Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02867618
Eligibility Criteria:
Target Population Phase I: Patients with relapsed or refractory NHL and HL Phase II: Patients with relapsed or refractory NHL
Inclusion Criteria:
* Phase I: Patients must have histologically confirmed R/R NHL or HL (defined by World Health Organization (WHO) criteria). Patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible. In addition, patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL and HL will be eligible if there is no available standard therapy.
* Phase II: Patients must have histologically confirmed R/R NHL (as defined by WHO criteria). Patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL will be eligible if there is no available standard therapy.
* Must have received front line chemotherapy. No upper limit for the number of prior therapies
* Evaluable Disease in the Phase I, and measurable disease in the Phase II
* Age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Patients must have adequate organ and marrow function
* Adequate Contraception
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Prior Therapy Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs. No other investigational agents are allowed.
2. History of allergic reactions to TGR-1202 or carfilzomib
3. Uncontrolled inter-current illness
4. Pregnant women
5. Nursing women
6. Current malignancy or history of a prior malignancy
7. Patient known to be Human Immunodeficiency Virus (HIV)-positive
8. Active Hepatitis A, Hepatitis B, or Hepatitis C infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02867618
Study Brief:
Protocol Section:
NCT02867618