NCT01263899

Brief Summary

This is a Phase 2 study to assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

December 16, 2010

Last Update Submit

April 19, 2012

Conditions

Hodgkin LymphomaMantle Cell LymphomaIndolent Lymphoma

Keywords

Lymphoid malignanciesHodgkin lymphomaMantle Cell LymphomaIndolent LymphomaSB1518

Outcome Measures

Primary Outcomes (1)

  • Assess overall tumor response of SB1518 by CT/FDG-PET scan and bone marrow biopsy as applicable as a measure of efficacy

    Outcome Measure - To assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphophasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).

    Every even numbered cycle from baseline to 30 days after the last dose of study medication

Secondary Outcomes (2)

  • Assess durability of response

    Every even numbered cycle from baseline to 30 days after the last dose of study medication

  • Assess number of patients with adverse events as a measure of safety and tolerability

    Every even numbered cycle from baseline to 30 days after the last dose of study medication

Study Arms (1)

SB1518

EXPERIMENTAL
Drug: SB1518

Interventions

SB1518DRUG

SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.

SB1518

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically documented diagnosis of one of the following lymphoid malignancies:
  • Hodgkin Lymphoma;
  • Mantle Cell Lymphoma;
  • Indolent Lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma);
  • Patients must have received at least one prior treatment regimen; patients with Hodgkin Lymphoma must have received an autologous stem cell transplant, refused or been deemed ineligible for stem cell transplant;
  • Able to understand and willing to sign the informed consent form.

You may not qualify if:

  • Any histology other than Hodgkin Lymphoma, Mantle Cell Lymphoma or Indolent Lymphoma;
  • History of or active Central Nervous System (CNS) malignancy;
  • Active graft-versus-host disease (GVHD);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Weill Medical College of Cornell

New York, New York, 10021, United States

Location

University of Rochester James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

MD Anderson Cancer Canter

Houston, Texas, 77030, United States

Location

University of British Columbia

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Mantle-Cell

Interventions

11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Study Officials

  • Anas Younes, MD

    MD Anderson Cancer Center at University of Texas, Houston

    PRINCIPAL INVESTIGATOR

  • Jonathan Friedberg, MD

    University of Rochester James P. Wilmot Cancer Center

    PRINCIPAL INVESTIGATOR

  • Peter Martin, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Julie Vose, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

  • Richard Klasa, MD

    British Columbia Cancer Center - Vancouver Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2010

First Posted

December 21, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 20, 2012

Record last verified: 2012-04

Locations

CA(1)US(4)