Carfilzomib and TGR-1202 in Treatment of R/R Lymphoma
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ClinicalTrials.gov Identifier: NCT02867618 |
Recruitment Status :
Terminated
(PI left institution)
First Posted : August 16, 2016
Results First Posted : July 16, 2021
Last Update Posted : July 16, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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Hodgkin Disease Lymphoma, Non-hodgkin | Drug: Carfilzomib Drug: TGR-1202 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of Carfilzomib and a PI3Kdelta Inhibitor TGR-1202 in the Treatment of Patients With Relapsed or Refractory Lymphoma |
Actual Study Start Date : | October 16, 2016 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | June 30, 2020 |

Arm | Intervention/treatment |
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Experimental: Carfilzomib + TGR-1202
Oral TGR-1202 will be given PO once daily on Days 1-28 and carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle.
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Drug: Carfilzomib
Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202
Other Name: Kyprolis Drug: TGR-1202 Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib
Other Name: (formerly) RP-5264 |
- Maximum Tolerated Dose (MTD) (Phase 1) - TGR-1202 Only [ Time Frame: 9 months ]The highest dose of the study treatment that does not cause unacceptable side effects.
- Objective Response Rate (ORR) (Phase 2) [ Time Frame: 9 months ]Defined as best response (complete response and partial response) by 4 cycles.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- 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.
- History of allergic reactions to TGR-1202 or carfilzomib
- Uncontrolled inter-current illness
- Pregnant women
- Nursing women
- Current malignancy or history of a prior malignancy
- Patient known to be Human Immunodeficiency Virus (HIV)-positive
- Active Hepatitis A, Hepatitis B, or Hepatitis C infection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867618
United States, New York | |
Columbia University Irving Medical Center - Center for Lymphoid Malignancies | |
New York, New York, United States, 10019 |
Principal Investigator: | Changchun Deng, MD | Assistant Professor of Clinical Medicine and Experimental Therapeutics |
Documents provided by Columbia University:
Responsible Party: | Columbia University |
ClinicalTrials.gov Identifier: | NCT02867618 |
Other Study ID Numbers: |
AAAP5661 |
First Posted: | August 16, 2016 Key Record Dates |
Results First Posted: | July 16, 2021 |
Last Update Posted: | July 16, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |