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HEMATOLOGY

Hodgkin's Lymphoma

Phase I, Open-label, Dose-escalation, Multi-dose Study of an Anti-CD30 Antibody Administered Weekly for 4 Weeks in Patients with CD30-positive Refractory/relapsed Hodgkin's Lymphoma.

On this trial, patients older than 12 years old who have CD30-positive (by IHC or Flow Cytometry) relapsed/refractory Hodgkin's Lymphoma with measurable disease and good performance status will receive treatment with a high affinity, fully human anti-CD30 antibody weekly for 4 doses. They will be eligible for retreatment if they achieve stable disease or if they progress following an initial CR/PR.
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Non-Hodgkin's Lymphoma

A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Lenalidomide (Revlimid®) In Combination With Dexamethasone In Subjects With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma.

Summary of the Eligibility Criteria:

Key Inclusion Criteria:

  1. Diffuse large B-cell non-Hodgkin's lymphoma relapsed or refractory to previous therapy including autologous stem cell transplant. There is no limit on the number of prior therapies.
  2. Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
  3. ECOG performance status score of 0, 1, or 2.
  4. Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.

Key Exclusion Criteria:

  1. Any of the following laboratory abnormalities.
    • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L)
    • Platelet count < 60,000/mm3 (60 x 109/L)
    • Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN)
    • Serum total bilirubin > 2.0 mg/dL (34 µmol/L)
  2. Subjects with a calculated creatinine clearance (Cockcroft-Gault formula) of <50mL/min not receiving dialysis.
  3. All subjects with active central nervous system (CNS) lymphoma. Subjects with previous CNS lymphoma that have been treated with chemotherapy, radiotherapy or surgery who have remained asymptomatic for 90 days (3 months) and demonstrate no CNS disease as shown by lumbar puncture, CT or MRI are eligible. (If required, a lumbar puncture, CT or MRI should be performed during screening process.) Subjects should not be receiving corticosteroids.
  4. Subjects not willing or unable to take DVT prophylaxis.
  5. Pregnant or lactating females.

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Chronic Lymphoproliferative Disease

Summary of Eligibility Criteria

A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly Administration of GRN163L in Patients with Chronic Lymphoproliferative Disease

Key Inclusion Criteria:

  1. Patients with Chronic lymphoproliferative disease with related biology or similar clinical pattern to B-Cell Leukemia (CLL) ; including: Small lymphocytic lymphoma (SLL);T cell prolymophocytic leukemia (T-PLL); B cell prolymphocytic leukemia (B-PLL); Mantle cell lymphoma or other non-Hodgkins lymphoma in leukemic phase (peripheral blood circulating malignant cells present); Waldenstrom's macroglobulinemia. Patients with other uncommon lymphoproliferative conditions may be eligible following discussion with the study monitor. Patients with multiple myeloma will not be eligible.
  2. Patients must have relapsed from or be refractory to prior therapeutic regimens. Patients with CLL or SLL - must have received at least one prior purine analogue-based chemotherapy regimen (eg, fludarabine, pentostatin or cladribine)
  3. Performance Status (ECOG) 0-2

Key Exclusion Criteria:

  1. Patients with evidence of an active or ongoing autoimmune disorder (eg, autoimmune hemolytic anemia [AHA], autoimmune thrombocytopenic purpura [ITP], pure red cell aplasia, etc.).
  2. Patients with CNS (or leptomeningeal) involvement by their disease.
  3. Patients with any of the following serum chemistry abnormalities: Total bilirubin > 1.5×ULN; AST or ALT > 2.5×ULN (> 5× if due to hepatic leukemic or lymphomatous disease involvement); Serum albumin < 2.5 g/dL; Creatinine > 1.5 × ULN (or a calculated creatinine clearance < 50 mL/min/1.73 m2**)
  4. Patients with a clinically significant cardiovascular disease or condition,
  5. Patients with a platelet count < 50,000 per mm3
  6. Active, uncontrolled bleeding; bleeding diathesis; PT or PTT > ULN
  7. Pregnant or lactating women