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

This study has been completed.
Sponsor:
Information provided by:
Xencor, Inc.
ClinicalTrials.gov Identifier:
NCT00606645
First received: January 21, 2008
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 will be 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: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 48
Study Start Date: December 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: XmAb2513
XmAb2513 is An anti-CD30 antibody that will be given at doses of 0.3, 1.0, 3.0, 6.0, 9.0 or 12.0 mg/kg

  Show Detailed Description

  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 provide tumor tissue for confirmation of histologic diagnosis and presence of CD30 in the tumor tissue. Archived paraffin embedded samples are acceptable for patients who have no prior exposure to another anti-CD30 therapy and samples should be provided from the most recent biopsy and if possible from the original biopsy as well. Patients who have previously received anti-CD30 regimens must also have a biopsy performed and assessed for CD30 expression prior to study enrollment to confirm the presence of CD30 in the tumor tissue. The biopsy may be performed during the screening period or may have been performed after progression from the last anti-tumor therapy was completed.
  • 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. Additionally, there must be no evidence of GVHD and the patient must be stable without immunosuppressive treatment, including systemic corticosteroids (per os [po] or iv), for > 3 months prior to enrollment.
  • Patients who have previously received any targeted anti-CD30 therapies are eligible provided that the therapy was completed at least 6 months prior to enrollment, there is no residual toxicity, and there is evidence of CD30 positivity on recent or new biopsy. Additionally, these patients must be negative for anti-XmAb2513 antibodies.
  • 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 who have received a hematopoietic cell transplant must have completed immunosuppressive treatment, including systemic corticosteroids for > 3 months 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 have received two or more prior therapeutic regimens, one of which should include hematopoietic cell transplant, either autologous or allogeneic transplant.
  • 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 receiving treatment with an investigational agent, concurrently or within 28 days prior to dosing in this study.
  • Patients with known HL or ALCL involvement of either the leptomeningeal or central nervous system.
  • Patients who received prior anti-CD30 therapy AND with anti-XmAb2513 antibodies in serum detected by the Xencor screening assay.
  • 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 known hypersensitivity to any excipient contained in the drug formulation.
  • 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
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: Rolondo Enoch, Xencor
ClinicalTrials.gov Identifier: NCT00606645     History of Changes
Other Study ID Numbers: XmAb2513-01
Study First Received: January 21, 2008
Last Updated: February 2, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014