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Lymphoma and Multiple Myeloma

Chronic Lymphocytic Leukemia (CLL) / Small Lymphocitic Lymphoma (SLL)

1

Disease Status and/or Stage Refractory or Relapsed CLL
Protocol Title A Phase I/II, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of Weekly Administration of GRN163L in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia
PI Richard Furman, MD
Contact

Patricia Glynn, RN
212-746-6738

Key Eligibility Patients with documented CLL who require treatment due to active disease that is relapsed from, or refractory to prior treatment, at least one containing fludarabine.
Treatment Overview

During the Phase I portion of study, patients will receive increasing doses of GRN163L depending upon when they enroll onto the study. Additional patients will continue to be treated at the Phase II dose.

GRN163L will be administered as a 6-hour IV infusion once a week for 4 weeks.

Patients who DO NOT experience any intolerable side effects may receive an additional 4-week cycle of GRN163L.

Patients who continue to respond to GRN163L after 8 weeks of treatment may continue to receive treatment for as long as the study doctor recommends provided that the patient continues to respond to GRN163L and does not experience any intolerable side effects.

GRN162L is a telomerase inhibitor.

2

Disease Status and/or Stage Refractory CLL
Protocol Title A Single-arm, International, Multi-Center Trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in Patients with B-Cell Chronic Lymphocytic Leukemia who have Failed Fludarabine and Alemtuzumab
PI Richard Furman, MD
Contact

Patricia Glynn, RN
212-746-6738

Key Eligibility CLL that is refractory to fludarabine based chemotherapy.
Treatment Overview

Each patient will receive 8 weekly infusions of HuMax-CD20, followed by 4 monthly infusions of HuMax-CD20.

HuMax-CD20 is a human monoclonal antibody directed against CD20.

3

Disease Status and/or Stage Relapsed or Refractory CLL/SLL
Protocol Title A Phase 1/2 Study of TRU-016 in Patients with Previously Treated Chronic Lymphocytic Leukemia
PI Richard Furman, MD
Contact

Patricia Glynn, RN
212-746-6738

Key Eligibility Patients with a diagnosis of CLL or SLL. Refractory or relapsed disease after treatment with at least one previous fludarabine-containing chemotherapy regimen.
Treatment Overview TRU-016 will be given to patients once a week for 4 doses. If a maximum tolerated dose is not observed while patients receive the once weekly dose, following patients will receive TRU-016 three times the first week followed by once a week for 3 weeks.

4

Disease Status and/or Stage Previously Treated CLL
Protocol Title A Phase Ib Pharmacokinetic-Pharmacodynamic-Pharmacogenomic Study of Enzastaurin in Patients with B-Cell Chronic Lymphocytic Leukemia (B-CLL)
PI Richard Furman, MD
Contact

Patricia Glynn, RN
212-746-6738

Key Eligibility CLL that has relapsed after prior therapy
Treatment Overview

Patients will receive Enzastaurin by mouth daily. Patients will be evaluated every 28 days and remain on study as long as they are responding.

5

Disease Status and/or Stage Previously untreated or relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia (CLL)
Protocol Title Phase I/II Study of Subcutaneously Administered Veltuzumab (hA20) in Patients with CD20+ Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
PI Rebecca Elstrom, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Histologically confirmed diagnosis of CD20+ follicular, small lymphocytic leukemia, or marginal zone Non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Cannot have received any prior treatment.
Treatment Overview Patients receive veltuzumab administered subcutaneously every other week for 4 injections. Patients are closely monitored during subcutaneous injections and then at intervals over a 12-week post-treatment evaluation period. Patients complete the study at their 12-week post-treatment evaluation. Limited follow-up evaluations will then continue every 3 months for 2 years.

6

Disease Status and/or Stage Untreated CLL
Protocol Title CALGB 10501: A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation with Later Treatment in the High Risk Genetic Subset with IgVH Unmutated Disease
PI Richard Furman, MD
Contact

Patricia Glynn, RN
212-746-6738

Key Eligibility Pre-Registration - Patients must be within 6 months of the initial flow cytometric confirmation of B-cell CLL. Patients must be in the low risk category of CLL, have no evidence of active disease, and have had no prior therapy for CLL

Registration - Successful determination of IgVH mutational status. Absence of progression of CLL.
Treatment Overview

Patients will be randomized into one of two study groups. Patients with high-risk CLL will be randomized (Arm A or B) in this way because it is not known whether either approach offers a benefit over the other. Patients with low-risk CLL, will be placed in Arm C.

Arm A ("Early Treatment") - Patients will begin treatment within one month of randomization. Patients will be given rituximab on days 1, 3, and 5 of week 1, and then on the first day during weeks 5, 9, 13, 17, and 21. There will be a total of eight doses of rituximab. Patients will also receive fludarabine by IV infusion. Fludarabine will be given each day for five days during weeks 1, 5, 9, 12, 17, and 21.

Arm B ("Observation with Later Treatment") - If patients are placed in Arm B, they will see their doctor every three months for physical exams and blood tests. When they begin to experience symptoms related to the disease, they will begin treatment. They will be given rituximab on days 1, 3, and 5 of week 1, and then on the first day during weeks 5, 9, 13, 17, and 21. They will also receive fludarabine by IV infusion. Fludarabine will be given over a period of 30 minutes each day for five days during weeks 1, 5, 9, 13, 17, and 21.

Arm C ("Low-Risk CLL") - If the patient's blood test reveals that they have "low-risk CLL", they will see their doctor every three months for physical exams and blood tests. When they begin to experience symptoms related to the disease, they will begin treatment.

7

Disease Status and/or Stage Untreated CLL
Protocol Title CALGB 10404: A Randomized Phase II Study of Three Fludarabine/Antibody Combinations for Patients with Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia (CLL)
PI Richard Furman, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Patients must have symptomatic and active intermediate or high-risk CLL. Patients must not have any prior therapy for CLL.
Treatment Overview Patients will be randomized into one of the study groups described below:

Group A - Patients will receive fludarabine and rituximab during induction therapy followed by observation.

Group B - Patients will receive Fludarabine and Rituximab during induction therapy followed by consolidation therapy with lenalidomide.

Group C - Patients will receive fludarabine, rituximab, and cyclophosphamide during induction therapy followed by observation.

8

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 Patricia Glynn, RN
212-746-6738
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.

9

Disease Status and/or Stage Relapsed/Refractory B-Cell CLL
Protocol Title A Phase I/II Multi-Center, Open-Label Study of the Safety and Efficacy of a Stepwise Dose-Escalation Schedule of Lenalidomide Monotherapy in Subjects with Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
PI Richard Furman, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Adults at least 18 years old who are relapsed or refractory to at least one fludarabine and alkylator containing regimen.
Treatment Overview Participants will receive 2.5 mg daily of Lenalidomide (Revlimid®) for the first cycle (28 days). Dose will be escalated in a step-wise fashion with each subsequent cycle.

10

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 Patricia Glynn, RN
212-746-6738
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.

11

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 22,, 2008
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