Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT04204057
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2019-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706530', 'term': 'tenalisib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pjb@rhizen.com', 'phone': '+41325800175', 'title': 'Prajak Barde MD', 'organization': 'Rhizen Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 months', 'eventGroups': [{'id': 'EG000', 'title': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles\n\nTenalisib: Tenalisib 800 mg BID, Orally', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 15, 'seriousNumAtRisk': 21, 'deathsNumAffected': 2, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 18, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles\n\nTenalisib: Tenalisib 800 mg BID, Orally'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '14.59', 'upperLimit': '56.97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 Months', 'description': 'Per Response Evaluation Criteria as defined by iwCLL guideline for CLL: Complete Response (CR), all parameters should be regressed to normal (lymph nodes ≥ 1.5 cm; spleen size \\<13 cm; liver size normal; no constitutional symptoms; circulating lymphocyte count normal; platelet count ≥ 100 x 109 /L; Hemoglobin ≥ 11.0 g/dL). For partial response, at least two of the parameters (lymph nodes, liver and/or spleen size, constitutional symptoms, circulating lymphocyte count) and one parameter (platelet count, hemoglobin) need to improve if previously abnormal; Overall Response (OR) = CR + PR."', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received at least 1 dose of study medication and provided at least 1 post-baseline efficacy assessment'}, {'type': 'PRIMARY', 'title': 'Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles\n\nTenalisib: Tenalisib 800 mg BID, Orally'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '148'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '7 Months', 'description': 'Duration of response (DOR): DOR is defined as the interval from the first documentation of CR/PR to the first documentation of definitive disease progression or death from any cause.\n\nProgression disease is defined using iwCLL criteria as at least one of the criteria of parameters (i.e., lymph nodes increase ≥ 50% from baseline or from response; liver and/or spleen size increase ≥ 50% from baseline or from response; any constitutional symptoms; circulating lymphocyte count increase ≥ 50% over baseline) or criteria of parameters (i.e., platelet count decrease of ≥ 50% over baseline secondary to CLL; hemoglobin decrease of ≥ 50% over baseline secondary to CLL) should be met.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received at least 1 dose of study medication and provide at least post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles\n\nTenalisib: Tenalisib 800 mg BID, Orally'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 Months', 'description': 'Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received at least 1 dose of study medication'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles\n\nTenalisib: Tenalisib 800 mg BID, Orally'}], 'classes': [{'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000', 'lowerLimit': '198', 'upperLimit': '205'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '7 months', 'description': 'Progression-free survival (PFS): PFS is defined as the interval from first dose to first documentation of definitive disease progression or death from any cause.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received at least 1 dose of study medication and provide at least 1 post-baseline efficacy assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles\n\nTenalisib: Tenalisib 800 mg BID, Orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles\n\nTenalisib: Tenalisib 800 mg BID, Orally'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.08', 'groupId': 'BG000', 'lowerLimit': '44.93', 'upperLimit': '79.27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Poland', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-12', 'size': 1320190, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-02T05:20', 'hasProtocol': True}, {'date': '2020-12-14', 'size': 613013, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-02T05:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (open label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-10', 'studyFirstSubmitDate': '2019-12-04', 'resultsFirstSubmitDate': '2021-07-02', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-02', 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': '7 Months', 'description': 'Per Response Evaluation Criteria as defined by iwCLL guideline for CLL: Complete Response (CR), all parameters should be regressed to normal (lymph nodes ≥ 1.5 cm; spleen size \\<13 cm; liver size normal; no constitutional symptoms; circulating lymphocyte count normal; platelet count ≥ 100 x 109 /L; Hemoglobin ≥ 11.0 g/dL). For partial response, at least two of the parameters (lymph nodes, liver and/or spleen size, constitutional symptoms, circulating lymphocyte count) and one parameter (platelet count, hemoglobin) need to improve if previously abnormal; Overall Response (OR) = CR + PR."'