Re-induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL): Phase II results from Children's Oncology Group (COG) study ADVL04P2

Elizabeth A. Raetz, Mitchell S. Cairo, Michael J. Borowitz, Xiaomin Lu, Meenakshi Devidas, Joel M Reid, David M. Goldenberg, William A. Wegener, Hui Zeng, James A. Whitlock, Peter C. Adamson, Stephen P. Hunger, William L. Carroll

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

Background: Given the success of immunotherapeutic approaches in hematologic malignancies, the COG designed a phase I/II study to determine whether the addition of epratuzumab (anti-CD22) to an established chemotherapy platform improves rates of second remission (CR2) in pediatric patients with B-lymphoblastic leukemia (B-ALL) and early bone marrow relapse. Procedure: Therapy consisted of three established blocks of re-induction chemotherapy. Epratuzumab (360mg/m<sup>2</sup>/dose) was combined with chemotherapy on weekly×4 (B1) and twice weekly×4 [eight doses] (B2) schedules during the first re-induction block. Remission rates and minimal residual disease (MRD) status were compared to historical rates observed with the identical chemotherapy platform alone. Results: CR2 was achieved in 65 and 66%, of the evaluable B1 (n=54) and B2 patients (n=60), respectively; unchanged from that observed historically without epratuzumab. Rates of MRD negativity (<0.01%) were 31% in B1 (P=0.4128) and 39% in B2 patients (P=0.1731), compared to 25% in historical controls. The addition of epratuzumab was well tolerated, with a similar toxicity profile to that observed with the re-induction chemotherapy platform regimen alone. Conclusions: Epratuzumab was well tolerated in combination with re-induction chemotherapy. While CR2 rates were not improved compared to historical controls treated with chemotherapy alone, there was a non-significant trend towards improvement in MRD response with the addition of epratuzumab (twice weekly for eight doses) to re-induction chemotherapy. Pediatr Blood Cancer 2015;62:1171-1175.

Original languageEnglish (US)
Pages (from-to)1171-1175
Number of pages5
JournalPediatric Blood and Cancer
Volume62
Issue number7
DOIs
StatePublished - Jul 1 2015

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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Induction Chemotherapy
Residual Neoplasm
Drug Therapy
Hematologic Neoplasms
epratuzumab
Appointments and Schedules
Bone Marrow
Pediatrics
Recurrence
Neoplasms

Keywords

  • Epratuzumab
  • Monoclonal antibody
  • Relapsed ALL

ASJC Scopus subject areas

  • Oncology
  • Pediatrics, Perinatology, and Child Health
  • Hematology

Cite this

Re-induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL) : Phase II results from Children's Oncology Group (COG) study ADVL04P2. / Raetz, Elizabeth A.; Cairo, Mitchell S.; Borowitz, Michael J.; Lu, Xiaomin; Devidas, Meenakshi; Reid, Joel M; Goldenberg, David M.; Wegener, William A.; Zeng, Hui; Whitlock, James A.; Adamson, Peter C.; Hunger, Stephen P.; Carroll, William L.

In: Pediatric Blood and Cancer, Vol. 62, No. 7, 01.07.2015, p. 1171-1175.

Research output: Contribution to journalArticle

Raetz, EA, Cairo, MS, Borowitz, MJ, Lu, X, Devidas, M, Reid, JM, Goldenberg, DM, Wegener, WA, Zeng, H, Whitlock, JA, Adamson, PC, Hunger, SP & Carroll, WL 2015, 'Re-induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL): Phase II results from Children's Oncology Group (COG) study ADVL04P2', Pediatric Blood and Cancer, vol. 62, no. 7, pp. 1171-1175. https://doi.org/10.1002/pbc.25454
Raetz, Elizabeth A. ; Cairo, Mitchell S. ; Borowitz, Michael J. ; Lu, Xiaomin ; Devidas, Meenakshi ; Reid, Joel M ; Goldenberg, David M. ; Wegener, William A. ; Zeng, Hui ; Whitlock, James A. ; Adamson, Peter C. ; Hunger, Stephen P. ; Carroll, William L. / Re-induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL) : Phase II results from Children's Oncology Group (COG) study ADVL04P2. In: Pediatric Blood and Cancer. 2015 ; Vol. 62, No. 7. pp. 1171-1175.
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abstract = "Background: Given the success of immunotherapeutic approaches in hematologic malignancies, the COG designed a phase I/II study to determine whether the addition of epratuzumab (anti-CD22) to an established chemotherapy platform improves rates of second remission (CR2) in pediatric patients with B-lymphoblastic leukemia (B-ALL) and early bone marrow relapse. Procedure: Therapy consisted of three established blocks of re-induction chemotherapy. Epratuzumab (360mg/m2/dose) was combined with chemotherapy on weekly×4 (B1) and twice weekly×4 [eight doses] (B2) schedules during the first re-induction block. Remission rates and minimal residual disease (MRD) status were compared to historical rates observed with the identical chemotherapy platform alone. Results: CR2 was achieved in 65 and 66{\%}, of the evaluable B1 (n=54) and B2 patients (n=60), respectively; unchanged from that observed historically without epratuzumab. Rates of MRD negativity (<0.01{\%}) were 31{\%} in B1 (P=0.4128) and 39{\%} in B2 patients (P=0.1731), compared to 25{\%} in historical controls. The addition of epratuzumab was well tolerated, with a similar toxicity profile to that observed with the re-induction chemotherapy platform regimen alone. Conclusions: Epratuzumab was well tolerated in combination with re-induction chemotherapy. While CR2 rates were not improved compared to historical controls treated with chemotherapy alone, there was a non-significant trend towards improvement in MRD response with the addition of epratuzumab (twice weekly for eight doses) to re-induction chemotherapy. Pediatr Blood Cancer 2015;62:1171-1175.",
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T1 - Re-induction chemoimmunotherapy with epratuzumab in relapsed acute lymphoblastic leukemia (ALL)

