A Phase 2 interventional study of asparaginase and cyclophosphamide in Leukemia and Lymphoma, sponsored by National Institutes of Health Clinical Center (CC). Completed at 5 sites in 3 countries. Per ClinicalTrials.gov, last updated 2012-02-20.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of two treatment regimens for patients in developing countries with diffuse non-Hodgkin's lymphoma and acute lymphoblastic leukemia.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma with any degree of bone marrow involvement are assigned to Protocol MCP-841. Patients with mediastinal or localized lymphoblastic lymphoma (a single nodal or extranodal site) without bone marrow involvement, or other types of diffuse non-Hodgkin's lymphoma with or without bone marrow involvement are assigned to Protocol MCP-842.
Protocol MCP-841:
Patients with low-risk disease (WBC no greater than 10,000/mm3, age 3 to 6 years, no prominent lymphadenopathy (less than 3 cm in diameter in each nodal region), normal CSF, no mediastinal mass, no enlargement of liver or spleen, and no cranial nerve palsies) proceed directly to maintenance therapy. All other patients are considered high risk, and they repeat first induction therapy and then proceed to consolidation therapy.
Protocol MCP-842:
Patients are followed every 2 months for 1 year (Protocol MCP-841) or at 1, 2, 3, 4, 6, and 8 months (Protocol MCP-842), every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
Browse Leukemia studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Newly diagnosed acute lymphoblastic leukemia (ALL)
Lymphoblasts comprising more than 25% of nucleated cells on bone marrow aspirate
PATIENT CHARACTERISTICS:
Age:
ALL:
NHL:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institutes of Health Clinical Center (CC) →