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

NCT03123887 | Completed FDA Drug FDA Device

• 1 other identifier: TA-ALL-150182
• Study Type: observational
• Target: 632
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• overall response rate

  overall response rate after the last salvage therapy, i.e., CR/CRh\*. CR is generally defined as no blasts in peripheral blood, absence of extramedullary leukemia, full recovery of peripheral blood counts, ≤ 5% blasts in the bone marrow, ANC \> 1.0×109/L, PLT \> 100×109/L, no relapse within 4 weeks. CRh\* was CR with partial recovery of peripheral blood counts, ANC \> 0.5×109/L, PLT \> 50×109/L, with other conditions meeting the criteria for CR

  up to 3 years

Secondary Outcomes (11)

• proportion of patients in CR, CRh* or CRi

  up to 3 years

• overall survival

  up to 3 years

• duration of remission (CR/CRh*, CR/CRh*/CRi)

  up to 3 years

• proportion of patients receiving allogeneic hematopoietic stem cell transplantation

  up to 3 years

• overall survival

  up to 3 years

Study Arms (1)

R/r B-precursor ALL

This study selected patients with Relapsed or Refractory (R/r) B-precursor Acute Lymphoblastic Leukemia

Other: salvage therapy

Interventions

salvage therapy OTHER

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

Also known as: Ph-PAS

R/r B-precursor ALL

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia

You may qualify if:

• Chinese adult patients with R/r B-precursor ALL who had received salvage treatment
• At least one complete response evaluation results available for salvage treatment
• With definite Ph chromosome status
• Age ≥15 years at time of de novo (initial) diagnosis of ALL.
• For relapsed patients who met the above conditions must also have
• Evaluable duration of CR by initial therapy
• No central nervous system involved at relapsed
• No isolated extramedullary relapse Patients were divided into 3 analysis sets based on molecular genetic factor and type, and time from initial response to relapse.
• Ph- Primary Analysis Set included patients who are diagnosed with Ph- disease and meet one of the following criteria:
• in first relapse or salvage treatment after a first complete remission duration of ≤12 months, or refractory to initial treatment, or relapsed/refractory after first or subsequent salvage treatment, or Relapsed/refractory within 12 months after alloHSCT.
• The Ph- Late Relapse Analysis Set included patients who had a first remission duration of \>12 months and were in first relapse or salvage treatment.
• The Ph+ Analysis Set included patients who were diagnosed with Ph+ disease.

Sponsors & Collaborators

• Harbin Hematology and Oncology Institute: lead

Study Sites (1)

Institute of Harbin Hematology Oncology

Harbin, Heilongjiang, 150000, China

Location

Related Publications (11)

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  PMID: 22493293 BACKGROUND

• Jabbour EJ, Faderl S, Kantarjian HM. Adult acute lymphoblastic leukemia. Mayo Clin Proc. 2005 Nov;80(11):1517-27. doi: 10.4065/80.11.1517.

  PMID: 16295033 BACKGROUND

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  PMID: 25638269 BACKGROUND

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• Pui CH, Evans WE. Acute lymphoblastic leukemia. N Engl J Med. 1998 Aug 27;339(9):605-15. doi: 10.1056/NEJM199808273390907. No abstract available.

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• Thomas DA, Kantarjian H, Smith TL, Koller C, Cortes J, O'Brien S, Giles FJ, Gajewski J, Pierce S, Keating MJ. Primary refractory and relapsed adult acute lymphoblastic leukemia: characteristics, treatment results, and prognosis with salvage therapy. Cancer. 1999 Oct 1;86(7):1216-30. doi: 10.1002/(sici)1097-0142(19991001)86:73.0.co;2-o.

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• Yan CH, Wang JZ, Liu DH, Xu LP, Chen H, Liu KY, Huang XJ. Chemotherapy followed by modified donor lymphocyte infusion as a treatment for relapsed acute leukemia after haploidentical hematopoietic stem cell transplantation without in vitro T-cell depletion: superior outcomes compared with chemotherapy alone and an analysis of prognostic factors. Eur J Haematol. 2013 Oct;91(4):304-14. doi: 10.1111/ejh.12168. Epub 2013 Aug 17.

  PMID: 23837640 BACKGROUND

MeSH Terms

Interventions

Salvage Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jun Ma, director

  Institute of Harbin Hematology Oncology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of department of Hematology and Oncology

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 21, 2017
• Study Start: July 10, 2015
• Primary Completion: June 3, 2016
• Study Completion: October 10, 2016
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)