Originally published as JCO Early Release 10.1200/JCO.2005.04.5856 on May 22 2006

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Bone Marrow Transplantation Versus Prolonged Intensive Chemotherapy for Children With Acute Lymphoblastic Leukemia and an Initial Bone Marrow Relapse Within 12 Months of the Completion of Primary Therapy: Children's Oncology Group Study CCG-1941

Paul S. Gaynon, Richard E. Harris, Arnold J. Altman, Bruce C. Bostrom, John C. Breneman, Ria Hawks, David Steele, Theodore Zipf, Daniel O. Stram, Doodjuen Villaluna, Michael E. Trigg

From the Division of Hematology-Oncology, Children’s Hospital Los Angeles, Los Angeles, CA; Bone Marrow Transplant Program and Division of Radiation Oncology, Children’s Hospital Medical Center Cincinnati, Cincinnati, OH; Department of Hematology-Oncology, Connecticut Children's Medical Center, Hartford, CT; Department of Pediatric Hematology/Oncology, Children’s Hospital and Clinics Minneapolis and St Paul, Minneapolis, MN; Department of Pediatric Oncology, Columbia Presbyterian College of Physicians and Surgeons, New York, NY; Northampton Area Pediatrics, Northampton, MA; Division of Pediatrics, M.D. Anderson Cancer Center, Houston, TX; Department of Statistics, Children's Oncology Group, Arcadia, CA; and the Alfred I. DuPont Hospital for Children, Wilmington, DE

Address reprint requests to Paul S. Gaynon, MD, Children's Oncology Group Publications Office, 440 E Huntington Dr, PO Box 60012, Arcadia, CA 91066-6012; e-mail: PGaynon{at}chla.usc.edu; CC: pubs{at}childrensoncologygroup.org

PURPOSE: To compare conventional sibling bone marrow transplantation (CBMT), BMT with alternative donor (ABMT), and chemotherapy (CT) for children with acute lymphoblastic leukemia (ALL) and an early first marrow relapse.

PATIENTS AND METHODS: After informed consent, 214 patients with ALL and early marrow relapse began multiagent induction therapy. One hundred sixty-three patients with fewer than 25% marrow blasts and count recovery at the end of induction (second remission [CR2]) were allocated by donor availability. Fifty patients with sibling donors were allocated to CBMT. Seventy-two patients were randomly allocated between ABMT and CT while 41 patients refused allocation.

RESULTS: Overall, 3-year event free survival from entry is 19% ± 3%. Thirty-two of 50 CBMT patients (64%) and 19 of 37 ABMT patients (51%) underwent transplantation in CR2 with 3-year disease-free survival of 42% ± 7% and 29% ± 7%. The 3-year DFS is 29% ± 7%, 21% ± 7%, and 27% ± 8% for patients allocated to CBMT, ABMT, and CT, respectively. Contrary to protocol, 12 of 35 patients allocated to CT underwent BMT in CR2. Of these, five patients died after BMT and 5 patients relapsed.

CONCLUSION: More than one half of patients died, failed reinduction, or relapsed again before 3 months after CR2 (median time to BMT). Intent-to-treat pair-wise comparison of ABMT with CT, CT with CBMT, and CBMT with ABMT yields hazards of 1.2, 1.1, 0.8 with P values of .56, .80, and .36, respectively. Outcomes remain similar and poor for children with ALL and early marrow relapse. BMT is not a complete answer to the challenge of ALL and early marrow relapse.

A complete listing of grant support for research conducted by Children's Cancer Group and Pediatric Oncology Group before initiation of the Children's Oncology Group grant in 2003 is available online at http://www.childrensoncologygroup.org/admin/grantinfo.htm.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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