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| 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: 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. |
| 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) |
| 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: |
| 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. |
| 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. |
| 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. |
| 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. 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. |
| 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 |
| 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. |
| 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. |