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Lymphoma and Multiple Myeloma

Waldenstrom's Macroglobulinemia (WM)

1

Disease Status and/or Stage Waldenstrom’s macroglobulinemia
Protocol Title A Phase II Trial of Ofatumumab in Subjects with Waldenstrom’s Macroglobulinemia
PI Richard Furman, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility Diagnosis of Waldenstrom’s macroglobulinemia requiring therapy.
Treatment Overview On week 1, the study drug will be administered at a dose of 300 mg IV. For weeks 2-4, all subjects will receive a dose of 1000 mg IV. Patients that respond to ofatumumab but later relapse or progress while on the study may receive re-treatment with ofatumumab (300 mg IV first week, 1000 mg IV second to fourth week). Patients may only be re-treated with ofatumumab once. Patients will be followed (weekly through week 8, monthly through week 52, and then every three months thereafter) until disease progression.

2

Disease Status and/or Stage Recurrent Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
Protocol Title Phase I trial of anti-CD74 (hLL1) antibody therapy in B cell malignancies
PI John Leonard, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility Patients must have histologically confirmed diagnosis of recurrent B cell non-Hodgkin’s lymphoma or recurrent chronic lymphocytic leukemia. Patients must have received at least one prior treatment with standard
chemotherapy and at least one prior treatment with rituximab. Tumor tissue required for correlative analyses.
Treatment Overview

hLL1 (humanized anti-CD74 monoclonal antibody) administered intravenously daily, five days
per week (Monday to Friday), for two weeks at one of 4 planned dose levels. Treatment occurs over 2 weeks
with post-treatment evaluations over 12 weeks. Follow-up is required in all patients until resolution of any treatment related abnormalities or until relapse occurs.

3

Disease Status and/or Stage Relapsed or Refractory Hematologic Malignancies
Protocol Title A Phase 1 Sequential Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of CAL-101 in Patients with Select, Relapsed or Refractory Hematologic Malignancies
PI Richard Furman , MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

CLL patients who are refractory to or relapsed after at least 2 prior therapies, including fludarabine, alone or in combination.

Patients must be symptomatic.
Treatment Overview

The study drug should be taken twice a day. The patient should take the morning dose with water on an empty stomach; food can be consumed at least an hour after dosing. The evening dose should be taken with water approximately 12 hours after the morning dose and at least 2 hours after a
meal.

Each patient will be assessed for clinical response after completing 1 cycle of 28 days of treatment. Treatment may continue for up to a total of 6 cycles.

4

Disease Status and/or Stage Relapsed or Refractory Disease
Protocol Title A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects with Relapsed or Refractory Lymphoid Malignancies
PI Richard Furman, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility Any relapsed or refractory lymphoma, excluding Burkett's lymphoma and patients who had a stem cell transplant.
Treatment Overview Participants will self-administer ABT-263 by mouth once daily (QD). Each dose will be taken with approximately 240 mL of water. In Phase 1, all subjects will receive ABT-263 under fasting conditions on Cycle 1 Day -3 through Cycle 1 Day 1. On all other dosing days of Phase 1, the subjects will receive ABT-263 at approximately 30 minutes after breakfast. In Phase 2a, all subjects will self-administer ABT-263 at approximately 30 minutes after breakfast. The effect of food on pharmacokinetics will be evaluated and changes will be initiated if fasting conditions are superior.

5

Disease Status and/or Stage Relapsed or Refractory Hematologic Malignancies
Protocol Title A Phase I Dose Escalation Study of SGN-35 in Patients with Relapsed/refractory CD30 Positive Hematologic Malignancies
PI John Leonard, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

Adult subjects with histologically confirmed CD30-positive hematologic malignancy and have failed systemic chemotherapy as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy and refused or were ineligible for stem cell transplant.
Treatment Overview

SGN-35 will be administered on Day 1 of each 21 day cycle via a 2-hour intravenous infusion according to the dose level assigned to each cohort.

6

Disease Status and/or Stage Relapsed or Refractory Non-Hodgkin's Lymphoma
Protocol Title A Phase I-II Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Cycle in Patients with Non-Hodgkin’s Lymphoma
PI John Leonard, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility Patients with indolent NHL who have relapsed or are refractory to at least one prior therapy; patients with aggressive NHL who are refractory to at least one line of therapy.
Treatment Overview Patients will be infused with SB-743921 on Days 1 and 15 of a 28-Day cycle and continue treatment until disease progression.

7

Disease Status and/or Stage Any Stage of Cancer
Protocol Title Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism (VTE) in Patients with Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

VTE Treatment Group: Eligible subjects must be age 18 years or older, diagnosed with active cancer and have a documented first venous thromboembolic event. Subjects must be currently receiving any treatment for cancer. In addition, subjects must have a documented first venous thromboembolic event (VTE). Subjects must not be in need of long-term anticoagulant therapy or be undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia or has other conditions associated with persistent thrombocytopenia of less than 100x109/L for a duration of at least four consecutive weeks.

Control Group Patients: Eligible control patients will be matched patients aged 18 years or older and diagnosed with active cancer meeting the same criteria as above but without thrombosis
Treatment Overview

All eligible subjects with VTE will receive tinzaparin 175 U/kg/day for at least 6 months with another 6 months at the investigator's discretion (up to one year study treatment). Plasma markers of hemostasis, fibrolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months after start of tinzaparin treatment (if subject agrees).

Patients with cancer but without blood clots (control group) will also be enrolled in this study but will not receive study drug. For these patients, information regarding overall heath and response to their cancer treatment will be monitored. Plasma markers of hemostasis, fibrinolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months (if subject agrees)
  Last updated: July 30, 2008
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