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': '7 Months', 'description': 'Duration of response (DOR): DOR is defined as the interval from the first documentation of CR/PR to the first documentation of definitive disease progression or death from any cause.\n\nProgression disease is defined using iwCLL criteria as at least one of the criteria of parameters (i.e., lymph nodes increase ≥ 50% from baseline or from response; liver and/or spleen size increase ≥ 50% from baseline or from response; any constitutional symptoms; circulating lymphocyte count increase ≥ 50% over baseline) or criteria of parameters (i.e., platelet count decrease of ≥ 50% over baseline secondary to CLL; hemoglobin decrease of ≥ 50% over baseline secondary to CLL) should be met.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0', 'timeFrame': '7 Months', 'description': 'Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '7 months', 'description': 'Progression-free survival (PFS): PFS is defined as the interval from first dose to first documentation of definitive disease progression or death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phosphoinositide 3-kinase', 'Pi3k Delta and gamma inhibitor', 'Tenalisib', 'Leukemia, Lymphocytic, Chronic, B-Cell'], 'conditions': ['Leukemia, Lymphocytic, Chronic, B-Cell']}, 'descriptionModule': {'briefSummary': "The trial is a Phase II, open label, Simon's two stage study design to evaluate the efficacy and safety of Tenalisib in patients with CLL who have relapsed or are refractory after at least one prior therapy.", 'detailedDescription': 'Tenalisib is a highly specific and orally available dual PI3K δ/γ inhibitor. Pre-clinical experiments demonstrated that Tenalisib is highly effective in killing primary CLL cells in vitro. A Phase II study is planned to evaluate the efficacy and safety of Tenalisib in patients with relapsed/refractory CLL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with diagnosis of B-cell CLL\n2. Disease status defined as refractory to or relapsed after at least one prior therapy.\n3. Presence of measurable lymphadenopathy presence of \\> 1 nodal lesion\n4. ECOG performance status ≤ 2.\n5. Adequate bone marrow, liver, and renal function\n\nExclusion Criteria:\n\n1. Richter's (large cell) transformation, or PLL transformation.\n2. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).\n3. Prior exposure to drug that inhibits PI3K\n4. Patient with ASCT/Allo-SCT receiving treatment for active GVHD.\n5. Ongoing severe systemic bacterial, fungal or viral infection.\n6. Central nervous system (CNS) involvement of leukemia or lymphoma.\n7. Ongoing immunosuppressive therapy including systemic corticosteroids.\n8. Known history of severe liver injury as judge by investigator.\n9. Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation\n10. Women who are pregnant or lactating.\n11. Known seropositive requiring anti-viral therapy for i. human immunodeficiency virus (HIV) infection. ii. hepatitis B virus (HBV) infection iii. hepatitis c virus (HCV) infection iv. active CMV infection\n\n \\-"}, 'identificationModule': {'nctId': 'NCT04204057', 'briefTitle': 'Efficacy and Safety of Tenalisib (RP6530) in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhizen Pharmaceuticals SA'}, 'officialTitle': 'A Phase 2, Open Label Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a Novel PI3K Dual δ/γ Inhibitor, in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)', 'orgStudyIdInfo': {'id': 'RP6530-1901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenalisib', 'description': 'Patients receive Tenalisib 800 mg BID, Orally in 28-Day cycle for 7 cycles', 'interventionNames': ['Drug: Tenalisib']}], 'interventions': [{'name': 'Tenalisib', 'type': 'DRUG', 'otherNames': ['RP6530'], 'description': 'Tenalisib 800 mg BID, Orally', 'armGroupLabels': ['Tenalisib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment "Dr Georgi Stranski" Ltd.,', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment "Sv Ivan Rilski" Ltd', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ltd. M.Zodelava Hematology Centre', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Medivest - Institute of Hematology and Transfusiology', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '41-503', 'city': 'Chorzów', 'country': 'Poland', 'facility': 'Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Voivodship Multi-Specialist Center for Oncology and Traumatology M. Copernicus', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhizen Pharmaceuticals SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}