Trial Search Results

Safety Study of ABT-263 in Combination With Rituximab in Lymphoid Cancers

This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with rituximab in subjects with CD20-positive lymphoproliferative disorders. The extension portion of the study will allow active subjects to continue to receive ABT-263 for up to 7 years after the last subject transitions with quarterly study evaluations.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AbbVie (prior sponsor, Abbott)

Collaborator: Genentech, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: rituximab
  • Drug: ABT-263

Phase:

Phase 1

Eligibility


Inclusion Criteria:

   - Diagnosed with a CD20-positive lymphoproliferative disorder (REAL/WHO) and
   bi-dimensionally measurable disease with at least 1 lesion > or = 1.0 cm

   - ECOG performance score of
   - Adequate bone marrow function, independent of growth factor support (with the
   exception of subjects with bone marrow that is heavily infiltrated with underlying
   disease [80% or more] who may use growth factor to achieve ANC eligibility criteria)
   per local laboratory reference range as follows: Absolute Neutrophil count (ANC) ≥
   1000/μL; Platelets ≥ 100,000/mm3 (untransfused); Hemoglobin ≥ 9.0 g/dL.

   - Subjects who have a history of autologous stem cell transplant (e.g., bone marrow)
   must be > 6 months post transplant and have adequate bone marrow function, independent
   of any growth stimulating factors (with the exception of subjects with bone marrow
   that is heavily infiltrated with underlying disease [80% or more] who may use growth
   factor to achieve ANC eligibility criteria) per local laboratory reference range as
   follows: Absolute Neutrophil count (ANC) ≥ 1500/μL; Platelets ≥ 125,000/mm3
   (untransfused); Hemoglobin ≥ 10.0 g/dL.

   - Subject must have adequate renal, hepatic and coagulation function per local
   laboratory reference range as follows: Serum creatinine ≤ 2.0 mg/dL or calculated
   creatinine clearance ≥ 50 mL/min; AST and ALT ≤ 3.0 × the upper normal limit (ULN);
   Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's Syndrome may have a Bilirubin > 1.5 ×
   ULN; aPTT, PT not to exceed 1.2 × ULN

   - Females must be surgically sterile, postmenopausal (at least 1 year), or have negative
   pregnancy test at screening on serum sample and prior to first dose of study drug on
   urine sample. Females not surgically sterile or postmenopausal (at least 1 year) and
   non-vasectomized males must practice at least 1 of the following:total abstinence from
   sexual intercourse (min.1 complete menstrual cycle),a vasectomized partner, hormonal
   contraceptives for at least 3 months prior to study drug administration, or
   double-barrier method.

Inclusion Criteria (Extension Study):

   - Subjects who enter the Extension Study must continue to meet all Inclusion and
   Exclusion criteria, with the exception of inclusion criteria regarding measurable
   disease and inclusion criteria regarding laboratory parameters. Subjects entering the
   Extension Study must also have stable lab values per local laboratory reference
   ranges. In addition they must meet the following lab criteria:

   - Subjects must meet the following hematology and coagulation lab criteria:

      - Platelet counts must be ≥ 25,000/mm3 (untransfused). Platelet counts ≤ 50,000/mm3
      must be stable and monitored at an increased frequency at the discretion of the
      investigator.

      - Absolute Neutrophil count (ANC) ≥ 500/μL. ANC ≥ 500/μL and < 1,000/μL should be
      monitored at an increased frequency at the discretion of the investigator.

      - Hemoglobin of ≥ 8.0 g/dL.

      - aPTT, PT is not to exceed 1.2 × ULN.

   - Subjects' chemistry values must not exceed Grade 2. Grade 2 chemistry labs should be
   monitored at an increased frequency at the discretion of the investigator. Subjects
   must meet the following chemistry criteria:

      - Serum creatinine ≤ 3.0 × the upper normal limit (ULN) of institution's normal
      range.

      - AST and ALT ≤ 5.0 × the upper normal limit (ULN) of institution's normal range.

      - Bilirubin ≤ 3 × ULN. Subjects with Gilbert's Syndrome may be allowed to have a
      Bilirubin > 3 × ULN based on a joint decision between the investigator and Abbott
      medical monitor.

Exclusion Criteria:

   - History of or clinically suspicious for cancer-related Central Nervous System (CNS)
   disease, allogeneic stem cell transplant, recurrent significant infections, previous
   or current malignancies within the last 5 years ( except: adequately treated in situ
   carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ
   carcinoma of the bladder; previous malignancy confined and surgically resected with
   curative intent), toxicity from rituximab that resulted in permanent discontinuation
   of treatment or toxicity from ABT-263 or another Bcl-2 family protein inhibitor,
   significant cardiovascular disease (e.g., MI within 6 months), renal, neurologic,
   psychiatric, endocrinologic, metabolic, immunologic or hepatic disease that would
   adversely affect participation, severe (defined as Grade 4 and/or requiring permanent
   discontinuation of prior antibody therapy) allergic or anaphylactic reactions to
   human, humanized, chimeric or murine monoclonal antibodies

   - The subject has an underlying, predisposing condition of bleeding or currently
   exhibits signs of clinically significant bleeding. The subject has a recent history of
   non-chemotherapy induced thrombocytopenic associated bleeding within six months prior
   to the first dose of study drug. The subject has active peptic ulcer disease or other
   hemorrhagic esophagitis/gastritis or active immune thrombocytopenic purpura (ITP) or a
   history of being refractory to platelet transfusions (within six months prior to the
   first dose of study drug).

   - Female subject is pregnant or breast-feeding

   - Subject has tested positive for HIV, Hepatitis B or Hepatitis C infection, (Subjects
   who test positive for anti-HBc (carrier) will be allowed to enroll)

   - Evidence of other clinically significant uncontrolled condition(s) including, but not
   limited to: active systemic fungal infection; diagnosis of fever and neutropenia
   within one week prior to study drug administration

   - Received steroid therapy for anti-neoplastic intent within seven days prior to the
   first dose of study drug,received aspirin within seven days prior to the first dose of
   study drug, CYP3A inhibitors (e.g., ketoconazole, clarithromycin) within 7 days prior
   to the administration of the first dose of study drug, radio-immunotherapy within six
   months prior to first dose of study drug,received any anti-cancer therapy within
   fourteen days prior to the first dose of study drug.

Ages Eligible for Study

18 Years - 99 Years

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
Cancer Clinical Trials Office
650-498-7061
Not Recruiting