AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia: A report from the Children's Oncology Group

Todd M. Cooper, Janet Franklin, Robert B. Gerbing, Todd A. Alonzo, Craig Hurwitz, Susana C. Raimondi, Betsy Hirsch, Franklin O. Smith, Prasad Mathew, Robert J. Arceci, James Feusner, Robert Iannone, Robert S. Lavey, Soheil Meshinchi, Alan Gamis

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The development of antigen-targeted therapies may provide additional options to improve outcomes in children with acute myeloid leukemia (AML). The Children's Oncology Group AAML03P1 trial sought to determine the safety of adding 2 doses of gemtuzumab ozogamicin, a humanized anti-CD33 antibody-targeted agent, to intensive chemotherapy during remission induction and postremission intensification for children with de novo AML. METHODS: AAML03P1 enrolled 350 children with previously untreated AML. Patients with a matched family donor received 3 courses of chemotherapy followed by hematopoietic stem cell transplantation; those without a matched family donor received 5 courses of chemotherapy. Gemtuzumab ozogamicin 3 mg/m 2/dose was administered on Day 6 of Course 1 and Day 7 of Course 4. RESULTS: Toxicities observed in all courses of therapy were typical of AML chemotherapy regimens, with infection being most common. Patients achieved a complete remission rate of 83% after 1 course and 87% after 2 courses. The mortality rate was 1.5% after the first gemtuzumab ozogamicin-containing induction course and 2.6% after 2 induction courses. The 3-year event-free survival and overall survival rates were 53 ± 6% and 66 ± 5%, respectively. CONCLUSIONS: This trial determined that it is safe and feasible to include gemtuzumab ozogamicin in combination with intensive chemotherapy. The survival rates compare favorably with the recently published results of clinical trials worldwide.

Original languageEnglish (US)
Pages (from-to)761-769
Number of pages9
JournalCancer
Volume118
Issue number3
DOIs
StatePublished - Feb 1 2012

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Combination Drug Therapy
Acute Myeloid Leukemia
Safety
Drug Therapy
Survival Rate
Tissue Donors
Antibodies, Monoclonal, Humanized
Remission Induction
Hematopoietic Stem Cell Transplantation
Disease-Free Survival
Anti-Idiotypic Antibodies
gemtuzumab
Clinical Trials
Antigens
Mortality
Therapeutics
Infection

Keywords

  • AAML03P1
  • childhood acute myeloid leukemia
  • children
  • gemtuzumab ozogamicin
  • newly diagnosed

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia : A report from the Children's Oncology Group. / Cooper, Todd M.; Franklin, Janet; Gerbing, Robert B.; Alonzo, Todd A.; Hurwitz, Craig; Raimondi, Susana C.; Hirsch, Betsy; Smith, Franklin O.; Mathew, Prasad; Arceci, Robert J.; Feusner, James; Iannone, Robert; Lavey, Robert S.; Meshinchi, Soheil; Gamis, Alan.

In: Cancer, Vol. 118, No. 3, 01.02.2012, p. 761-769.

Research output: Contribution to journalArticle

Cooper, TM, Franklin, J, Gerbing, RB, Alonzo, TA, Hurwitz, C, Raimondi, SC, Hirsch, B, Smith, FO, Mathew, P, Arceci, RJ, Feusner, J, Iannone, R, Lavey, RS, Meshinchi, S & Gamis, A 2012, 'AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia: A report from the Children's Oncology Group', Cancer, vol. 118, no. 3, pp. 761-769. https://doi.org/10.1002/cncr.26190
Cooper, Todd M. ; Franklin, Janet ; Gerbing, Robert B. ; Alonzo, Todd A. ; Hurwitz, Craig ; Raimondi, Susana C. ; Hirsch, Betsy ; Smith, Franklin O. ; Mathew, Prasad ; Arceci, Robert J. ; Feusner, James ; Iannone, Robert ; Lavey, Robert S. ; Meshinchi, Soheil ; Gamis, Alan. / AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia : A report from the Children's Oncology Group. In: Cancer. 2012 ; Vol. 118, No. 3. pp. 761-769.
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abstract = "BACKGROUND: The development of antigen-targeted therapies may provide additional options to improve outcomes in children with acute myeloid leukemia (AML). The Children's Oncology Group AAML03P1 trial sought to determine the safety of adding 2 doses of gemtuzumab ozogamicin, a humanized anti-CD33 antibody-targeted agent, to intensive chemotherapy during remission induction and postremission intensification for children with de novo AML. METHODS: AAML03P1 enrolled 350 children with previously untreated AML. Patients with a matched family donor received 3 courses of chemotherapy followed by hematopoietic stem cell transplantation; those without a matched family donor received 5 courses of chemotherapy. Gemtuzumab ozogamicin 3 mg/m 2/dose was administered on Day 6 of Course 1 and Day 7 of Course 4. RESULTS: Toxicities observed in all courses of therapy were typical of AML chemotherapy regimens, with infection being most common. Patients achieved a complete remission rate of 83{\%} after 1 course and 87{\%} after 2 courses. The mortality rate was 1.5{\%} after the first gemtuzumab ozogamicin-containing induction course and 2.6{\%} after 2 induction courses. The 3-year event-free survival and overall survival rates were 53 ± 6{\%} and 66 ± 5{\%}, respectively. CONCLUSIONS: This trial determined that it is safe and feasible to include gemtuzumab ozogamicin in combination with intensive chemotherapy. The survival rates compare favorably with the recently published results of clinical trials worldwide.",
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AU - Franklin, Janet

