Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination With Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304
| Verified date | May 2023 |
| Source | TG Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).
| Status | Terminated |
| Enrollment | 116 |
| Est. completion date | July 11, 2022 |
| Est. primary completion date | May 26, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Prior treatment in clinical trial UTX-TGR-304 - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: - Participants refractory to ublituximab + TGR-1202 - Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation) |
| Country | Name | City | State |
|---|---|---|---|
| Italy | TG Therapeutics Investigational Trial Site | Ferrara | |
| Italy | TG Therapeutics Investigational Trial Site | Milan | |
| Italy | TG Therapeutics Investigational Trial Site | Milan | |
| Italy | TG Therapeutics Investigational Trial Site | Torino | |
| Poland | TG Therapeutics Investigational Trial Site | Chorzów | |
| Poland | TG Therapeutics Investigational Trial Site | Gdynia | |
| Poland | TG Therapeutics Investigational Trial Site | Kraków | |
| Poland | TG Therapeutics Investigational Trial Site | Lódz | |
| Poland | TG Therapeutics Investigational Trial Site | Lublin | |
| Poland | TG Therapeutics Investigational Trial Site | Slupsk | |
| Poland | TG Therapeutics Investigational Trial Site | Warszawa | |
| Poland | TG Therapeutics Investigational Trial Site | Warszawa | |
| Poland | TG Therapeutics Investigational Trial Site | Warszawa | |
| Poland | TG Therapeutics Investigational Trial Site | Warszawa | |
| United Kingdom | TG Therapeutics Investigational Trial Site | London | |
| United Kingdom | TG Therapeutics Investigational Trial Site | Norwich | |
| United Kingdom | TG Therapeutics Investigational Trial Site | Sunderland | |
| United Kingdom | TG Therapeutics Investigational Trial Site | Wolverhampton | |
| United States | TG Therapeutics Investigational Trial Site | Albany | Georgia |
| United States | TG Therapeutics Investigational Trial Site | Ann Arbor | Michigan |
| United States | TG Therapeutics Investigational Trial Site | Aurora | Colorado |
| United States | TG Therapeutics Investigational Trial Site | Blacksburg | Virginia |
| United States | TG Therapeutics Investigational Trial Site | Boca Raton | Florida |
| United States | TG Therapeutics Investigational Trial Site | Bridgeport | Connecticut |
| United States | TG Therapeutics Investigational Trial Site | Camp Hill | Pennsylvania |
| United States | TG Therapeutics Investigational Trial Site | Canton | Ohio |
| United States | TG Therapeutics Investigational Trial Site | Chandler | Arizona |
| United States | TG Therapeutics Investigational Trial Site | Charlotte | North Carolina |
| United States | TG Therapeutics Investigational Trial Site | Charlottesville | Virginia |
| United States | TG Therapeutics Investigational Trial Site | Chattanooga | Tennessee |
| United States | TG Therapeutics Investigational Trial Site | Chicago | Illinois |
| United States | TG Therapeutics Investigational Trial Site | Denver | Colorado |
| United States | TG Therapeutics Investigational Trial Site | Detroit | Michigan |
| United States | TG Therapeutics Investigational Trial Site | Duarte | California |
| United States | TG Therapeutics Investigational Trial Site | Durham | North Carolina |
| United States | TG Therapeutics Investigational Trial Site | Durham | North Carolina |
| United States | TG Therapeutics Investigational Trial Site | Fayetteville | Arkansas |
| United States | TG Therapeutics Investigational Trial Site | Fort Belvoir | Virginia |
| United States | TG Therapeutics Investigational Trial Site | Fort Myers | Florida |
| United States | TG Therapeutics Investigational Trial Site | Fort Wayne | Indiana |
| United States | TG Therapeutics Investigational Trial Site | Fort Worth | Texas |
| United States | TG Therapeutics Investigational Trial Site | Glens Falls | New York |
| United States | TG Therapeutics Investigational Trial Site | Greenville | South Carolina |
| United States | TG Therapeutics Investigational Trial Site | Hershey | Pennsylvania |
| United States | TG Therapeutics Investigational Trial Site | Hickory | North Carolina |
| United States | TG Therapeutics Investigational Trial Site | Huntsville | Alabama |
| United States | TG Therapeutics Investigational Trial Site | Indianapolis | Indiana |
| United States | TG Therapeutics Investigational Trial Site | Jackson | Michigan |
| United States | TG Therapeutics Investigational Trial Site | Jacksonville | Florida |
| United States | TG Therapeutics Investigational Trial Site | Jacksonville | Florida |
| United States | TG Therapeutics Investigational Trial Site | Kansas City | Missouri |
| United States | TG Therapeutics Investigational Trial Site | Kinston | North Carolina |
| United States | TG Therapeutics Investigational Trial Site | Lebanon | New Hampshire |
| United States | TG Therapeutics Investigational Trial Site | Lincoln | Nebraska |
| United States | TG Therapeutics Investigational Trial Site | Louisville | Kentucky |
| United States | TG Therapeutics Investigational Trial Site | Morristown | New Jersey |
| United States | TG Therapeutics Investigational Trial Site | Nashville | Tennessee |
| United States | TG Therapeutics Investigational Trial Site | New Haven | Connecticut |
| United States | TG Therapeutics Investigational Trial Site | Newark | Delaware |
| United States | TG Therapeutics Investigational Trial Site | Ogden | Utah |
