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| Sponsored by: |
St. Jude Children's Research Hospital |
|---|---|
| Information provided by: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00187161 |
Purpose
This is a pilot study to demonstrate that the modified LMB-89 treatment regimen for children with newly diagnosed small noncleaved cell NHL, large cell NHL (B-cell), and B-cell acute lymphoblastic leukemia can be delivered in this setting with acceptable toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin Lymphoma Acute Lymphoblastic Leukemia, Mature B-Cell |
Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Small Noncleaved Cell (SNCC), Non-Hodgkin Lymphoma (NHL), Large Cell NHL (B-Cell) and B-Cell Acute Lymphoblastic Leukemia (B-ALL) Study II |
| Enrollment: | 68 |
| Study Start Date: | November 1994 |
| Study Completion Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Group A: Resected Stage I and resected abdominal Stage II Subjects will receive two courses (3 weeks apart) of COPAD. |
Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
The additional information is contained in the Detailed Description section.
|
|
B: Experimental
Group B: Other Stage II, Stage III, Stage IV or B-ALL M blast <70%; no CNS involvement. Subjects in Group B will receive one week of treatment of COP. |
Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
The additional information is contained in the Detailed Description section.
|
|
C: Experimental
Group C: B-ALL with >70% BM blasts; CNS involvement, Group B COP failures i.e., <20% reduction Treatment Pre-Induction Subjects will receive one week of treatment of COP. |
Drug: Prednison, Vincristine, Cytarabine, Methotrexate, Etoposide, Cyclophosphamide, Doxorubicin
The additional information is contained in the Detailed Description section.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Principal Investigator: | John T. Sandlund, M.D. | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | St. Jude Children's Research Hospital ( John T. Sandlund, MD / Principal Investigator ) |
| Study ID Numbers: | SJBCII |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00187161 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Mature B-Cell Leukemia Non-Hodgkin Lymphoma Burkitt's lymphoma Small noncleaved cell non Hodgkin lymphoma Large cell lymphoma |
|
Antimetabolites Leukemia, Lymphoid Immunologic Factors Cyclophosphamide Etoposide phosphate Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Anti-Bacterial Agents Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Methotrexate Epstein-Barr Virus Infections Leukemia, B-cell, Chronic Lymphoma, Large-cell Alkylating Agents |
Etoposide Lymphoma Acute Lymphoblastic Leukemia Cytarabine Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Vincristine Folic Acid Antagonists Immunosuppressive Agents Doxorubicin Herpesviridae Infections Folic Acid Virus Diseases Lymphatic Diseases |
|
Antimetabolites Leukemia, Lymphoid Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Tumor Virus Infections Reproductive Control Agents Cyclophosphamide Antibiotics, Antineoplastic Neoplasms, Experimental Lymphoma, B-Cell Leukemia Therapeutic Uses |
Abortifacient Agents Methotrexate Epstein-Barr Virus Infections Dermatologic Agents Alkylating Agents Lymphoma Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents |
