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Lymphoma and Multiple Myeloma

Non-Hodgkin's Lymphoma (NHL)

1

Disease Status and/or Stage Newly Diagnosed Follicular Non-Hodgkin's Lymphoma (NHL)
Protocol Title A Phase III Trial of CHOP + Rituximab vs. CHOP + Iodine 131-Labeled Monoclonal Anti-B1 Antibody (tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas
PI John Leonard, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Patients must have previously untreated Non-Hodgkin's Lymphoma (Grade 1, II, or III)

Patients must have bidimensional measurable diease
Treatment Overview Arm 1: 6 cycles of CHOP + 6 doses of concurrent rituximab. CHOP will be administered at 3 week intervals

Arm 2: CHOP followed by tositumomab and I-131 tositumomab

2

Disease Status and/or Stage Untreated CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) of any stage
Protocol Title Early Response Assessment in Patients with Diffuse Large B-Cell Lymphoma Using 18-fluoro-2-deoxyglucose positron emission tomography (FDG-PET)
PI Rebecca Elstrom, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Patients must have histologically or cytologically confirmed diagnosis of CD20+ diffuse large B-cell lymphoma (DLBCL) of any stage, including subtypes Mediastinal Large B-Cell, Centroblastic, Immunoblastic, T-cell Rich B-cell and Anaplastic B-cell Lymphoma. Patients must have a treatment plan to include R/CHOP or R/CHOP followed by radiotherapy and received no prior anti-lymphoma therapy.
Treatment Overview Patients will undergo 2 cycles of chemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and predisone (R/CHOP). 14 to 21 days following Cycle 2 of R/CHOP, patients will undergo repeat FDG-PET scan (PET-2). They will then complete therapy as planned. Following completion of therapy, standard response assessment will be performed, including CT scans of the chest, abdomen, and pelvis and FDG-PET scan (PET-3)

3

Disease Status and/or Stage Relapsed or Refractory T-Cell Lymphoma
Protocol Title A Phase II, Multicenter, Open-Label Trial Evaluating the Activity and Tolerability of Romidepsin (depsipeptide, FK228) in Progressive or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy.
PI Rebecca Elstrom, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Patients must have histologically confirmed peripheral T-cell lymphoma who have relapsed disease after autologous stem cell tranplant and progressive disease following at least one systemic therapy or refractory to at least one prior systemic therapy.
Treatment Overview Patients will receive Romidepsin 14 mg/m2 intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle. The planned duration of study treatment is 6 cycles or until disease progression occurs. Patients who respond may be treated beyond 6 cycles until progressive disease is documented or until a withdrawal criterion is met if both the Investigator and the patient agree. Patients who are responding but who do not elect to continue treatment will be followed until disease progression and/or a new therapy is instituted.

4

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.

5

Disease Status and/or Stage Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Protocol Title Phase II Trial of "VIPER" Chemotherapy in Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma (NHL)
PI Richard Furman, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Histologically confirmed diagnosis of CD20 positive, diffuse large B-cell NHL. Patient must have relapsed after or not responded to at least one standard, upfront
multi-agent chemotherapy for DLBCL. Patients who previosuly received bortezomib (Velcade) are not eligible.
Treatment Overview Treatment will be given approximately every 28-days for three cycles. Rituximab will be administered on Day 1 of each cycle prior to the start of the DICE chemotherapy. DICE will be administered on Days 1-4 of each cycle. Velcade will be administered on Days 2 and 5 of each cycle.

6

Disease Status and/or Stage Relapsed or Refractory Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma (Follicular, DLBCL, or Mantle Cell)
Protocol Title A Phase 2, Open-label Trial to Evaluate the Efficacy and Safety of MGCD0103 Administered in Combination With Azacitidine (Vidaza®) to Subjects With Relapsed or Refractory Hodgkin's or Non-Hodgkin's Lymphoma, and to Evaluate the Pharmacokinetics of Different Formulations of MGCD0103 (103 PH US 2007 CL002)
PI Rebecca Elstrom, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Histologically confirmed diagnosis of classical Hodgkin's lymphoma or NHL (follicular lymphoma, DLBCL, or MCL) and confirmed relapsed or refractory disease
Treatment Overview In Part I, all patients will receive two doses of MGCD0103 over a 2 week period and blood drawn for pharmacokinetic studies. In Part II, patients will receive azacitidine on days 1-5 of a 28 day cycle followed by MGCD0103 on days 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 of each 28-day cycle.

