Phase 3
Completed N=9,350
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
Acute Lymphoblastic Leukemia · Adult B Lymphoblastic Lymphoma · Ann Arbor Stage I B Lymphoblastic Lymphoma · Ann Arbor Stage II B Lymphoblastic Lymphoma
Source: ClinicalTrials.gov NCT01190930 ↗
Enrolled (actual)
9,350
Serious AEs
0.8%
Results posted
Jun 2020
Primary outcomePrimary: Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization — 95.05; 94.17 percent probability
◆ Published Evidence
Highly cited
102citations · ~20 / year
Excellent Outcomes With Reduced Frequency of Vincristine and Dexamethasone Pulses in Standard-Risk B-Lymphoblastic Leukemia: Results From Children's Oncology Group AALL0932.
Summary
This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
Linked Publications (4)
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Excellent Outcomes With Reduced Frequency of Vincristine and Dexamethasone Pulses in Standard-Risk B-Lymphoblastic Leukemia: Results From Children's Oncology Group AALL0932.
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Genomic Determinants of Outcome in Acute Lymphoblastic Leukemia.
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Outcomes in Children, Adolescents, and Young Adults With Down Syndrome and ALL: A Report From the Children's Oncology Group.
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Performance of Two-Phase Designs for the Time-to-Event Outcome and a Case Study Assessing the Relapse Risk Associated With B-ALL Subtypes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization |
95.05; 94.17 | — |
| PRIMARY DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization |
94.10; 95.13 | — |
| PRIMARY DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens |
98.75; 98.50 | — |
| PRIMARY DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care |
89.77 | — |
| PRIMARY Sample Collection of Central Path Review Slides in B-LLy Patients |
89.7 | — |
| PRIMARY Event Free Survival (EFS) for B-LLy Patients |
94.54 | — |
| PRIMARY Overall Survival (OS) for B-LLy Patients |
93.97 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional |
-1.21 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional |
-0.86 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional |
-0.84 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional |
-0.74 | — |
| SECONDARY Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional |
-0.62 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical |
-1.44 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical |
-0.59 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical |
-0.63 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical |
-0.66 | — |
| SECONDARY Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical |
-0.67 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School |
— | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School |
— | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School |
— | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School |
— | — |
| SECONDARY Burden of Therapy in Boy AR Patients Overall at End of Therapy: School |
— | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning |
-0.42 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning |
-0.19 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning |
-0.20 | — |
| SECONDARY Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning |
-0.30 | — |
| SECONDARY Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning |
-0.40 | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional |
-0.80; -0.89 | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional |
-0.72; -0.77 | — |
| SECONDARY Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional |
-0.71; -0.51 | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical |
-0.62; -0.64 | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical |
-0.64; -0.67 | — |
| SECONDARY Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical |
-0.85; -0.47 | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School |
— | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School |
— | — |
| SECONDARY Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School |
— | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning |
-0.16; -0.25 | — |
| SECONDARY Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning |
-0.27; -0.34 | — |
| SECONDARY Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning |
-0.46; -0.33 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right |
-0.87 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left |
-0.84 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right |
-0.39 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left |
-0.36 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right |
-0.27 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left |
-0.28 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right |
-1.12 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left |
-1.19 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right |
-1.12; -0.02 | — |
| SECONDARY Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left |
-1.19; 0.21 | — |
Eligibility Criteria
Inclusion Criteria
- B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932
- Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
- B-ALL patients must have an initial white blood cell count 25% blasts) marrow
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed their infants
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
Data sourced from ClinicalTrials.gov (NCT01190930) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.