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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Phase 1) | Experimental | Step-up doses of venetoclax to the designated cohort dose administered in participants with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) |
|
| Arm B (Phase 1) | Experimental | Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) |
|
| Arm C (Phase 1) | Experimental | Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML) |
|
| Arm D (Phase 2) | Experimental | Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azacitadine | Drug | 75 mg/m2 by IV infusion or subcutaneous dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants having treatment-emergent adverse events | Collect all adverse events at each visit | Approximately 2 years |
| Time to maximum plasma concentration (Tmax) of venetoclax | Approximately 8 days | |
| Maximum plasma concentration (Cmax) of venetoclax | Approximately 8 days | |
| Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax | Approximately 8 days | |
| Objective Response Rate (Phase 2) | The proportion of participants with response (e.g., partial, complete response) using IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants will be computed for all participants with active disease at baseline (in the opinion of the investigator). | Approximately 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (Phase 1) | The proportion of participants with response (e.g., partial, complete response) using IWG (International Working Group) response criteria for NHL participants, IMWG (International Myeloma Working Group) response criteria for multiple myeloma participants, IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants or IWG (International Working Group) criteria for AML participants will be computed for all participants with active disease at baseline (in the opinion of the investigator). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHO Nagoya Medical Center /ID# 129222 | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Aichi Cancer Center Hospital /ID# 129061 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33094474 | Background | Izutsu K, Yamamoto K, Kato K, Ishikawa T, Fukuhara N, Terui Y, Choi I, Humphrey K, Kim SY, Okubo S, Ogawa N, Nishimura Y, Salem AH, Maruyama D. Phase 1/2 study of venetoclax, a BCL-2 inhibitor, in Japanese patients with relapsed or refractory chronic lymphocytic leukemia and small lymphocytic lymphoma. Int J Hematol. 2021 Mar;113(3):370-380. doi: 10.1007/s12185-020-03024-3. Epub 2020 Oct 23. |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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| venetoclax |
| Drug |
Step-up doses of venetoclax to the designated cohort dose |
|
| rituximab / IDEC-C2B8 | Drug | 375 mg/m2 on Week 6 |
|
| rituximab / IDEC-C2B8 | Drug | 500 mg/m2 Week 10 Day 1 and thereafter |
|
| Approximately 48 months |
| Minimal Residual Disease (MRD) | Approximately 2 years |
| Duration of Response | Duration of response is defined as the number of days from the participant's initial response (e.g., partial, complete response per disease-appropriate response criteria) to the day that disease progression is objectively documented. | Approximately 48 months |
| Time to disease progression | Time to disease progression is defined as the number of days from the date the subject started the study drug to the date of the subject's progression (all events of progression will be included). | Approximately 48 months |
| complete response or remission (CR) rate | CR rate will be defined as the proportion of participants who achieved a complete response or remission (CR) or complete response with incomplete bone marrow recovery or complete remission with incomplete count recovery (CRi) per the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. | Approximately 48 months |
| Partial response or remission (PR) rate | PR rate will be defined as the proportion of subjects who achieved a nodular PR (nPR) or PR per the 2008 IWCLL criteria. | Approximately 48 months |
| Progression Free Survival (PFS) | Duration of progression-free survival (PFS) will be defined as the number of days from the date of first dose to the date of earliest disease progression or death. | Approximately 48 months |
| Nagoya |
| Aichi-ken |
| 464-8681 |
| Japan |
| Nagoya City University Hospital /ID# 129278 | Nagoya | Aichi-ken | 4678602 | Japan |
| University of Fukui Hospital /ID# 165801 | Yoshida-gun | Fukui | 910-1193 | Japan |
| National Hospital Organization Kyushu Cancer Center /ID# 149741 | Fukuoka | Fukuoka | 811-1395 | Japan |
| Kyushu University Hospital /ID# 163202 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Kobe City Medical Center General Hospital /ID# 170919 | Kobe | Hyōgo | 650-0047 | Japan |
| Tohoku University Hospital /ID# 129275 | Sendai | Miyagi | 9808574 | Japan |
| Kindai University Hospital /ID# 169554 | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Osaka University Hospital /ID# 169862 | Suita-shi | Osaka | 565-0871 | Japan |
| National Cancer Center Hospital /ID# 129044 | Chuo-ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital Of JFCR /ID# 129277 | Koto-ku | Tokyo | 135-8550 | Japan |
| Toranomon Hospital /ID# 148229 | Minato-ku | Tokyo | 105-8470 | Japan |
| NTT Medical Center Tokyo /ID# 166281 | Shinagawa-ku | Tokyo | 141-8625 | Japan |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015470 | Leukemia, Myeloid, Acute |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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