Clinical trial · Observational
Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With B-precursor ALL
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-precursor Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| salvage therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- R/r B-precursor ALL
- description
- This study selected patients with Relapsed or Refractory (R/r) B-precursor Acute Lymphoblastic Leukemia
- interventionNames
- Other: salvage therapy
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- up to 3 years
- description
- 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
Secondary outcomes (11)
- measure
- proportion of patients in CR, CRh* or CRi
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: \-
References
Publications (11)
- BACKGROUNDBassan R, Gatta G, Tondini C, Willemze R. Adult acute lymphoblastic leukaemia. Crit Rev Oncol Hematol. 2004 Jun;50(3):223-61. doi: 10.1016/j.critrevonc.2003.11.003. PMID 15182827
- BACKGROUNDFielding AK, Richards SM, Chopra R, Lazarus HM, Litzow MR, Buck G, Durrant IJ, Luger SM, Marks DI, Franklin IM, McMillan AK, Tallman MS, Rowe JM, Goldstone AH; Medical Research Council of the United Kingdom Adult ALL Working Party; Eastern Cooperative Oncology Group. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2007 Feb 1;109(3):944-50. doi: 10.1182/blood-2006-05-018192. Epub 2006 Oct 10. PMID 17032921
- BACKGROUNDGokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4. PMID 22493293
- BACKGROUNDJabbour 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
- BACKGROUNDLarson RA. Acute lymphoblastic leukemia: older patients and newer drugs. Hematology Am Soc Hematol Educ Program. 2005:131-6. doi: 10.1182/asheducation-2005.1.131. PMID 16304370
- BACKGROUNDLe QH, Thomas X, Ecochard R, Iwaz J, Lheritier V, Michallet M, Fiere D. Proportion of long-term event-free survivors and lifetime of adult patients not cured after a standard acute lymphoblastic leukemia therapeutic program: adult acute lymphoblastic leukemia-94 trial. Cancer. 2007 May 15;109(10):2058-67. doi: 10.1002/cncr.22632.