AU - Gerbing, Robert B.

AU - Alonzo, Todd A.

AU - Hurwitz, Craig

AU - Raimondi, Susana C.

AU - Hirsch, Betsy

AU - Smith, Franklin O.

AU - Mathew, Prasad

AU - Arceci, Robert J.

AU - Feusner, James

AU - Iannone, Robert

AU - Lavey, Robert S.

AU - Meshinchi, Soheil

AU - Gamis, Alan

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N2 - BACKGROUND: The development of antigen-targeted therapies may provide additional options to improve outcomes in children with acute myeloid leukemia (AML). The Children's Oncology Group AAML03P1 trial sought to determine the safety of adding 2 doses of gemtuzumab ozogamicin, a humanized anti-CD33 antibody-targeted agent, to intensive chemotherapy during remission induction and postremission intensification for children with de novo AML. METHODS: AAML03P1 enrolled 350 children with previously untreated AML. Patients with a matched family donor received 3 courses of chemotherapy followed by hematopoietic stem cell transplantation; those without a matched family donor received 5 courses of chemotherapy. Gemtuzumab ozogamicin 3 mg/m 2/dose was administered on Day 6 of Course 1 and Day 7 of Course 4. RESULTS: Toxicities observed in all courses of therapy were typical of AML chemotherapy regimens, with infection being most common. Patients achieved a complete remission rate of 83% after 1 course and 87% after 2 courses. The mortality rate was 1.5% after the first gemtuzumab ozogamicin-containing induction course and 2.6% after 2 induction courses. The 3-year event-free survival and overall survival rates were 53 ± 6% and 66 ± 5%, respectively. CONCLUSIONS: This trial determined that it is safe and feasible to include gemtuzumab ozogamicin in combination with intensive chemotherapy. The survival rates compare favorably with the recently published results of clinical trials worldwide.

AB - BACKGROUND: The development of antigen-targeted therapies may provide additional options to improve outcomes in children with acute myeloid leukemia (AML). The Children's Oncology Group AAML03P1 trial sought to determine the safety of adding 2 doses of gemtuzumab ozogamicin, a humanized anti-CD33 antibody-targeted agent, to intensive chemotherapy during remission induction and postremission intensification for children with de novo AML. METHODS: AAML03P1 enrolled 350 children with previously untreated AML. Patients with a matched family donor received 3 courses of chemotherapy followed by hematopoietic stem cell transplantation; those without a matched family donor received 5 courses of chemotherapy. Gemtuzumab ozogamicin 3 mg/m 2/dose was administered on Day 6 of Course 1 and Day 7 of Course 4. RESULTS: Toxicities observed in all courses of therapy were typical of AML chemotherapy regimens, with infection being most common. Patients achieved a complete remission rate of 83% after 1 course and 87% after 2 courses. The mortality rate was 1.5% after the first gemtuzumab ozogamicin-containing induction course and 2.6% after 2 induction courses. The 3-year event-free survival and overall survival rates were 53 ± 6% and 66 ± 5%, respectively. CONCLUSIONS: This trial determined that it is safe and feasible to include gemtuzumab ozogamicin in combination with intensive chemotherapy. The survival rates compare favorably with the recently published results of clinical trials worldwide.

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