NCT00557193

Clinical Trial Information


Trial Number: NCT00557193 (ClinicalTrials.gov)
Disease Type:
  • Hematopoietic Neoplasm/Leukemia - Acute Lymphoblastic Leukemia
Trial Title:
A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431, NSC#617807)
Study ID:
AALL0631
Images are available?:
No
Is this a NCI-MATCH Trial?:
No


Datasets Linked to Trial

Title Description
NCT00557193-D4 D4: NCT00557193-D4 Dataset Description:
There are 4 data submissions (NCT00557193-D1, -D2, -D3 and -D4) for PMID 33623141. This dataset, NCT00557193-D4, provides information of system organ class post-induction adverse events by treatment arm in supplemental Table 4.
NCT00557193-D3 D3: NCT00557193-D3 Dataset Description:
There are 3 data submissions (NCT00557193-D1, -D2 and -D3) for PMID 33623141. This dataset, NCT00557193-D3, provides the information of system organ class adverse event by treatment arm in Table 2.

NCT00557193-D2 D2: NCT00557193-D2 Dataset Description:
There are 3 data submissions (NCT00557193-D1, -D2 and -D3) for PMID 33623141. This dataset, NCT00557193-D2, provides the information of targeted adverse event by treatment arm in Table 2.
NCT00557193-D1 D1: NCT00557193-D1 Dataset Description:
There are 3 data submissions (NCT00557193-D1, -D2 and -D3) for PMID 33623141. This dataset, NCT00557193-D1, provides the information for generating Figure 1 of consort diagram of patient enrollment, information for generating Table 1 of KMT2A patient characteristics, information for Event-free survival /Disease-free survival / Overall survival analysis, Cumulative incidence of treatment failure, relapse and death, including Figure 2, 3, 4 , Table 4 and “Remission induction and treatment failure by risk group” section. It provides the information of Table 3 of Disease-free Events (Treatment failure, Relapse, and Death). There is one row for each patient enrolled. The data cutoff is 03/31/2019.