The Temple Bone Marrow Transplant Program is participating in the following clinical trials:
For Non-Hodgkin's Lymphoma
Title: A Phase II Study of the Monoclonal Antibody CT-011 in Patients with Diffuse Large Cell Lymphoma following Autologous Peripheral Blood Stem Cell Transplantation
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 #11620. WIRB Protocol #20080617.
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.
Title: A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate; OMA) in the Treatment of Patients with Chronic Myeloid Leukemia (CML) Who have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy
To evaluate the safety and efficacy of subcutaneous administration of homoharringtonine (OMA) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. 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 #11338. WIRB Protocol #20071873.
For Graft vs. Host Disease
Title: A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal™ (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Patients who have failed to respond to Steroid Treatment for Acute GVHD
For patients up to age 70 years who have failed to respond to steroid treatment of acute graft-versus-host disease, post allogeneic hematopoietic stem cell transplant or post donor leukocyte infusion. Cannot have started 2nd line therapy for more 24 hours. Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol # 11787. FIRB Protocol #07-902.
For Acute Myeloid Leukemia
E 1900: A phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-intensification Prior to Risk Allocated Autologous Stem Cell Transplant
This trial looks at the effect of escalated dose anthracycline in the induction phase of leukemic therapy followed by biologic randomization between autologous or allogeneic stem cell transplant.
Inclusion Criteria:
16 years < 61 years of age
Newly diagnosed AML patients with > 20 % blasts in the peripheral blood or marrow
Patients must not have been previously treated with radiation therapy or cytotoxic chemotherapy
Based on the WHO Classification of AML the following will be excluded:
AML with recurrent cytogenetic translocations
Acute PML with t(15;17)(q22;q21)
Variant acute PML with t(v;17)
AML with multilineage dysplasia
With prior myelodysplastic syndrome
Other types
Acute panmyelosis with myelofibrosis
Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol # 4285. FIRB Protocol #04-211.
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 elderly leukemic patients, ages 60-75.
Population:
Age > 60 years and < 75 years
Patients 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 Myeloma
CALBG 10014/ECOG 10104: A Phase III Randomized, Double-Blind Study of Maintenance Therapy with CC-5013 (NSC #703813, IND #70116) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma
This trial randomizes multiple myeloma patients to receive revlimid post-autologous transplant. The autologous transplant is done using a standard high-dose melphalan conditioning regimen with peripheral blood stem cells.
Inclusion Criteria:
Age > 18 and < 70 years
Patients must have active multiple myeloma requiring treatment (Durie-Salmon stage >1) and have stable disease or be responsive to at least 2 months of any induction therapy.
Patients must not have had more than 12 months of any prior therapy, including CC-55013 and thalidomide
Patients must be within 12 months of initiation of induction therapy
Patients with prior progression after initial therapy will be excluded
Patients with prior peripheral blood, bone marrow, or solid organ transplant will be excluded
Reviewed and approved by the Temple University Institutional Review Board and assigned Protocol #10375. FIRB Protocol #06-902.
For information or to enroll a patient, call 215-214-4191.
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