CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 632 enrolled
Drug / intervention
salvage therapyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03123887
NCT03123887N/ACompleted

A Retrospective Study to Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia(ALL)

Harbin Hematology and Oncology Institute·observational·Posted Apr 21, 2017·Updated Apr 21, 2017

In Brief

An observational study evaluating salvage therapy for B-precursor Acute Lymphoblastic Leukemia. Completed, enrolled 632 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 21, 2017
Enrollment StartJul 10, 2015
Primary CompletionJun 3, 2016
Study CompletionOct 10, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.2 years ago

Interventions

salvage therapyother

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