Treating Patients With Childhood Acute Myeloid Leukemia With Interleukin-2

Leukemia Clinical Trial

— Elam02  

Official title:

Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00149162
• Other study ID #: P030441
• Secondary ID: AOM 03142
• Status: Recruiting
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: February 11, 2009
• Start date: March 2005
• Est. completion date: March 2012

Study information

• Verified date: February 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Guy Leverger, M.D.
• Phone: 33 1 44 73 60 62
• Email: guy.leverger[@]trs.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

Description:

We designed an open randomized study to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival. A total of 580 patients will be accrued over 7 years. Treatment consists in subcutaneous application of interleukin-2 in treating patients with complete remission by a monthly regimen of 5 days during 1 year after having received a chemotherapy consisting of 1 induction and 3 consolidation treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: March 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age: 0 to 18 years

• Prior untreated acute myeloid leukemia (AML) of following cytological types : FAB M0, M1, M2, M4, M4 eosinophil, M5, M6, M7, without FAB classification or showing myelodysplasia (blasts > 20 %)

• Isolated myeloid sarcoma

• Achieved complete remission

• No HLA identical family donor, except for the patients with t(8;21)

• No contraindication for the use of interleukin-2

Exclusion Criteria:

• Trisomy 21

• Promyelocytic leukemia (M3) or M3 variations

• Secondary AML

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• proleukin
One cycle of treatment : D1 : 2.5 MUI/m2 (subcutaneous); D2 to D5 : 5 MUI / m2 (subcutaneous) 1 cycle of treatment each month during 12 months

Locations

Country	Name	City	State
France	Children Armand Trousseau Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Chiron Corporation

Country where clinical trial is conducted

France, 

References & Publications (19)

Béhar C, Suciu S, Benoit Y, Robert A, Vilmer E, Boutard P, Bertrand Y, Lutz P, Ferster A, Tokaji E, Manel AM, Solbu G, Otten J. Mitoxantrone-containing regimen for treatment of childhood acute leukemia (AML) and analysis of prognostic factors: results of the EORTC Children Leukemia Cooperative Study 58872. Med Pediatr Oncol. 1996 Mar;26(3):173-9. — View Citation

Burnett AK, Goldstone AH, Stevens RM, Hann IM, Rees JK, Gray RG, Wheatley K. Randomised comparison of addition of autologous bone-marrow transplantation to intensive chemotherapy for acute myeloid leukaemia in first remission: results of MRC AML 10 trial. UK Medical Research Council Adult and Children's Leukaemia Working Parties. Lancet. 1998 Mar 7;351(9104):700-8. — View Citation

Byrd JC, Dodge RK, Carroll A, Baer MR, Edwards C, Stamberg J, Qumsiyeh M, Moore JO, Mayer RJ, Davey F, Schiffer CA, Bloomfield CD. Patients with t(8;21)(q22;q22) and acute myeloid leukemia have superior failure-free and overall survival when repetitive cycles of high-dose cytarabine are administered. J Clin Oncol. 1999 Dec;17(12):3767-75. — View Citation

Cortes JE, Kantarjian HM, O'Brien S, Giles F, Keating MJ, Freireich EJ, Estey EH. A pilot study of interleukin-2 for adult patients with acute myelogenous leukemia in first complete remission. Cancer. 1999 Apr 1;85(7):1506-13. Review. — View Citation

Creutzig U, Ritter J, Zimmermann M, Reinhardt D, Hermann J, Berthold F, Henze G, Jürgens H, Kabisch H, Havers W, Reiter A, Kluba U, Niggli F, Gadner H. Improved treatment results in high-risk pediatric acute myeloid leukemia patients after intensification with high-dose cytarabine and mitoxantrone: results of Study Acute Myeloid Leukemia-Berlin-Frankfurt-Münster 93. J Clin Oncol. 2001 May 15;19(10):2705-13. — View Citation

Foa R, Caretto P, Fierro MT, Bonferroni M, Cardona S, Guarini A, Lista P, Pegoraro L, Mandelli F, Forni G, et al. Interleukin 2 does not promote the in vitro and in vivo proliferation and growth of human acute leukaemia cells of myeloid and lymphoid origin. Br J Haematol. 1990 May;75(1):34-40. — View Citation

Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52. — View Citation

Leblanc T, Berger R. Molecular cytogenetics of childhood acute myelogenous leukaemias. Eur J Haematol. 1997 Jul;59(1):1-13. Review. — View Citation

