NCT02101853

Clinical Trial Information

Trial Number: NCT02101853 (ClinicalTrials.gov)

Disease Type:

Hematopoietic Neoplasm/Leukemia - Acute Lymphoblastic Leukemia

Trial Title:

Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Study ID:

AALL1331

Images are available?:

Is this a NCI-MATCH Trial?:

Datasets Linked to Trial

Title	Description
NCT02101853-D4	NCT02101853-D4: There are a total of 2 datasets associated with the PubMed 37257143: NCT02101853-D3 through NCT02101853-D4. This dataset, NCT02101853-D4, is required for providing specific incidence of adverse events of interest. Adverse events (AE) that occurred with a grade of 3 or above at a frequency of 5% or greater in at least one course of interest for the patients in the primary analysis are included. There are multiple rows per patient depending on the number of courses administered. Each column corresponds to a single AE event, either any grade or grade 3 or above. Additional data from the high and intermediate risk cohorts presented in PMID 33651090 can be found in NCT02101853-D1 and NCT02101853-D2.
NCT02101853-D3	NCT02101853-D3: There are a total of 2 datasets associated with the PubMed 37257143: NCT02101853-D3 through NCT02101853-D4. This dataset, NCT02101853-D3, provides the information for the consort diagram, baseline characteristics, relapse status, MRD (minimal residual disease) negativity, adverse event status in each course of interest, and primary outcome for the patients on AALL1331 as reported in the manuscript. There is one row for each patient enrolled. Additional data from the high and intermediate risk cohorts presented in PMID 33651090 can be found in NCT02101853-D1 and NCT02101853-D2,.

Title

Description

NCT02101853-D4

NCT02101853-D4: There are a total of 2 datasets associated with the PubMed 37257143: NCT02101853-D3 through NCT02101853-D4. This dataset, NCT02101853-D4, is required for providing specific incidence of adverse events of interest. Adverse events (AE) that occurred with a grade of 3 or above at a frequency of 5% or greater in at least one course of interest for the patients in the primary analysis are included. There are multiple rows per patient depending on the number of courses administered. Each column corresponds to a single AE event, either any grade or grade 3 or above. Additional data from the high and intermediate risk cohorts presented in PMID 33651090 can be found in NCT02101853-D1 and NCT02101853-D2.

NCT02101853-D3

NCT02101853-D3: There are a total of 2 datasets associated with the PubMed 37257143: NCT02101853-D3 through NCT02101853-D4. This dataset, NCT02101853-D3,
provides the information for the consort diagram, baseline characteristics, relapse status, MRD (minimal residual disease) negativity, adverse event status in each course of interest, and primary outcome for the patients on AALL1331 as reported in the manuscript. There is one row for each patient enrolled. Additional data from the high and intermediate risk cohorts presented in PMID 33651090 can be found in NCT02101853-D1 and NCT02101853-D2,.

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