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Early-relapsing B-ALL
Source: Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 21, 2025 · Captured 2026-09-09.
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For B-ALL patients with an early marrow relapse, allogeneic transplant from an HLA-identical sibling or matched unrelated donor that is performed in second remission has been reported in most studies to result in higher leukemia-free survival (LFS) than a chemotherapy approach.[7,30,56-64] However, even with transplant, the survival rate for patients with early marrow relapse is less than 50%. One study analyzed 278 patients with early-relapsing B-ALL who were treated between 2001 and 2013 in trials conducted by either the ALL-REZ BFM or UK-ALL groups. The OS rate was 32.6%.[29] More favorable outcomes were observed for patients with early-relapsed B-ALL who had low end-reinduction MRD, low pre-HSCT MRD, and those who experienced acute GVHD. For more information, see the Hematopoietic Stem Cell Transplantation for First and Subsequent Bone Marrow Relapse section.
After initial reinduction chemotherapy, the use of blinatumomab instead of intensive cytotoxic chemotherapy as pre-HSCT consolidation has been shown to be associated with superior outcomes.[65,66]
Evidence (blinatumomab before HSCT in early-relapsing B-ALL):
In a randomized phase III trial conducted between 2015 and 2019, patients with early-relapsing B-ALL were randomly assigned to receive either one 28-day course of blinatumomab or a cycle of intensive cytotoxic chemotherapy as a third consolidation course before proceeding to HSCT. The study was intended to enroll 202 patients but was terminated early (after 108 patients enrolled) when the superiority of blinatumomab was demonstrated on the basis of a prespecified stopping rule.[65]
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In a randomized phase III trial conducted between 2015 and 2019, patients with early-relapsing B-ALL were randomly assigned to receive either one 28-day course of blinatumomab or a cycle of intensive cytotoxic chemotherapy as a third consolidation course before proceeding to HSCT. The study was intended to enroll 202 patients but was terminated early (after 108 patients enrolled) when the superiority of blinatumomab was demonstrated on the basis of a prespecified stopping rule.[65]
The 24-month EFS rate was 66.2% for patients who received blinatumomab, compared with 27.1% for patients who received the intensive chemotherapy block (hazard ratio [HR], 0.33; P < .001).
In a randomized phase III trial conducted between 2015 and 2019, patients with early-relapsing B-ALL were randomly assigned to receive either one 28-day course of blinatumomab or a cycle of intensive cytotoxic chemotherapy as a third consolidation course before proceeding to HSCT. The study was intended to enroll 202 patients but was terminated early (after 108 patients enrolled) when the superiority of blinatumomab was demonstrated on the basis of a prespecified stopping rule.[65]
The 24-month cumulative incidence of relapse was significantly lower in patients who received blinatumomab than in patients who received intensive chemotherapy (24.9% vs. 70.8%; HR, 0.24).
In a randomized phase III trial conducted between 2015 and 2019, patients with early-relapsing B-ALL were randomly assigned to receive either one 28-day course of blinatumomab or a cycle of intensive cytotoxic chemotherapy as a third consolidation course before proceeding to HSCT. The study was intended to enroll 202 patients but was terminated early (after 108 patients enrolled) when the superiority of blinatumomab was demonstrated on the basis of a prespecified stopping rule.[65]
For patients with high MRD (≥10-4) at the time randomized treatment began, more patients achieved MRD negativity with blinatumomab treatment than with intensive chemotherapy treatment (93% vs. 24%).
A COG phase III clinical trial compared two courses of blinatumomab with two blocks of intensive chemotherapy in patients with B-ALL in first relapse. Treatment randomization occurred after a single block of intensive reinduction chemotherapy. Eligible patients included those with early relapse or those with late relapse but MRD levels greater than 0.1% after reinduction chemotherapy. Study enrollment ended early because of loss of clinical equipoise, in favor of blinatumomab. This was determined by the study’s data and safety monitoring committee. Key findings from the trial include the following:[66]
Source links and citations
A COG phase III clinical trial compared two courses of blinatumomab with two blocks of intensive chemotherapy in patients with B-ALL in first relapse. Treatment randomization occurred after a single block of intensive reinduction chemotherapy. Eligible patients included those with early relapse or those with late relapse but MRD levels greater than 0.1% after reinduction chemotherapy. Study enrollment ended early because of loss of clinical equipoise, in favor of blinatumomab. This was determined by the study’s data and safety monitoring committee. Key findings from the trial include the following:[66]
The 2-year DFS rate was 54.4% for patients who received blinatumomab versus 39.0% for patients who received chemotherapy (HR for disease progression or mortality, 0.70; 95% confidence interval [CI], 0.47–1.03).
A COG phase III clinical trial compared two courses of blinatumomab with two blocks of intensive chemotherapy in patients with B-ALL in first relapse. Treatment randomization occurred after a single block of intensive reinduction chemotherapy. Eligible patients included those with early relapse or those with late relapse but MRD levels greater than 0.1% after reinduction chemotherapy. Study enrollment ended early because of loss of clinical equipoise, in favor of blinatumomab. This was determined by the study’s data and safety monitoring committee. Key findings from the trial include the following:[66]
The 2-year OS rate was 71.3% for patients who received blinatumomab versus 58.4% for patients who received chemotherapy (HR for mortality, 0.62; 95% CI, 0.39–0.98).
A COG phase III clinical trial compared two courses of blinatumomab with two blocks of intensive chemotherapy in patients with B-ALL in first relapse. Treatment randomization occurred after a single block of intensive reinduction chemotherapy. Eligible patients included those with early relapse or those with late relapse but MRD levels greater than 0.1% after reinduction chemotherapy. Study enrollment ended early because of loss of clinical equipoise, in favor of blinatumomab. This was determined by the study’s data and safety monitoring committee. Key findings from the trial include the following:[66]
Negative MRD rates were higher for patients after one or two courses of blinatumomab (75% and 66%, respectively) than for patients after one or two courses of intensive chemotherapy (32% and 32%, respectively).
A COG phase III clinical trial compared two courses of blinatumomab with two blocks of intensive chemotherapy in patients with B-ALL in first relapse. Treatment randomization occurred after a single block of intensive reinduction chemotherapy. Eligible patients included those with early relapse or those with late relapse but MRD levels greater than 0.1% after reinduction chemotherapy. Study enrollment ended early because of loss of clinical equipoise, in favor of blinatumomab. This was determined by the study’s data and safety monitoring committee. Key findings from the trial include the following:[66]
Adverse event rates for toxicities such as sepsis, mucositis, and febrile neutropenia were much lower for patients who received blinatumomab than for patients who received intensive chemotherapy.
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Preserved source evidence · Not medical advice