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Trial record 37 of 128 for:    Venetoclax AND complete response

Study Evaluating Venetoclax in Subjects With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT02265731
Recruitment Status : Active, not recruiting
First Posted : October 16, 2014
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma (NHL) Multiple Myeloma (MM) Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) Acute Myeloid Leukemia (AML) Drug: azacitadine Drug: venetoclax Drug: rituximab / IDEC-C2B8 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Japanese Subjects With Hematological Malignancies
Actual Study Start Date : September 22, 2014
Estimated Primary Completion Date : February 6, 2020
Estimated Study Completion Date : February 6, 2020


Arm Intervention/treatment
Experimental: 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)
Drug: venetoclax
Step-up doses of venetoclax to the designated cohort dose

Experimental: 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)
Drug: venetoclax
Step-up doses of venetoclax to the designated cohort dose

Experimental: 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)
Drug: azacitadine
75 mg/m2 by IV infusion or subcutaneous dosing

Drug: venetoclax
Step-up doses of venetoclax to the designated cohort dose

Experimental: Arm D (Phase 2)
Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL
Drug: venetoclax
Step-up doses of venetoclax to the designated cohort dose

Drug: rituximab / IDEC-C2B8
375 mg/m2 on Week 6

Drug: rituximab / IDEC-C2B8
500 mg/m2 Week 10 Day 1 and thereafter




Primary Outcome Measures :
  1. Number of participants having treatment-emergent adverse events [ Time Frame: Approximately 2 years ]
    Collect all adverse events at each visit

  2. Time to maximum plasma concentration (Tmax) of venetoclax [ Time Frame: Approximately 8 days ]
  3. Maximum plasma concentration (Cmax) of venetoclax [ Time Frame: Approximately 8 days ]
  4. Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax [ Time Frame: Approximately 8 days ]
  5. Objective Response Rate (Phase 2) [ Time Frame: Approximately 48 months ]
    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).


Secondary Outcome Measures :
  1. Objective Response Rate (Phase 1) [ Time Frame: Approximately 48 months ]
    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).

  2. Minimal Residual Disease (MRD) [ Time Frame: Approximately 2 years ]
  3. Duration of Response [ Time Frame: Approximately 48 months ]
    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.

  4. Time to disease progression [ Time Frame: Approximately 48 months ]
    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).

  5. complete response or remission (CR) rate [ Time Frame: Approximately 48 months ]
    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.

  6. Partial response or remission (PR) rate [ Time Frame: Approximately 48 months ]
    PR rate will be defined as the proportion of subjects who achieved a nodular PR (nPR) or PR per the 2008 IWCLL criteria.

  7. Progression Free Survival (PFS) [ Time Frame: Approximately 48 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265731


Locations
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Japan
Aichi Cancer Center Hospital /ID# 129061
Nagoya-shi, Aichi, Japan, 464-8681
Nagoya City University Hospital /ID# 129278
Nagoya-shi, Aichi, Japan, 467-8602
University of Fukui Hospital /ID# 165801
Yoshida-gun, Fukui, Japan, 910-1193
National Hospital Organization Kyushu Cancer Center /ID# 149741
Fukuoka-shi, Fukuoka, Japan, 811-1395
Kyushu University Hospital /ID# 163202
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kobe City Medical Center General Hospital /ID# 170919
Kobe-shi, Hyogo, Japan, 650-0047
Tohoku University Hospital /ID# 129275
Sendai-shi, Miyagi, Japan, 980-8574
Kinki University -Osakasayama Campus /ID# 169554
Osakasayama-shi, Osaka, Japan, 589-8511
Osaka University Hospital /ID# 169862
Suita-shi, Osaka, Japan, 565-0871
National Cancer Center Hospital /ID# 129044
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hosp JFCR /ID# 129277
Koto-ku, Tokyo, Japan, 135-8550
Toranomon Hospital /ID# 148229
Minato-ku, Tokyo, Japan, 105-8470
NTT Medical Center Tokyo /ID# 166281
Shinagawa-ku, Tokyo, Japan, 141-8625
NHO Nagoya Medical Center /ID# 129222
Nagoya, Japan, 460-0001
Sponsors and Collaborators
AbbVie
Genentech, Inc.
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02265731     History of Changes
Other Study ID Numbers: M13-834
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: 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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
relapsed multiple myeloma
refractory multiple myeloma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphatic Diseases
relapsed chronic lymphocytic leukemia
small lymphocytic lymphoma
relapsed small lymphocytic lymphoma
refractory small lymphocytic lymphoma
refractory chronic lymphocytic leukemia
acute myeloid leukemia
Additional relevant MeSH terms:
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Venetoclax
Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myeloid, Acute
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents