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Clinical Trial 19585

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04163718

Phase: Phase II
Principal Investigator: Pinilla-Ibarz, Javier

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 2 Study to Assess the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Parameters of Umbralisib in Treatment Naïve Patients with Chronic Lymphocytic Leukemia (CLL)

Summary

The purpose of this study is to determine the safety and efficacy of Umbralisib (TGR-1202) in individuals with Chronic Lymphocytic Leukemia (CLL)

Objective

PRIMARY OBJECTIVE To evaluate the overall response rate (CR + PR) To determine the progression free survival of TGR-1202 (umbralisib) in patients with CLL SECONDARY OBJECTIVES To assess safety of TGR-1202 (umbralisib), tolerability and other efficacy outcome To determine the pharmacokinetics and pharmacodynamics of TGR-1202 (umbralisib)

Treatments

Therapies

Therapy (NOS)

Medications

TGR-1202 ()

Inclusion Criteria

Have a diagnosis of B-cell Chronic Lymphocytic Leukemia (CLL) that has not been previously treated and now warrants treatment consistent with accepted iwCLL criteria (Hallek 2018) for initiation of therapy. Any one of the following conditions constitute CLL that warrants treatment: (a) Evidence of progressive marrow failure as manifested by the onset or worsening of anemia and/or thrombocytopenia, or (b) Massive (i.e., lower edge of spleen >/=6 cm below the left costal margin), progressive, or symptomatic splenomegaly, or (c) Massive (i.e., >/=10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy, or (d) Progressive lymphocytosis in the absence of infection, with an increase in blood absolute lymphocyte count (ALC) >50% over a 2-month period or lymphocyte doubling time of /=30,000/µL), or (e) Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy, or (f) Symptomatic or functional extranodal involvement (e.g. skin, kidney, lung, or spine), or (g) Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs occurring in the absence of evidence of infection: (i) Unintentional weight loss of >/=10% within the previous 6 months, or (ii) Significant fatigue (>/=Grade 2), or (iii) Fevers >100.5°F or 38.0°C for >/=2 weeks, or (iv) Night sweats for >1 month.

Adequate organ system function as defined per protocol.

ECOG performance status ≤ 2

Male or female 18 years of age or older.

Ability to swallow and retain oral medication

Female participants who are not of child-bearing potential and female participants of child-bearing potential who have a negative serum pregnancy test within 3 days prior to Cycle 1, Day 1.

Female participants of child-bearing potential and all male partners, and male participants must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after the last dose of study drug. 7) Willingness and ability to comply with trial and follow-up procedures, and give written informed consent

Exclusion Criteria

Has ever received any form of treatment for CLL.

Corticosteroid therapy of prednisone > 10 mg or equivalent started at least 7 days prior to Cycle 1, Day 1 is prohibited. Prednisone > Prior treatment with umbralisib.

Prior treatment with autologous hematologic stem cell transplant or prior Allogeneic hematologic stem cell transplant is excluded.

Evidence of chronic active Hepatitis B (HBV, not including participants with prior hepatitis B vaccination; or positive serum Hepatitis B antibody) or chronic active Hepatitis C infection (HCV), active cytomegalovirus (CMV), or known history of HIV. If HBc antibody is positive the participant must be evaluated for the presence of HBV DNA by PCR. If HCV antibody is positive, the participant must be evaluated for the presence of HCV RNA by PCR. See Appendix C. If the participant is CMV IgG or CMV IgM positive, the participant must be evaluated for the presence of CMV DNA by PCR. Participants with positive HBc antibody and negative HBV DNA by PCR are eligible. Participants with positive HCV antibody and negative HCV RNA by PCR are eligible. Participants who are CMV IgG or CMV IgM positive but who are CMV DNA negative by PCR are eligible. Antiviral prophylaxis should be considered per institutional protocol.

Known histological transformation from CLL to an aggressive lymphoma (i.e. Richters transformation / Hodgkin Lymphoma).

Evidence of ongoing systemic bacterial, fungal or viral infection, except localized fungal infection of skin/nails. NOTE: Participants may be receiving prophylactic antiviral or antibacterial therapies at investigator discretion. Use of anti-pneumocystis and antiviral prophylaxis is required.

Inflammatory bowel disease (such as Crohns disease or ulcerative colitis)

Malabsorption syndromes

Irritable bowel syndrome with greater than 3 loose stools per day as a baseline.

Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.

Malignancy, including myelodysplastic syndromes, within 3 years of study enrollment except for basal, squamous cell carcinoma melanoma in situ, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer following curative treatment and with a normal PSA level.

Women who are pregnant or lactating.

Participants requiring immediate cytoreductive therapy.

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