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

NCT00606645 | Completed Phase 1

• 1 other identifier: XmAb2513-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

Hodgkin Lymphoma; Anaplastic Large Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies.

  1 year

Secondary Outcomes (4)

• Safety and tolerability

  1 year

• Assessment of immunogenicity

  1 year

• Objective response rate, disease control rate, and progression free survival.

  1 year

• Change in solCD30

  1 year

Study Arms (1)

1

EXPERIMENTAL

XmAb2513

Biological: XmAb2513

Interventions

XmAb2513 BIOLOGICAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (4)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic

Interventions

XMAB-2513

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Study Officials

• Anas Younes, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 4, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (4)