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Lymphoplasmacytic Lymphoma (LPL) is a rare type of low-grade B-cell lymphoma. The purpose of this study is to assess the change in disease activity of adult participants with relapsed or refractory Waldenström macroglobulinemia(WM)/LPL receiving venetoclax.
Venetoclax is being investigated in the treatment of WM/LPL. Participants will receive oral venetoclax at doses ramping up to the target dose, as part of treatment. Approximately 14 adult participants with WM/LPL will be enrolled in the study at approximately 20 sites in Japan.
Participants will receive oral venetoclax at doses ramping up to the target dose. The total study duration is approximately 28 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax Monotherapy | Experimental | Participants will receive venetoclax at doses ramping up to the target dose, as part of the approximately 28 month study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Major Response | Major response is defined as participants with a best overall response of complete response (CR), very good partial response (VGPR) or partial response (PR) per independent review committee (IRC) assessment according to International Workshop on Waldenstrom macroglobulinemia (WM) (IWWM)-11 criteria in participants with Immunoglobulin M (IgM) >= 500 mg/dL at screening. | Up to Approximately 28 Months |
| Number of Participants with Major Response in participants with IgM >= 500 mg/dL | Major response is defined as participants with a best overall response of CR, VGPR or PR per IRC assessment according to IWWM-11. | Up to Approximately 28 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as time from first study treatment to a documented disease progression (PD) according to IWWM-11 criteria, determined by investigator or death from any cause, whichever occurs first. | Up to Approximately 28 Months |
| Overall Survival (OS) |
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Inclusion Criteria:
Documented diagnosis of Waldenström macroglobulinemia(WM) /lymphoplasmacytic lymphoma (LPL) according to the 5th edition of the World Health Organization (WHO) classification and/or documented clinicopathological diagnosis of WM in accordance with the consensus panel of the second International Workshop on WM (IWWM).
At least one prior standard therapy for WM/LPL.
Measurable disease, defined as follows:
Requires systemic anti-cancer treatment for WM/LPL, according to the investigator.
Eastern Cooperative Oncology Group Performance Status < = 2
Adequate organ and bone marrow function
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 279178 | Recruiting | Nagoya | Aichi-ken | 466-8650 | Japan |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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OS is defined as time from first study treatment to death due to any cause. |
| Up to Approximately 28 Months |
| Overall Response (OR) | For participants with IgM >= 500 mg/dL at screening, overall response is defined as participants with a best overall response of CR, VGPR, PR or minor response (MR) per investigator assessment according to IWWM-11 criteria. For participants with IgM < 500 mg/dL at screening, overall response is defined as participants with the best overall response of CR or PR per investigator assessment according to Revised Response Criteria for Malignant Lymphoma. | Up to Approximately 28 Months |
| Duration of Response (DOR) | For participants with IgM >= 500 mg/dL at screening, DOR is defined as time from the initial response of CR, VGPR or PR per investigator review according to IWWM-11 criteria to PD or death of any cause, whichever occurs first. For participants with IgM < 500 mg/dL at screening, DOR is defined as time from the initial response of CR or PR per investigator review according to Revised Response Criteria for Malignant Lymphoma to PD or death of any cause, whichever occurs first. DOR will be summarized for the participants achieving overall response. | Up to Approximately 28 Months |
| Time to Next Treatment (TTNT) | TTNT is defined as time from first study treatment to the starting date of new anti-cancer therapy. | Up to Approximately 28 Months |
| Nagoya City University Hospital /ID# 277580 | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
| University of Fukui Hospital /ID# 279173 | Recruiting | Yoshida-gun | Fukui | 910-1104 | Japan |
| Kyushu University Hospital /ID# 277582 | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
| Gunma University Hospital /ID# 277576 | Recruiting | Maebashi | Gunma | 371-8511 | Japan |
| Hiroshima University Hospital /ID# 279172 | Recruiting | Hiroshima | Hiroshima | 734-8551 | Japan |
| NHO Mito Medical Center /ID# 279175 | Recruiting | Higashiibaraki-gun | Ibaraki | 311-3193 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 277584 | Recruiting | Kyoto | Kyoto | 602-8566 | Japan |
| Kindai University Hospital /ID# 277587 | Recruiting | Sakai-shi | Osaka | 590-0197 | Japan |
| The University of Tokyo Hospital /ID# 279174 | Recruiting | Bunkyo-ku | Tokyo | 113-8654 | Japan |
| National Cancer Center Hospital /ID# 279076 | Recruiting | Chuo-Ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital Of JFCR /ID# 277579 | Recruiting | Koto-ku | Tokyo | 135-8550 | Japan |
| Japanese Red Cross Medical Center /ID# 277577 | Recruiting | Shibuya-ku | Tokyo | 150-8935 | Japan |
| National Hospital Organization Disaster Medical Center /ID# 277741 | Recruiting | Tachikawa | Tokyo | 190-0014 | Japan |
| University of Yamanashi Hospital /ID# 279179 | Recruiting | Chuo-shi | Yamanashi | 409-3898 | Japan |
| Chiba Cancer Center /ID# 279177 | Recruiting | Chiba | 260-0801 | Japan |
| Nagano Red Cross Hospital /ID# 279774 | Recruiting | Nagano | 380-8582 | Japan |
| ID | Term |
|---|---|
| D008258 | Waldenstrom Macroglobulinemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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