T2 - Phase II results from Children's Oncology Group (COG) study ADVL04P2

AU - Raetz, Elizabeth A.

AU - Cairo, Mitchell S.

AU - Borowitz, Michael J.

AU - Lu, Xiaomin

AU - Devidas, Meenakshi

AU - Reid, Joel M

AU - Goldenberg, David M.

AU - Wegener, William A.

AU - Zeng, Hui

AU - Whitlock, James A.

AU - Adamson, Peter C.

AU - Hunger, Stephen P.

AU - Carroll, William L.

PY - 2015/7/1

Y1 - 2015/7/1

N2 - Background: Given the success of immunotherapeutic approaches in hematologic malignancies, the COG designed a phase I/II study to determine whether the addition of epratuzumab (anti-CD22) to an established chemotherapy platform improves rates of second remission (CR2) in pediatric patients with B-lymphoblastic leukemia (B-ALL) and early bone marrow relapse. Procedure: Therapy consisted of three established blocks of re-induction chemotherapy. Epratuzumab (360mg/m2/dose) was combined with chemotherapy on weekly×4 (B1) and twice weekly×4 [eight doses] (B2) schedules during the first re-induction block. Remission rates and minimal residual disease (MRD) status were compared to historical rates observed with the identical chemotherapy platform alone. Results: CR2 was achieved in 65 and 66%, of the evaluable B1 (n=54) and B2 patients (n=60), respectively; unchanged from that observed historically without epratuzumab. Rates of MRD negativity (<0.01%) were 31% in B1 (P=0.4128) and 39% in B2 patients (P=0.1731), compared to 25% in historical controls. The addition of epratuzumab was well tolerated, with a similar toxicity profile to that observed with the re-induction chemotherapy platform regimen alone. Conclusions: Epratuzumab was well tolerated in combination with re-induction chemotherapy. While CR2 rates were not improved compared to historical controls treated with chemotherapy alone, there was a non-significant trend towards improvement in MRD response with the addition of epratuzumab (twice weekly for eight doses) to re-induction chemotherapy. Pediatr Blood Cancer 2015;62:1171-1175.

AB - Background: Given the success of immunotherapeutic approaches in hematologic malignancies, the COG designed a phase I/II study to determine whether the addition of epratuzumab (anti-CD22) to an established chemotherapy platform improves rates of second remission (CR2) in pediatric patients with B-lymphoblastic leukemia (B-ALL) and early bone marrow relapse. Procedure: Therapy consisted of three established blocks of re-induction chemotherapy. Epratuzumab (360mg/m2/dose) was combined with chemotherapy on weekly×4 (B1) and twice weekly×4 [eight doses] (B2) schedules during the first re-induction block. Remission rates and minimal residual disease (MRD) status were compared to historical rates observed with the identical chemotherapy platform alone. Results: CR2 was achieved in 65 and 66%, of the evaluable B1 (n=54) and B2 patients (n=60), respectively; unchanged from that observed historically without epratuzumab. Rates of MRD negativity (<0.01%) were 31% in B1 (P=0.4128) and 39% in B2 patients (P=0.1731), compared to 25% in historical controls. The addition of epratuzumab was well tolerated, with a similar toxicity profile to that observed with the re-induction chemotherapy platform regimen alone. Conclusions: Epratuzumab was well tolerated in combination with re-induction chemotherapy. While CR2 rates were not improved compared to historical controls treated with chemotherapy alone, there was a non-significant trend towards improvement in MRD response with the addition of epratuzumab (twice weekly for eight doses) to re-induction chemotherapy. Pediatr Blood Cancer 2015;62:1171-1175.

KW - Epratuzumab

KW - Monoclonal antibody

KW - Relapsed ALL

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