Study Evaluating Venetoclax in Subjects With Hematological Malignancies
NCT ID: NCT02265731
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2014-09-22
2021-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A (Phase 1)
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)
venetoclax
Step-up doses of venetoclax to the designated cohort dose
Arm B (Phase 1)
Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
venetoclax
Step-up doses of venetoclax to the designated cohort dose
Arm C (Phase 1)
Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML)
azacitadine
75 mg/m2 by IV infusion or subcutaneous dosing
venetoclax
Step-up doses of venetoclax to the designated cohort dose
Arm D (Phase 2)
Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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NHO Nagoya Medical Center /ID# 129222
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital /ID# 129061
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 129278
Nagoya, Aichi-ken, Japan
University of Fukui Hospital /ID# 165801
Yoshida-gun, Fukui, Japan
National Hospital Organization Kyushu Cancer Center /ID# 149741
Fukuoka, Fukuoka, Japan
Kyushu University Hospital /ID# 163202
Fukuoka, Fukuoka, Japan
Kobe City Medical Center General Hospital /ID# 170919
Kobe, Hyōgo, Japan
Tohoku University Hospital /ID# 129275
Sendai, Miyagi, Japan
Kindai University Hospital /ID# 169554
Osakasayama-shi, Osaka, Japan
Osaka University Hospital /ID# 169862
Suita-shi, Osaka, Japan
National Cancer Center Hospital /ID# 129044
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 129277
Koto-ku, Tokyo, Japan
Toranomon Hospital /ID# 148229
Minato-ku, Tokyo, Japan
NTT Medical Center Tokyo /ID# 166281
Shinagawa-ku, Tokyo, Japan
Countries
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References
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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.
Other Identifiers
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M13-834
Identifier Type: -
Identifier Source: org_study_id
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