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A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Phase 1
18 Years
Not Enrolling
Lymphoma, Malignant, Hodgkin's Lymphoma, B Cell Lymphoma

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Trial Information

A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Inclusion Criteria:

- Subjects with histologically documented diagnosis of a lymphoid malignancy as defined
in the World Health Organization (WHO) classification scheme except for those listed
in Exclusion Criteria

- Subject must have received at least 2 prior regimens for their lymphoid malignancy,
one of which was an anthracycline-containing combination regimen and have shown
disease relapse or did not respond to the prior regimen

- Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused
or are ineligible to receive stem cell transplant

- Subjects must have measurable lesions (at least one target lesion measuring 2cm in
diameter) by computerized tomography (CT) scan

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- All men of reproductive potential and women of child-bearing potential must agree to
practice effective contraception during the entire study period and for one month
after the last study treatment unless documentation of infertility exists.
Additionally, women of child-bearing potential must have a negative pregnancy test
within 14 days prior to the first dose of study drug

- Able to understand and willing to sign the informed consent form

Exclusion Criteria:

- Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like
lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated

- History of or active Central Nervous System (CNS) malignancy

- Have undergone allogeneic stem cell transplant and were treated with
immunosuppressing agent within the past 6 months

- Active Graft-versus-host disease (GVHD)

- Uncontrolled inter-current illness including, but not limited to, ongoing active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements as judged by treating physician. Subjects receiving antibiotics
for infections that are under control may be included in the study

- Concurrent malignancy, except those subjects with early stage squamous cell carcinoma
of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
are eligible for the study

- Known HIV-positive (such subjects are at increased risk of lethal infections when
treated with potentially marrow-suppressive therapy)

- Known active Hepatitis A, B or C

- Women who are pregnant or lactating

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies.

Outcome Time Frame:

Throughout the study

Safety Issue:


Principal Investigator

Anas Younes, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

October 2011

Related Keywords:

  • Lymphoma, Malignant
  • Hodgkin's Lymphoma
  • B Cell Lymphoma
  • Lymphoid malignancies
  • Hodgkin's Lymphoma
  • Diffuse large B cell lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, B-Cell



MD Anderson Cancer Center Houston, Texas  77030-4096