| United States | TG Therapeutics Investigational Trial Site | Pawtucket | Rhode Island |
| United States | TG Therapeutics Investigational Trial Site | Peoria | Illinois |
| United States | TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania |
| United States | TG Therapeutics Investigational Trial Site | Pittsburgh | Pennsylvania |
| United States | TG Therapeutics Investigational Trial Site | Pleasanton | California |
| United States | TG Therapeutics Investigational Trial Site | Portland | Oregon |
| United States | TG Therapeutics Investigational Trial Site | Portland | Oregon |
| United States | TG Therapeutics Investigational Trial Site | Saint Louis Park | Minnesota |
| United States | TG Therapeutics Investigational Trial Site | Saint Petersburg | Florida |
| United States | TG Therapeutics Investigational Trial Site | San Antonio | Texas |
| United States | TG Therapeutics Investigational Trial Site | San Diego | California |
| United States | TG Therapeutics Investigational Trial Site | Seattle | Washington |
| United States | TG Therapeutics Investigational Trial Site | Sioux Falls | South Dakota |
| United States | TG Therapeutics Investigational Trial Site | Spokane | Washington |
| United States | TG Therapeutics Investigational Trial Site | Springfield | Oregon |
| United States | TG Therapeutics Investigational Trial Site | Stamford | Connecticut |
| United States | TG Therapeutics Investigational Trial Site | Swansea | Illinois |
| United States | TG Therapeutics Investigational Trial Site | Syracuse | New York |
| United States | TG Therapeutics Investigational Trial Site | Tallahassee | Florida |
| United States | TG Therapeutics Investigational Trial Site | Toledo | Ohio |
| United States | TG Therapeutics Investigational Trial Site | Urbana | Illinois |
| United States | TG Therapeutics Investigational Trial Site | Washington | North Carolina |
| United States | TG Therapeutics Investigational Trial Site | Wauwatosa | Wisconsin |
| United States | TG Therapeutics Investigational Trial Site | West Palm Beach | Florida |
| United States | TG Therapeutics Investigational Trial Site | Westwood | Kansas |
| United States | TG Therapeutics Investigational Trial Site | Whittier | California |
| United States | TG Therapeutics Investigational Trial Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| TG Therapeutics, Inc. |
United States, Italy, Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria | ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR: No evidence of new disease; Absolute lymphocyte count(ALC)<4x10^9/liter(L); Regression of all target nodal masses to =1.5 centimeters (cm) in longest diameter(LD); Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; Absolute neutrophil count(ANC)>1.5x10^9/L,platelets=100x10^9/L,hemoglobin (Hgb)=110 gram per liter(g/L). PR: No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC<4x10^9/L or =50% decrease from baseline in sum of products(SPD) of target nodal lesions; splenomegaly; hepatomegaly;=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules; response in any 1:ANC>1.5x10^9/L,platelets>100x10^9/L,Hgb>110g/L or =50% increase over baseline in any of these. | Up to 76 months | |
| Primary | Complete Response (CR) Rate Per iwCLL Criteria | The CR rate was defined as the percentage of participants who achieved CR. CR: No evidence of new disease; ALC <4 x 10^9/L; Regression of all target nodal masses to normal size =1.5 cm in the LD; Normal spleen and liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC >1.5 x 10^9/L, platelets =100 x 10^9/L, Hgb =110 g/L. | Up to 76 months | |
| Primary | Progression-Free Survival (PFS) Per iwCLL Criteria | PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes >1.5 cm in the LD and >1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, =50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, =50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of =50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, >50% decrease from the highest on-study platelet count, >20 g/L decrease from the highest on-study Hgb. | Up to 76 months | |
| Primary | Duration of Response (DOR) | DOR:Interval from first documentation of CR/PR to first documentation of PD or death from any cause.CR:ALC<4x10^9/L;Regression to normal of target nodal masses,nodal non-target disease,and no detectable non-nodal,non-target disease;Normal spleen,liver size;Morphologically negative bone marrow,No lymphoid nodules;ANC>1.5x10^9/L,Platelets=100x10^9/L,Hgb=110 g/L.PR:Response in 2 or more:ALC<4x10^9/L, =50% drop from baseline in ALC or SPD of target nodal lesions,Hepatosplenomegaly,=50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;Response in 1 or more:ANC>1.5x10^9/L,Platelets>100x10^9/L,Hgb>110 g/L or =50% increase over baseline in any.PD:Response in 1 or more:new nodes,Hepatosplenomegaly,unequivocal extra-nodal lesion;=50% increase from nadir in SPD of target lesions or LD of node/extra-nodal mass or Splenic/Hepatic size,Unequivocal increase in non-target disease,More aggressive histology;Drop of >50% in platelets/>20g/L in Hgb from highest on-study count. | Up to 76 months | |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | MRD negativity rate is defined as the percentage of participants who are MRD negative. If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow. | From Cycle 6 until Cycle 15 (cycle length=28 days) (Up to approximately 76 months) | |
| Secondary | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related. | Up to 78 months |
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