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Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00606645
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
Xencor, Inc.

Brief Summary:
An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 was conducted to define the MTD or recommended dose(s) for further study, to determine safety and tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior therapeutic regimens. There will be no intra-patient dose escalation.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Anaplastic Large Cell Lymphoma Biological: XmAb2513 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Every Other Week XmAb®2513 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
Study Start Date : December 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: 1
Biological: XmAb2513
Intravenous infusion of XmAb2513 administered at a dose of 0.3, 1.0, 3.0, 6.0, 9.0, or 12 mg/kg in sequential dose cohorts.

Primary Outcome Measures :
  1. Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 1 year ]
  2. Assessment of immunogenicity [ Time Frame: 1 year ]
  3. Objective response rate, disease control rate, and progression free survival. [ Time Frame: 1 year ]
  4. Change in solCD30 [ Time Frame: 1 year ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosed with HL or ALCL.
  • Patients must have received two or more prior therapeutic regimens, one of which should include hematopoietic cell transplant, either autologous or allogeneic transplant.
  • If a hematopoietic cell transplant was refused, or the patient was not eligible to receive a transplant, the patient is still eligible to participate in the trial if the patient has received two or more prior chemotherapy based regimens.
  • Patients who have received allogeneic transplant must not have relapsed less than 6 months after their transplant and they must be at least 200 days post-transplant prior to enrollment, and with no evidence of GVHD
  • Patients should have at least one radiographically measurable site of disease of 1.5 cm in the largest dimension.
  • Patients must have completed all anti-cancer treatment > 4 weeks prior to enrollment.
  • Patients must have completed any palliative corticosteroid therapy (e.g. for management of Type B symptoms) > 2 weeks prior to enrollment.
  • Patients must be 18 years of age.
  • Required baseline laboratory data:

    • Platelet count 80,000/mm3 (patients must not be platelet transfusion-dependent as evidenced by maintenance of platelet count above 50,000/mm3 in the 28 days prior to enrollment without transfusion)
    • Absolute neutrophil count > 1,500/mm3
    • Creatinine ≤ 1.5 times ULN
    • ALT (SGPT) /AST (SGOT) ≤ 2.5 times upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 times ULN
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

  • Patients with known HL or ALCL involvement of either the leptomeningeal or central nervous system.
  • Patients requiring treatment with oral or intravenous corticosteroids or other oral or intravenous immunosuppressive agents.
  • Patients that have been designated Class III or IV by the New York Heart Association criteria.
  • Patients with a history of myocardial infarction or stroke within the last 6 months.
  • Patients with active infection are not eligible. This includes patients requiring anti-infective treatment during the 4 week period prior to enrollment. Patients on prophylactic anti-infective agents will be eligible provided they have no signs of active infection.
  • Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
  • Patients with a history of prior malignancy other than HL or ALCL that have not been in remission for greater than 5 years, with the exception of basal or squamous skin carcinoma, cervical carcinoma in situ on biopsy, or localized prostate cancer (Gleason score < 5).
  • Patients who are pregnant or breastfeeding.
  • Patients with major surgery or radiation therapy within four weeks prior to enrollment.

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): NCT00606645

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Xencor, Inc.
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Principal Investigator: Anas Younes, MD M.D. Anderson Cancer Center
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT00606645    
Other Study ID Numbers: XmAb2513-01
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell