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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xencor, Inc.
ClinicalTrials.gov Identifier:
NCT00606645
First received: January 21, 2008
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Hodgkin Lymphoma
Anaplastic Large Cell Lymphoma
Biological: XmAb2513
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Xencor, Inc.:

Primary Outcome Measures:
  • Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Assessment of immunogenicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Objective response rate, disease control rate, and progression free survival. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Change in solCD30 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: December 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
XmAb2513
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606645

Locations
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.
Investigators
Principal Investigator: Anas Younes, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT00606645     History of Changes
Other Study ID Numbers: XmAb2513-01
Study First Received: January 21, 2008
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, T-Cell
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 20, 2014