Lie SO, Jonmundsson G, Mellander L, Siimes MA, Yssing M, Gustafsson G. A population-based study of 272 children with acute myeloid leukaemia treated on two consecutive protocols with different intensity: best outcome in girls, infants, and children with Down's syndrome. Nordic Society of Paediatric Haematology and Oncology (NOPHO). Br J Haematol. 1996 Jul;94(1):82-8. — View Citation

Lipshultz SE, Colan SD, Gelber RD, Perez-Atayde AR, Sallan SE, Sanders SP. Late cardiac effects of doxorubicin therapy for acute lymphoblastic leukemia in childhood. N Engl J Med. 1991 Mar 21;324(12):808-15. — View Citation

Maraninchi D, Blaise D, Viens P, Brandely M, Olive D, Lopez M, Sainty D, Marit G, Stoppa AM, Reiffers J, et al. High-dose recombinant interleukin-2 and acute myeloid leukemias in relapse. Blood. 1991 Nov 1;78(9):2182-7. — View Citation

Meloni G, Foa R, Vignetti M, Guarini A, Fenu S, Tosti S, Tos AG, Mandelli F. Interleukin-2 may induce prolonged remissions in advanced acute myelogenous leukemia. Blood. 1994 Oct 1;84(7):2158-63. — View Citation

Mertens AC, Wen W, Davies SM, Steinbuch M, Buckley JD, Potter JD, Robison LL. Congenital abnormalities in children with acute leukemia: a report from the Children's Cancer Group. J Pediatr. 1998 Nov;133(5):617-23. — View Citation

Michel G, Baruchel A, Tabone MD, Nelken B, Leblanc T, Thuret I, Bordigoni P, Bergeron C, Esperou-Bourdeau H, Perel Y, Vannier JP, De Lumley L, Dommergues JP, Lamagnère JP, Couillaud G, Auvrignon A, Schaison G, Leverger G. Induction chemotherapy followed by allogeneic bone marrow transplantation or aggressive consolidation chemotherapy in childhood acute myeloblastic leukemia. A prospective study from the French Society of Pediatric Hematology and Immunology (SHIP). Hematol Cell Ther. 1996 Apr;38(2):169-76. — View Citation

Michel G, Leverger G, Leblanc T, Nelken B, Baruchel A, Landman-Parker J, Thuret I, Bergeron C, Bordigoni P, Esperou-Bourdeau H, Perel Y, Vannier JP, Schaison G. Allogeneic bone marrow transplantation vs aggressive post-remission chemotherapy for children with acute myeloid leukemia in first complete remission. A prospective study from the French Society of Pediatric Hematology and Immunology (SHIP). Bone Marrow Transplant. 1996 Feb;17(2):191-6. — View Citation

Oshimi K, Oshimi Y, Akutsu M, Takei Y, Saito H, Okada M, Mizoguchi H. Cytotoxicity of interleukin 2-activated lymphocytes for leukemia and lymphoma cells. Blood. 1986 Oct;68(4):938-48. — View Citation

Perel Y, Auvrignon A, Leblanc T, Vannier JP, Michel G, Nelken B, Gandemer V, Schmitt C, Lamagnere JP, De Lumley L, Bader-Meunier B, Couillaud G, Schaison G, Landman-Parker J, Thuret I, Dalle JH, Baruchel A, Leverger G; Group LAME of the French Society of Pediatric Hematology and Immunology. Impact of addition of maintenance therapy to intensive induction and consolidation chemotherapy for childhood acute myeloblastic leukemia: results of a prospective randomized trial, LAME 89/91. Leucámie Aiqüe Myéloïde Enfant. J Clin Oncol. 2002 Jun 15;20(12):2774-82. — View Citation

Wells RJ, Woods WG, Buckley JD, Odom LF, Benjamin D, Bernstein I, Betcher D, Feig S, Kim T, Ruymann F, et al. Treatment of newly diagnosed children and adolescents with acute myeloid leukemia: a Childrens Cancer Group study. J Clin Oncol. 1994 Nov;12(11):2367-77. — View Citation

Wells RJ, Woods WG, Lampkin BC, Nesbit ME, Lee JW, Buckley JD, Versteeg C, Hammond GD. Impact of high-dose cytarabine and asparaginase intensification on childhood acute myeloid leukemia: a report from the Childrens Cancer Group. J Clin Oncol. 1993 Mar;11(3):538-45. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interest of interleukin-2 in complete remission after induction and consolidation chemotherapy concerning the event free survival (event = relapse of toxic death)		1 year	Yes
Secondary	Analyze the whole toxicity of the regimen		1 year	Yes
Secondary	Examine the prognostic biological factors		1 year	No