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Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With B-precursor ALL

NCT03123887 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 632

Last updated 2017-04-21

No results posted yet for this study

Summary

Although the response rate by first-line treatment has been improved, most adult patients with relapsed or refractory ALL will eventually relapse with poor outcomes regardless of treatments. To further understand current status of the treatment of adult patients with relapsed or refractory ALL in China, the study retrospectively collected diagnosis and treatment data from ALL patients in 14 centers in China. Primary objective: to estimate the proportion of patients in overall response rate (ORR) for early relapsed or primary refractory Philadelphia chromosome negative (Ph-) B-precursor ALL patients following salvage treatment (i.e., proportion of patients in hematological complete remission \[CR\] and CR with partial recovery of blood cells \[CRh\*\]); Secondary objectives included: to estimate the proportion of patients in CR, CRh\* and CRi(CR/CRh\*/CRi) and the duration of CR/CRh\*/CRi, overall survival, duration of CR/CRh\*and the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment; Exploratory objectives included: to estimate the efficacy in late relapsed Ph- B-precursor ALL (first remission duration \> 12 months) patients and in Ph+ B-precursor ALL patients and specific subgroup patients following salvage treatment.

Conditions

  • B-precursor Acute Lymphoblastic Leukemia

Interventions

OTHER

salvage therapy

VDC(L)P regimen or High-dose cytarabine based regimen or High-dose methotrexate based regimen or Hyper-CVAD regimen or FLAG (Flu, Ara-C, G-CSF) ± anthracyclines based regimen or Repeated original induction regimen or VDP or other

Sponsors & Collaborators

  • Harbin Hematology and Oncology Institute

    lead OTHER

Principal Investigators

  • Jun Ma, director · Institute of Harbin Hematology Oncology

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-10
Primary Completion
2016-06-03
Completion
2016-10-10
FDA Drug
Yes
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123887 on ClinicalTrials.gov