
  • Negative serum or urine pregnancy test at the time of first dose for WOCBP.
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for required assessments.
  • Ability to take oral medication.

Who cannot join

  • Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (CTCAE Grade > 1) due to agents administered more than 3 weeks earlier.
  • Patients who have received prior treatment with a CDK inhibitor within 12 months of study enrollment.
  • High-dose corticosteroids (prednisone ≥20mg/day or equivalent dose) must be discontinued ≥ 7 days of initiating therapy.
  • Patients with known central nervous system involvement.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition as TG02 citrate.
  • Patients with G6PD deficiency.
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  • Concurrent severe or uncontrolled medical disease (including but not limited to history of ventricular arrhythmia or symptomatic conduction abnormality within 12 months, ongoing or active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
  • Pregnant and/or breast-feeding women.
  • Prior or second malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or other cancer for which the subject has received curative therapy at least 3 years prior to study entry.
  • Known HIV or AIDs.
  • QTc interval prolongation >450ms for males and >470 ms for females.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • GRU

    Augusta, Georgia, 30912

  • DFCI

    Boston, Massachusetts, 02215

  • OSU

    Columbus, Ohio, 43210

  • MDACC

    Houston, Texas, 77030

  • SCRI

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Phase 1 Dose-Escalation and Pharmacokinetic Study of TG02 Citrate in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

This is a multi-center, open-label, dose escalation study.

Read the detailed description

The primary objective is to determine the highest dose of TG02 citrate that can be safely given to patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma.

Being tested
TG02 citrate
Keywords
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • TG02 citrateDrug

    Also called No other names

    TG02 citrate capsules

Study groups in NCT01699152
Study groupRoleWhat they receive
TG02 citrateExperimentalTG02 citrate capsules given orally.
Receives: Drug: TG02 citrate

What is being measured

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

  1. Maximum Tolerated Dose

    To assess the number of patients with dose-limiting toxicities (DLT) and the dose of TG02 citrate that can be safely given to patients with CLL or SLL.

    Measured: 28 days

Secondary outcomes (1)

  1. Adverse Events

    The number of patients with adverse events

    Measured: 28 days

Timeline

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

  1. First posted3 Oct 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2015
  4. Study completionMay 2016

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01699152
Sponsor's protocol ID
TG02-102
Status last verified
May 2016
First submitted
1 Oct 2012
Last updated
25 Jul 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TG02 citrate in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Tragara Pharmaceuticals, Inc. at 5 sites 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 26 inclusion and 11 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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 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.

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?

Maximum Tolerated Dose (time frame: 28 days). 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 NCT01699152.

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 25 Jul 2019.

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