TGR1202 in Relapsed and Refractory Follicular Lymphoma

NCT03178201 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: AAAR1223
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the overall response rate (ORR) of TGR-1202 in R/R FL. Secondary Objectives

• Determine the genetic and other novel biological markers that may be predictive of response or resistance to TGR-1202 in patients with relapsed or refractory FL.
• Describe the Progression Free Survival (PFS), Duration of Response (DoR) after treatment with TGR-1202.
• Describe the number of dose delays and dose reductions and other safety profile.

Conditions

Follicular Lymphoma

Keywords

Relapsed follicular lymphoma; Refractory follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  The sum of patients with partial responses and complete responses.

  Up to 3 years

Secondary Outcomes (5)

• Progression Free Survival (PFS) After Treatment With TGR-1202

  Up to 3 years

• Duration of Response (DoR) After Treatment With TGR-1202

  Up to 3 years

• Number of Dose Delays

  Up to 3 years

• Number of Dose Reductions

  Up to 3 years

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  Up to 3 years

Study Arms (1)

TGR-1202

EXPERIMENTAL

Patients with relapsed or refractory grade 1, 2, or 3A follicular lymphoma will receive TGR-1202.

Drug: TGR-1202

Interventions

TGR-1202 DRUG

Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days.

Also known as: formerly as RP5307

TGR-1202

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven diagnosis of grade 1, 2, or 3A FL.
• Relapse following first line immunotherapy or chemoimmunotherapy. There is no upper limit to the number of therapies received prior to study entry. Prior therapies may include high-dose therapy with autologous stem cell rescue.
• Measurable Disease according to the Lugano classification.
• Lymphoma that is amenable to safe pre-treatment and post-treatment biopsy. The safety of the procedures will be determined by the treating physician and the surgeon in consultation with the PI, and in accordance with standard clinical practice. Acceptable sites of disease include, for example: (1) palpable tumor mass that is accessible under direct visualization or sonogram, (2) non-palpable tumor tissue that is accessible for biopsy under computed tomography (CT) or sonogram guidance, (3) bone marrow.
• Age \>18 years
• Eastern Cooperative Oncology Group (ECOG) performance status \<2
• Patients must have adequate organ and marrow function as defined below:
• absolute neutrophil count \>1,000/microliter
• platelet count ≥50,000/microliter
• bilirubin \<1.5 x institutional upper limit of normal
• aspartate transaminase (AST, SGOT)/alanine transaminase (ALT, SGPT) \<3.0 x institutional upper limit of normal
• Serum creatinine \<2.0 x institutional upper limit of normal or creatinine clearance \>50 mL/min (according to the Cockcroft and Gault equation).
• Negative serum pregnancy test within 7 days prior to Cycle 1/Day 1 for women of childbearing potential.
• All women of childbearing potential must agree to use an effective barrier method of contraception, as described in Appendix 4, during the treatment period and for at least 1 month after discontinuation of the study drug. Male subjects should use effective barrier method of contraception during the treatment period and for at least 1 month after discontinuation of the study drug
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Grade 3B FL or evidence of transformation to a more aggressive lymphoma
• Prior and concomitant therapy:
• Prior exposure to any PI3 Kinase inhibitor
• Exposure to chemotherapy, radiotherapy, or immunotherapy within 3 weeks prior to entering the study or lack of recovery from adverse events (AE) due to previously administered treatments.
• Ongoing chronic immunosuppressants (e.g. cyclosporine) or systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drug.
• Other concurrent investigational agents during the study period.
• Prior allogeneic stem cell transplant
• Central nervous system lymphoma, including lymphomatous meningitis
• Acute intercurrent illness including, but not limited to, active infection, unstable congestive heart failure, unstable angina pectoris, psychiatric illness or any social situation that would limit compliance with study participation requirements in the judgement of the investigator.
• Major surgery performed within 4 weeks of study entry
• Pregnant or nursing women
• Active concurrent malignancy (except non-invasive non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3-years at the time of study entry.
• Documented Human Immunodeficiency Virus (HIV)-infection
• Active hepatitis A, hepatitis B, or hepatitis C infection
• History of tuberculosis treatment within 2 years of study entry

Sponsors & Collaborators

• Columbia University: lead
• TG Therapeutics, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

umbralisib; rhoA GTP-Binding Protein

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins

Results Point of Contact

• Title: Ana Ignat
• Organization: Columbia University

ai2111@cumc.columbia.edu

212-305-3612

Study Officials

• Changchun Deng, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 6, 2017
• Study Start: August 20, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 16, 2021
• Results First Posted: July 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)