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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02265731
Other study ID # M13-834
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 22, 2014
Est. completion date March 12, 2021

Study information

Verified date July 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date March 12, 2021
Est. primary completion date March 12, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Participants must have histologically documented diagnosis of NHL (and exhausted options considered standard of care) as defined in the World Health Organization classification scheme and relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. Participants with other lymphoproliferative diseases can be considered in consultation with the AbbVie medical monitor - Relapsed or refractory multiple myeloma participants must have been previously treated with at least one prior line of therapy and have measurable disease - Chronic lymphocytic leukemia/small lymphocytic lymphoma participants must have relapsed or be refractory to standard treatments such as fludarabine based regimens or alkylator based regimens - Untreated AML subjects or Relapsed or refractory AML subjects must have been previously treated with at least one prior line of therapy - Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1; adequate bone marrow independent of growth factor support per local laboratory reference range; and adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening - Participants with a history of autologous or allogenic stem cell transplantation must have adequate blood counts independent of growth factor support and have recovered from any transplant-related toxicity(s) and be at least 100 days post-autologous transplant (multiple myeloma) or 6 month post-autologous transplant (NHL) prior to first dose of study drug or at least 6 months post-allogenic transplant (multiple myeloma) prior to first dose of study drug and not have active graft-versus-host disease (GVHD), i.e., requiring treatment Exclusion Criteria: - NHL participants who have undergone an allogeneic stem cell transplant or were diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia - Participant tested positive for HIV - Participant has a cardiovascular disability status of New York Heart Association Class greater or equal to 2 - Participant has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study. - Participant received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.

Study Design


Intervention

Drug:
azacitadine
75 mg/m2 by IV infusion or subcutaneous dosing
venetoclax
Step-up doses of venetoclax to the designated cohort dose
rituximab / IDEC-C2B8
375 mg/m2 on Week 6
rituximab / IDEC-C2B8
500 mg/m2 Week 10 Day 1 and thereafter

Locations

Country Name City State
Japan National Cancer Center Hospital /ID# 129044 Chuo-ku Tokyo
Japan Kyushu University Hospital /ID# 163202 Fukuoka-shi Fukuoka
Japan National Hospital Organization Kyushu Cancer Center /ID# 149741 Fukuoka-shi Fukuoka
Japan Kobe City Medical Center General Hospital /ID# 170919 Kobe-shi Hyogo
Japan The Cancer Institute Hospital Of JFCR /ID# 129277 Koto-ku Tokyo
Japan Toranomon Hospital /ID# 148229 Minato-ku Tokyo
Japan Nagoya City University Hospital /ID# 129278 Nagoya shi Aichi
Japan Aichi Cancer Center Hospital /ID# 129061 Nagoya-shi Aichi
Japan NHO Nagoya Medical Center /ID# 129222 Nagoya-shi Aichi
Japan Kindai University Hospital /ID# 169554 Osakasayama-shi Osaka
Japan Tohoku University Hospital /ID# 129275 Sendai-shi Miyagi
Japan NTT Medical Center Tokyo /ID# 166281 Shinagawa-ku Tokyo
Japan Osaka University Hospital /ID# 169862 Suita-shi Osaka
Japan University of Fukui Hospital /ID# 165801 Yoshida-gun Fukui

Sponsors (2)

Lead Sponsor Collaborator
AbbVie Genentech, Inc.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants having treatment-emergent adverse events Collect all adverse events at each visit Approximately 2 years
Primary Time to maximum plasma concentration (Tmax) of venetoclax Approximately 8 days
Primary Maximum plasma concentration (Cmax) of venetoclax Approximately 8 days
Primary Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax Approximately 8 days
Primary 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
Secondary 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). Approximately 48 months
Secondary Minimal Residual Disease (MRD) Approximately 2 years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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