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Lymphoma and Multiple Myeloma

Non-Hodgkin's Lymphoma (NHL)

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Disease type
Treatment Status

Protocol Title
(click on title for more information)

2
Follicular
Relapsed

CALGB 50401: A Randomized Phase II Trial of Rituximab vs. Lenalidomide (Revlimid, CC-5013) (IND #73034) vs. Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) After Relapse from a Rituximab-Containing Regimen

3
DLBCL

Front Line receiving
R-CHOP

4

DLBCL
Front Line
CALGB 50303: Phase III Randomized Study of R-CHOP vs. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-cell Lymphomas
5
DLBCL
Relapsed
Phase II Trial of "VIPER" Chemotherapy in Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma (NHL)
6
DLBCL
Relapsed
A Phase II, Single-Institution, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of a Single Agent Dasatinib (Sprycel®) in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
8

DLBCL/
Mantle Cell

Relapsed
Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas
14
All B-Cell Malignancies
Relapsed
Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B-Cell Malignancies
15
All Hematologic Malignancies
Relapsed
19
Non-Hodgkin's Lymphoma

Relapsed or Refractory

Phase 1 Study of Radiosensitization using Bortezomib in Patients with Relapsed Non-Hodgkin’s Lymphoma receiving Radioimmunotherapy

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2

Disease Status and/or Stage Reurrent Follicular Non-Hodgkin's Lymphoma
Protocol Title CALGB 50401: A Randomized Phase II Trial of Rituximab vs. Lenalidomide (Revlimid, CC-5013) (IND #73034) vs. Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) After Relapse from a Rituximab-Containing Regimen
PI John Leonard, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility Patients must have histologically confirmed follicle center cell lymphoma and have been treated with rituximab either alone or in combination with chemotherapy. The last prior treatment regimen need not include rituximab. Patients must have progressed greater than or equal to 6 months from the last dose of rituximab in order to be eligible.
Treatment Overview

Patients will be randomized to one of the following two treatment arms:

Arm A: Lenalidomide Alone
The starting dose of lenalidomide will be 15 mg/day PO on days 1-21 followed by 7 days of rest. After cycle 2, the dose will be escalated in patients who have not had therapy delayed and who have recovered from previous toxicity. Maximum dose will be 25 mg/day. In the absence of intolerable toxicity or disease progression, lenalidomide will be given for a total of twelve cycles.

Arm B: Rituximab + Lenalidomide
Lenalidomide will be administered same as stated in Arm A. Rituximab will be administered at a dose of 375 mg/m2 by IV on Days 8, 5, 22 and 29 beginning one week after initiation of lenalidomide. Patients will receive four weekly infusions of rituximab, and twelve cycles of lenalidomide.

Restaging for both Arms will be during months 2, 4, 6, 9, 12, 15, 18, and 24, and then yearly until disease progression or for a maximum of ten years from study entry.

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3

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 June Greenberg, RN
212-746-2651
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)

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4

Disease Status and/or Stage Untreated De Novo Diffuse Large B-cell Lymphoma
Protocol Title CALGB 50303: Phase III Randomized Study of R-CHOP vs. Dose-Adjusted EPOCH-R with Molecular Profiling in Untreated De Novo Diffuse Large B-cell Lymphomas
PI John Leonard, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility Untreated patients with histologically documented de novo CD20+ diffuse large b-cell lymphoma with stage II, III, or IV disease
Treatment Overview

Patients will be randomized to one of two treatment arms:
Arm A - Patients will receive R-CHOP Chemotherapy
Arm B - Patients receive dose-adjusted EPOCH-R Chemotherapy

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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 June Greenberg, RN
212-746-2651
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.

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6

Disease Status and/or Stage Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Protocol Title A Phase II, Single-Institution, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of a Single Agent Dasatinib (Sprycel®) in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
PI Rebecca Elstrom , MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

Adult subjects with histologic diagnosis of diffuse large B-cell lymphoma who have progressed or relapsed since the most receive therapy. Subjects must have received at least one prior combination chemotherapy regimen.
There is no limit on the number of prior therapies.

Treatment Overview Treatment Phase consists of single agent dasatinib 100mg once daily on Days 1-28 every 28 days (28 day cycles). Subjects may continue participation in the Treatment Phase of the study until disease progression or unacceptable AEs develop.

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8

Disease Status and/or Stage Relapsed or Refractory Mantle Cell or Diffuse Large B-Cell Lymphoma
Protocol Title Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas
PI Rebecca Elstrom , MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

Histologically confirmed mantle cell or diffuse large B-cell lymphoma receiving at least one prior systemic therapy. DLBCL patients are not eligible if they received bortezomib.

Treatment Overview

Patients will receive: Vorinostat 400 mg (total daily dose as a single dose) on days 1-5 and 8-12. Bortezomib 1.3 mg/m2/d IV on days 1, 4, 8, and 11.

Regimen is repeated every 3 weeks.

Patients who experience a complete or partial response following at least one year of treatment may go off study treatment but remain on study and resume study treatment upon disease progression if the study remains open.

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14

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.

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15

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.

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19

Disease Status and/or Stage Relapsed or Refractory Non-Hodgkin's Lymphoma
Protocol Title Phase 1 Study of Radiosensitization using Bortezomib in Patients with Relapsed Non-Hodgkin’s Lymphoma receiving Radioimmunotherapy
PI Rebecca Elstrom, MD
Contact June Greenberg, RN
212-746-2651
Key Eligibility

Patients must have histologically proven relapsed or refractory MCL, DLBCL including subtypes mediastinal large B cell, centroblastic, immunoblastic, T-cell rich B- cell and anaplastic large B-cell lymphoma, or low grade B-cell NHL.

Treatment Overview

Bortezomib is administered to Patients twice weekly, with the first dose being given two days prior to the treatment dose of 131I-Tositumomab, and the second dose two days after Radioimmunotherapy (RIT) for a total of 5 doses.

 
Last updated: January 5, 2011
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