7

Disease Status and/or Stage Newly Diagnosed Mantle Cell Lymphoma
Protocol Title Phase II Trial of Bevacizumab plus CHOP-Rituximab in Patients with Previously Untreated Mantle Cell Non-Hodgkin's Lymphoma (NHL)
PI John Leonard, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Histologically confirmed diagnosis of mantle cell Non-Hodgkin’s Lymphoma with characteristic immunophenotypic profile: CD5(+), CD19(+) or CD20(+), cyclin D1(+), CD23(-) and CD10(-). Patients cannot have had any prior anti-cancer therapy for lymphoma
Treatment Overview

The purpose of this study is to evaluate the safety and efficacy of adding Bevacizumab to the established R-CHOP regimen in patients with newly diagnosed MCL.

R-CHOP is given on a 21-day cycle basis for a total of 6 cycles. Bevacizumab is administered on Day 1 of each cycle, while R-CHOP is administered on Day 3 of each cycle.

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 Mantle Cell Lymphoma
Protocol Title Phase II Trial of Anti-Angiogenic Therapy with RT-PEPC in Patients with Relapsed Mantle Cell Lymphoma
PI John Leonard, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility Patients with persistent / recurrent mantle cell Non-Hodgkin's Lymphoma
Treatment Overview

Induction Phase: Rituximab once weekly during Weeks 1 - 4; PEPC daily during Weeks 1 - 12

Maintenance Phase: Rituximab once weekly during Weeks 17 - 20 and 33 - 36; PEPC daily during Weeks 13 - 48

Post-Month 12 Maintenance Phase (until disease progression): Rituximab once weekly during Weeks 1 - 4; PEPC daily during Weeks 1 - 16

PEPC - Prednisone 20 mg/day, Cyclophosphamide 50 mg/day, Etoposide 50 mg/day, and Procarbazine 50 mg/day

10

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 Patricia Glynn
212-746-6738
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.

11

Disease Status and/or Stage Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Protocol Title A Phase II Study of SGN-40 (anti-huCD40 mAb) in patients with Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
PI Richard Furman, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility

Adult subjects with histologic diagnosis of diffuse large B-cell lymphoma who have progressed or relapsed since the most receive therapy.
Treatment Overview All eligible patients will receive 6 intravenous infusions of study drug over 5 weeks using a previously tested dosing schedule. Patients who meet criteria for clinical benefit after cycle 2 of treatment, may continue to receive additional treatment for a total of 12 cycles.

12

Disease Status and/or Stage Relapsed or Refractory Non-Hodgkin's Lymphoma
Protocol Title NCIC LY.12: A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R)-GDP vs. (R)-DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab vs. Observation
PI Tsiporah Shore, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

Diffuse large cell lymphoma; previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at relapse; peripheral T-cell lymphoma; anaplastic large cell lymphoma (ALCL); small non-cleaved Burkitt-like lymphoma.

Treatment Overview

Salvage Therapy:
Randomization #1 - (R)-GDP or (R)-DHAP. Patients with CD20+ B cell lymphoma will also receive rituximab.

Maintenance Therapy:
Randomization #2 - Rituximab or observation.

13

Disease Status and/or Stage Relapsed Mantle Cell Lymphoma
Protocol Title A Pilot Study of PD 0332991 in Patients with Previously Treated Mantle Cell Lymphoma
PI John Leonard, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility

Adult subjects with histologically documented MCL that is CD20 (or CD19) positive, CD5 positive, CD23 negative AND at least one of the following: positive immunostaining for cyclin D1, presence of T 911; 14) on cytogenetic analysis, or molecular evidence of bc1-1/IgH rearrangement. Subjects should have also received at least one prior therapy and prior radiation therapy both completed great than 3 weeks prior to study enrollment.

Treatment Overview

Patients will receive cycles of only daily oral dosing of 125 mg for 3 consecutive weeks followed by a 1-week rest period

14

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.

15

Disease Status and/or Stage Untreated Follicular Non-Hodgkin's Lymphoma
Protocol Title CALGB 50701: A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody)(CALGB IND #101241) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin’s Lymphoma (NHL)
PI John Leonard, MD
Contact Patricia Glynn, RN
212-746-6738
Key Eligibility

Previously untreated, histologically confirmed follicular NHL. No prior therapoy for NHL including chemotherapy, radiation, or immunotherapy (e.g., monoclonal antibody-based therapy).

Treatment Overview

Treatment on this study will consist of two parts:
1) Induction Therapy
2) Extended Induction Therapy
Induction therapy will consist of two drugs epratuzumab + rituximab.
Extended Induction Therapy - Following Induction Therapy, the combination of epratuzumab and rituximab will be given every other month to cover a total of nine months (that is, during months 3, 5, 7 and 9).

16

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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