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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

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Trial Information

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


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.


Inclusion Criteria:



- Patients must have histologically confirmed Chronic Lymphocytic Leukemia Small
Lymphocytic Lymphoma.

- Patients must meet one or more of the following indications for treatment:

1. Progressive disease or marked splenomegaly and/or lymphadenopathy.

2. Anemia (hemoglobin <11 mg/dL) or thrombocytopenia (platelets<100,000/μL).

3. Unexplained weight loss exceeding 10% of body weight over the previous 6 months.

4. CTCAE Grade 2 or 3 fatigue.

5. Fevers >100.5º F or night sweats for more than 2 weeks without evidence of
infection.

6. Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period
or a doubling time of less than 6 months.

7. 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.

Exclusion Criteria:

- 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.

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

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.

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Tracy Parrott

Investigator Role:

Study Director

Investigator Affiliation:

Tragara Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

TG02-102

NCT ID:

NCT01699152

Start Date:

September 2012

Completion Date:

August 2014

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma

Name

Location

DFCIBoston, Massachusetts  02215
SCRINashville, Tennessee  37203
OSUColumbus, Ohio  43210
GRUAugusta, Georgia  30912