Clinical Trials & Research

The Temple Bone Marrow Transplant Program offers state-of-the-art clinical trials, including one-of-a-kind studies conducted only at Temple. We currently are participating in the following trials:

For Patients Without Matched Donors

Title: A Phase II Study of Nonmyeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients with Hematologic Malignancies

The objective of this study is to determine the safety of using half matched or "haplo" identical bone marrow cells as allogeneic grafting cells in patients with certain hematologic malignancies. These include patients with acute lymphobalstic leukemia/lymphoma, acute myeloid leukemia, Burkitt's lymphoma, relapsed lymphoma but not myeodysplatic syndrome (MDS).

Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol #12-021. FIRB Protocol #08-903.

For Non-Hodgkin's Lymphoma

Title: A Phase II Study of the antibody CT-011 after autologous transplant for patients with Large Cell Non Hodgkins Lymphoma

The objectives of this study are to determine the safety and efficacy of CT-011 (1.5 mg/kg, three courses of treatment separated by 42 days) in patients over 18 years of age with Diffuse Large Cell Lymphoma who have not progressed by 30 days following autologous peripheral blood stem cell transplantation (50-65 days post transplant) compared to their pre-transplantation status, as determined by CT scan. Progression is defined as the appearance of new lesions on CT scan and/or an increase of nodal size by > 50%.

Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol #11664. WIRB Protocol #20080617.

Title: BMT CTN 0701: A Phase II Trial of Non-Myeloablative Allogeneic Transplant for Patients with Relapsed Follicular Non-Hodgkin's Lymphoma Beyond First Complete Response

The objectives of this study are to determine the safety and efficacy of a non-myeloablative allogenic conditioning regimen, FCR, for treating patients with relapsed follicular lymphoma that has not transformed (large cell or grade III disease). Eligible patients are < 75 years old and have histologically confirmed recurrent follicular lymphoma, grade I or II (WHO classification grade 1, 2 or 3a). Patients must have chemosensitive disease by achieving lymph node axial diameter < 3cm or >50% reduction in nodal diameter after recent salvage therapy. 

Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol #12454. FIRB Protocol #09-905.

For Chronic Myeloid Leukemia

Title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine) (CGX-635) in the Treament of Patients with Chronic Myeloid Leukemia (CML) with the T315I BCR-ABL Gene Mutation

To evaluate the safety and efficacy of subcutaneous administration of Omacetaxine (OMA) in achieving a clinical response in CML patients in chronic, accelerated or blast phase who have the T315I BCR-ABL gene mutation. OMA is given BID x 14 days during induction followed by BID x 7 days during maintenance with each cycle equaling 28 days.

Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol #11337. WIRB Protocol #20071870.

For Acute Myeloid Leukemia and MDS

Title: E 1905: A Randomized Phase II Study of Azacitidine with or without the Histone Deacetylase Inhibitor MS-275 for the treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (dysplastic type), and Acute Myeloid Leulemia with Mutilineage Dysplasia

This trial comares the effect of the Azacitidine with our whithout the experimental agent MS-275 in patients with dysplastic AML, dysplastic CMML or myelodysplastic syndrome (MDS). MDS with any IPSS score and < 20 % blasts in the peripheral blood or marrow. Patient with low IPSS score must have a platelet count < 50,000 or an absolute neutrophil count < 500 within a week or registration OR CMML, dysplastic type OR AML with mutilineage dysplasia. No therapy induced leukemia. Age > 16, ECOG 0-2, no prior treatment with Azacitidine or MS-275

Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol # 12136. FIRB Protocol #06-211.

Title: BMT CTN 0502: A Phase II study of Allogeneic Transplant for Older Patients with AML in First Morphologic Complete Remission Using a Non-Myeloablative Preparative Regimen

This trial evaluates the place of mini allogeneic transplant using a conditioning regimen of fludarabine, busulfan and ATG in patients, ages 60-75, with AML (excluding FAB M3) who have achieved a first morphologic complete remission. Patients with preceding MDS or treatment-related AML are eligible. CR must have been achieved after no more than two cycles of induction chemotherapy. Patients may have received as many as but no more than two cycles of consolidation therapy prior to transplant. No more than 6 months can elapse from documentation of morphologic CR to transplant. Patients with acute leukemia following blast transformation of prior CML or other myeloproliferative disease are excluded

Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol # 11426. FIRB Protocol #08-901.

For Acute Graft Versus Host Disease (GVHD)

Title: BDP-GVHD: A Trial of the agent BDP in the treatment of early acute GI GVHD

This trial evaluates the use of a non-absorbed steroid preparation, BDP, for the treatment of acute GVHD of the GI tract. Patients must have biopsy proven GVHD with less than a liter of diarrhea each day, bilirubin < 3 and no more than 50% GVHD skin rash.

Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol # 12469. WIRB Protocol #20091282.

For information or to enroll a patient, please call the Temple Bone Marrow Transplant Program at 215-214-3122.

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