Trial Search Results

Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. ABT-199 is a pill that blocks BCL-2, a protein that is important for the survival of WM cells. Laboratory studies and early clinical data have shown that the investigational new agent, ABT-199, may kill cancer cells and may cause tumors to shrink. The purpose of this research study is to evaluate how well the study drug works and the safety of ABT-199 as a single agent in participants with WM that has come back or has shown no response to previous treatment.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborator: AbbVie

Stanford Investigator(s):

Intervention(s):

  • Drug: ABT199

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia and meeting criteria
   for treatment using consensus panel criteria from the Second International Workshop on
   Waldenstrom's macroglobulinemia (Owen 2003; Kyle 2003).

   - Measurable disease, defined as presence of serum immunoglobulin M (IgM) with a minimum
   IgM level of > 2 times the upper limit of normal of each institution is required.

   - Have received at least one prior therapy for WM.

   - Age ≥ 18 years.

   - ECOG performance status <2 (see Appendix A).

   - Participants must have normal organ and marrow function (growth factors cannot be
   given prophylactically to establish eligibility) as defined below:

      - Absolute neutrophil count > 1,000/mm3

      - Platelets > 50,000/mm3

      - Hemoglobin > 8 g/dL

      - Total bilirubin ≤ 1.5 mg/dL or < 2 mg/dL if attributable to hepatic infiltration
      by neoplastic disease

      - AST (SGOT) and ALT (SGPT) < 2.5X the institutional upper limit of normal

      - Creatinine clearance ≥50 ml/min

   - Not on any active therapy for other malignancies with the exception of topical
   therapies for basal cell or squamous cell cancers of the skin.

   - Females of childbearing potential (FCBP) must agree to use two reliable forms of
   contraception simultaneously or have or will have complete abstinence from
   heterosexual intercourse during the following time periods related to this study: 1)
   while participating in the study; and 2) for at least 28 days after discontinuation
   from the study. Men must agree to use a latex condom during sexual contact with a FCBP
   even if they have had a successful vasectomy. FCBP must be referred to a qualified
   provider of contraceptive methods if needed.

   - Able to adhere to the study visit schedule and other protocol requirements.

   - Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

   - Any serious medical condition, laboratory abnormality, uncontrolled intercurrent
   illness, or psychiatric illness/social condition that would prevent the participant
   from signing the informed consent form.

   - Concurrent use of any other anti-cancer agents or treatments or any other study
   agents.

   - Prior exposure to ABT-199 or BCL2 inhibitors.

   - Prior or ongoing clinically significant illness, medical condition, surgical history,
   physical finding, ECG finding, or laboratory abnormality that, in the investigator's
   opinion, could affect the safety of the patient, including symptomatic hyperviscosity;
   alter the absorption, distribution, metabolism or excretion of ABT-199; or impair the
   assessment of study results.

   - Grade > 2 toxicity (other than alopecia) continuing from prior anti-cancer therapy.

   - Known CNS lymphoma.

   - Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
   congestive heart failure, or myocardial infarction within 6 months of screening.

   - New York Heart Association classification III or IV heart failure.

   - Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
   resection of the stomach or small bowel, ulcerative colitis, symptomatic inflammatory
   bowel disease, or partial or complete bowel obstruction.

   - Known history of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or
   Hepatitis C Virus (HCV) infection.

   - Lactating or pregnant women.

   - Inability to swallow tablets.

   - History of non-compliance to medical regimens.

   - Unwilling or unable to comply with the protocol.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting