Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.

Timeline

Start

2000-06

Primary completion

2008-08

Completion

2015-03-31

Outcome

Missed primary endpoint

registry p = .97; Regression, Cox NCT00004228 ↗

registry p = .63; Regression, Cox NCT00004228 ↗

Publications

• Results Patel JL, Smith LM, Anderson J, Abromowitch M, Campana D, Jacobsen J, Lones MA, Gross TG, Cairo MS, Perkins SL. The immunophenotype of T-lymphoblastic lymphoma in children and adolescents: a Children's Oncology Group report. Br J Haematol. 2012 Nov;159(4):454-61. doi: 10.1111/bjh.12042. Epub 2012 Sep 21.
• Results Termuhlen AM, Smith LM, Perkins SL, Lones M, Finlay JL, Weinstein H, Gross TG, Abromowitch M. Outcome of newly diagnosed children and adolescents with localized lymphoblastic lymphoma treated on Children's Oncology Group trial A5971: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Dec 15;59(7):1229-33. doi: 10.1002/pbc.24149. Epub 2012 Apr 5.
• Results Coustan-Smith E, Sandlund JT, Perkins SL, Chen H, Chang M, Abromowitch M, Campana D. Minimal disseminated disease in childhood T-cell lymphoblastic lymphoma: a report from the children's oncology group. J Clin Oncol. 2009 Jul 20;27(21):3533-9. doi: 10.1200/JCO.2008.21.1318. Epub 2009 Jun 22.
• Results Abromowitch M, Termuhlen A, Chang M, et al.: High-dose methotrexate and early intensification of therapy do not improve 3 year EFS in children and adolescents with disseminated lymphoblastic lymphoma: results of the randomized arms of COG A5971. [Abstract] Blood 112 (11): A-3610, 2008.
• Results Smock KJ, Nelson M, Tripp SR, Sanger WG, Abromowitch M, Cairo MS, Perkins SL; Children's Oncology Group. Characterization of childhood precursor T-lymphoblastic lymphoma by immunophenotyping and fluorescent in situ hybridization: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Oct;51(4):489-94. doi: 10.1002/pbc.21666.
• Results Coustan-Smith E, Abromowitz M, Sandlund JT, et al.: A novel approach for minimal residual disease detection in childhood T-cell lymphoblastic lymphoma (T-LL): a Children's Oncology Group report. [Abstract] Blood 110 (11): A-3564, 2007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	—	Intravenous
Subject	Cytarabine	Small molecule	—	Intravenous
Subject	Daunorubicin	Small molecule	—	Intravenous
Subject	Dexamethasone	Small molecule	—	Intravenous
Subject	Doxorubicin	Other / unclassified	—	Intravenous
Subject	MERCAPTOPURINE ANHYDROUS	Small molecule	—	Intravenous
Subject	Methotrexate	Small molecule	—	Intravenous
Subject	Prednisone	Other / unclassified	—	Intravenous
Subject	Thioguanine	Small molecule	—	Oral
Subject	Vincristine	Small molecule	—	Intravenous
Subject	asparaginase	Protein / enzyme biologic	—	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous

Indications