Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma

• Status: Terminated
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, phase I/II, dose-escalation study in the initial phase I followed by a phase II.

The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of TGR-1202 and carfilzomib in participants with relapsed and refractory (R/R) non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). The safety and toxicity of this combination will be evaluated throughout the entire study.

If the combination of TGR-1202 and carfilzomib is found to be feasible and an MTD is established, the phase II part of the study will be initiated.

Phase II will consist of a 2-stage design of the combination of TGR-1202 and carfilzomib for participants with R/R NHL.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changchun Deng; Columbia University

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