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Trial record 1 of 1 for:    NCT02924402
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Study to Evaluate Safety and Tolerability of XmAb13676 in Patients With CD20-expressing Hematologic Malignancies

This study is currently recruiting participants.
Verified December 2017 by Xencor, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02924402
First Posted: October 5, 2016
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Chiltern International Inc.
Information provided by (Responsible Party):
Xencor, Inc.
  Purpose
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD after second and subsequent infusions.

Condition Intervention Phase
B-cell Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Biological: XmAb13676 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will enroll two parallel disease groups: patients with non-CLL B cell malignancies and patients with CLL/SLL/Ricter's Transformation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb13676 in Patients With CD20-Expressing Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Xencor, Inc.:

Primary Outcome Measures:
  • Safety as determined by the number of participants with treatment-related adverse events [ Time Frame: Baseline Day 1 through Day 56 ]
    treatment-related adverse events as assessed by CTCAE v4.03

  • Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing [ Time Frame: Baseline Day 1 through Day 56 ]
    Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing


Estimated Enrollment: 66
Actual Study Start Date: October 2016
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-CLL B Cell Malignancies (Group NHL)
XmAb13676 administered IV weekly up to 8 weeks
Biological: XmAb13676
Biological
Experimental: CLL/SLL (Group CLL)
XmAb13676 administered IV weekly up to 8 weeks
Biological: XmAb13676
Biological

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide written informed consent
  • Diagnosis of either Non-CLL B cell malignancy or CLL/SLL
  • Ineligible for or have exhausted standard therapeutic options
  • Last dose of anti-CD20 antibody therapy must have been >4 weeks before the first dose of XmAb13676
  • ECOG performance status 0-2
  • Not a candidate for or refusing treatment with hematopoietic stem cell transplantation
  • Fertile patients must agree to use effective contraception during and for 4 weeks after completion of study
  • Able and willing to complete the entire study

Exclusion Criteria:

  • Cytotoxic chemotherapy, radiotherapy, or immunotherapy within 4 weeks, or small molecule or investigational agents within 6 elimination half-lives of the first dose of XmAb13676
  • Prior allogeneic stem cell or solid organ transplantation
  • Failure to recover from Grade 3 or 4 toxicity from previous treatment
  • Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
  • Known intolerance to CD20 monoclonal antibody therapy
  • History of primary central nervous system lymphoma or neoplastic central nervous system disease
  • Platelet count < 50 x 10^9/L
  • Absolute neutrophil count < 1.0 x 10^9/L
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at screening > 3x upper limit of normal (ULN)
  • Bilirubin > 1.5 mg/dL
  • Estimated creatinine clearance < 50 mL/min
  • Active/uncontrolled autoimmune disease
  • Clinically significant cardiac/cardiovascular disease, or pulmonary compromise
  • Seizure disorder
  • History of stroke with the past year
  • History or evidence of a clinically unstable/uncontrollable disorder, condition or disease other than primary malignancy, that in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
  • Evidence of any serious bacterial, viral, parasitic or systemic fungal infections within the 30 days prior to study entry
  • Positive test for human immunodeficiency virus (HIV) or hepatitis C (HCV) antibodies (unless HCV viral load test by PCR is negative)
  • Positive test for HbsAg, or positive test for HBcAb (unless serology is positive due to recent intravenous immunoglobulin therapy). HBcAb positivity will be allowed if HBsAb is present.
  • Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the End of Study visit
  Contacts and Locations
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): NCT02924402


Contacts
Contact: Wayne Saville, MD 858-480-3410 wsaville@xencor.com
Contact: Chelsea Johnson, RN 858-480-3891 cjohnson@xencor.com

Locations
United States, California
Moores UC San Diego Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Mark Buss    858-822-7916    mabuss@ucsd.edu   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Reem Karmali, MD    312-695-0990      
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: William Wierda, MD       wwierda@mdanderson.org   
Contact: Jeanne Lichty, RN    713-794-4683    jmlichty@mdanderson.org   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Krish Patel, MD    206-215-2338    krish.patel@swedish.org   
Contact: Tenzin Tsomo    206-386-2831    Tenzin.Tsomo@swedish.org   
Sponsors and Collaborators
Xencor, Inc.
Chiltern International Inc.
Investigators
Study Director: Wayne Saville, MD VP, Oncology Clinical Development, Xencor, Inc.
  More Information

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT02924402     History of Changes
Other Study ID Numbers: XmAb13676-01
First Submitted: September 14, 2016
First Posted: October 5, 2016
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xencor, Inc.:
NHL
B-cell Prolymphocytic Leukemia
Transformed Lymphoma
Burkitt's Lymphoma
Mantle Cell Lymphoma
Hairy Cell Leukemia
Splenic Marginal Zone Lymphoma
Waldenstrom's Macroglobulinemia
Variant Hairy Cell Leukemia
Splenic B-cell Lymphoma/Leukemia
Lymphoplasmacytic Lymphoma
Extranodal Marginal Zone Lymphoma (MALT)
MALT Lymphoma
Nodal Marginal Zone Lymphoma
Follicular Lymphoma
In Situ Follicular Neoplasia
Duodenal-type Follicular Lymphoma
Large B-cell Lymphoma with IRF4 rearrangement
Primary Cutaneous Follicle Center Lymphoma
Diffuse Large B-cell Lymphoma
DLBCL
T-cell/Histiocyte-Rich Large B-cell Lymphoma
Primary Cutaneous DLBCL, leg type
EBV-positive DLBCL, NOS
EBV-positive Mucocutaneous Ulcer
DLBCL Associated with Chronic Inflammation
Lymphomatoid Granulomatosis
Primary Mediastinal (Thymic) Large B-cell Lymphoma
Intravascular Large B-cell Lymphoma
ALK+ Large B-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell