B-precursor Acute Lymphoblastic LeukemiaBLINGNCT03123887
Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients With B-precursor ALL
An observational study of B-precursor Acute Lymphoblastic Leukemia, run by Harbin Hematology and Oncology Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- B-precursor Acute Lymphoblastic Leukemia
- What is being tested?
- salvage therapy
- How many people
- 632 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2015to 10 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Harbin Hematology Oncology
Harbin, Heilongjiang, 150000
About this study
Official title: 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)
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.
Read the detailed description
Title A Retrospective Study to Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients with Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (BLING)
Key Words Relapsed or refractory acute lymphoblastic leukemia, complete remission, duration of remission, overall survival, hematopoietic stem cell transplantation
Study Background and Rationale Although the response rate by first-line treatment has been improved, most adult patients with relapsed or refractory ALL will eventually relapse with poor outcome regardless of treatments. In order to improve the diagnosis and treatment level of adult ALL in China, Chinese Society of Hematology and Committee of Hematologic Malignancies of the Chinese Anti-Cancer Association released Expert Consensus on Diagnosis and Treatment of Acute Lymphoblastic Leukemia in Chinese Adult Patients in 2012. However, there is no nationwide multi-center retrospective observational study to evaluate the treatment status of adult patients with R/r ALL (including treatment regimens, and remission rate, overall survival and rate of allogeneic hematopoietic stem cell transplantation of R/r ALL patients following standard salvage chemotherapy), and these data will provide an important reference for further standardization of the treatment of ALL in China, improvement of the prognosis and the research and development of new drugs.
Study questions and Objectives
Primary objectives:
To estimate the proportion of patients in overall response rate (ORR) for early relapsed (a first remission duration of ≤12 months) or primary refractory R/r 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:
To estimate the proportion of patients in CR, CRh* or CRi for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment (CR/CRh*/CRi) To estimate overall survival (OS) for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment To estimate the duration of CR/CRh* for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment To estimate the duration of CR/CRh*/CRi for early relapsed/primary refractory Ph- B-precursor ALL patients following salvage treatment To estimate the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) among early relapsed/primary refractory Ph- B-precursor ALL patients following salvage treatment To examine the potential prognostic factors of early relapsed/primary refractory Ph-B-precursor ALL patients by performing subgroup and regression analyses To estimate overall response rate (CR/CRh*), CR/CRh*/CRi, overall survival (OS), duration of CR/CRh*/CRi, duration of CR/CRh* and the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) after CR or CRh* among Ph- B-precursor ALL patients with duration of first CR ≤ 12 months following first salvage treatment
Exploratory objectives:
To estimate the proportion of patients in CR/CRh*, duration of CR/CRh*, proportion of patients in CR/CRh*/CRi, duration of CR/CRh*/CRi, OS and proportion of patients receiving AlloHSCT following salvage treatment for late relapsed (a first remission duration of >12 months) Ph- B-precursor ALL To estimate the proportion of patients in CR/CRh*, duration of CR/CRh*, proportion of patients in CR/CRh*/CRi, duration of CR/CRh*/CRi, OS and the proportion of patients receiving AlloHSCT for Ph+ B-precursor ALL patients and specific subgroup of patients following treatment for R/r B-precursor ALL To examine the potential prognostic factors of late relapsed Ph- B-precursor ALL patients and Ph+ B-precursor ALL patients To describe the types of chemotherapy regimens received and the corresponding efficacy results of main regimens, among patients following primary and salvage treatment for R/r B-precursor ALL Study Design This study was a retrospective study in which data were retrospectively collected from patients with R/r B-precursor ALL in 14 main hematologic malignancy centers in China. Patient subgroups were defined by factors that might influence ORR and OS to better understand their effects on study endpoints.
Subjects and Study Size
The study selected patients with R/r B-precursor ALL meeting inclusion criteria. Specific inclusion criteria were as follows:
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, 2. No central nervous system involved at relapsed, 3. 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 allogeneic hematopoietic stem cell transplantation (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.
- Conditions
- B-precursor Acute Lymphoblastic Leukemia
- Being tested
- salvage therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salvage therapyOther
Also called Ph-PAS
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
| Study group | Role | What they receive |
|---|---|---|
| R/r B-precursor ALL | This study selected patients with Relapsed or Refractory (R/r) B-precursor Acute Lymphoblastic Leukemia Receives: Other: salvage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 years
Secondary outcomes (11)
proportion of patients in CR, CRh* or CRi
the proportion of patients in CR, CRh* or CRi for early relapsed/primary refractory Ph- B-precursor ALL patients following last salvage treatment
Measured: up to 3 years
overall survival
overall survival (OS) for early relapsed/primary refractory Ph- B-precursor ALL patients after CR or CRh* achieved
Measured: up to 3 years
duration of remission (CR/CRh*, CR/CRh*/CRi)
duration of remission (CR/CRh*, CR/CRh*/CRi) for early relapsed/primary refractory Ph- B-precursor ALL patients after CR or CRh* achieved
Measured: up to 3 years
proportion of patients receiving allogeneic hematopoietic stem cell transplantation
the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) among early relapsed/primary refractory Ph- B-precursor ALL patients following salvage treatment
Measured: up to 3 years
overall survival
overall survival (OS) among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy
Measured: up to 3 years
duration of CR/CRh*/CRi
duration of CR/CRh* among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy
Measured: up to 3 years
the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT)
the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) after CR or CRh* achieved among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy
Measured: up to 3 years
Complete Response
Complete Response among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy
Measured: up to 3 years
Complete Response with incomplete recovery of blood cells
Complete Response with incomplete recovery of blood cells among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy
Measured: up to 3 years
Complete Response with partial recovery of blood cells
Complete Response with partial recovery of blood cells among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy
Measured: up to 3 years
duration of CR/CRh*
duration of CR/CRh* with partial recovery of blood cells among R/r Ph- B-precursor ALL patients after achieving CR or CRh* after the first salvage therapy
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start10 Jul 2015
- Primary completion3 Jun 2016
- Study completion10 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for B-precursor Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Hematology and Oncology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, Harbin Hematology and Oncology Institute
- Investigators
- Jun Ma, director, Study chair, Institute of Harbin Hematology Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123887
- Sponsor's protocol ID
- TA-ALL-150182
- Acronym
- BLING
- Status last verified
- Apr 2017
- First submitted
- 13 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: To protect the privacy of individual who participate in this trial we would not share the individual data with other researchers
Publications
Bassan 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.
PubMed 15182827Fielding 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.
PubMed 17032921Gokbuget 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.
PubMed 22493293Jabbour EJ, Faderl S, Kantarjian HM. Adult acute lymphoblastic leukemia. Mayo Clin Proc. 2005 Nov;80(11):1517-27. doi: 10.4065/80.11.1517.
PubMed 16295033Larson 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.
PubMed 16304370Le 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.
PubMed 17407135Liu L, Jiao W, Zhang Y, Qu Q, Li X, Wu D. Efficacy of low-dose cytarabine and aclarubicin in combination with granulocyte colony-stimulating factor (CAG regimen) compared to Hyper-CVAD regimen as salvage chemotherapy in relapsed/refractory Philadelphia chromosome-negative acute lymphoblastic leukemia. Leuk Res. 2015 Mar;39(3):323-8. doi: 10.1016/j.leukres.2015.01.003. Epub 2015 Jan 16.
PubMed 25638269Oriol A, Vives S, Hernandez-Rivas JM, Tormo M, Heras I, Rivas C, Bethencourt C, Moscardo F, Bueno J, Grande C, del Potro E, Guardia R, Brunet S, Bergua J, Bernal T, Moreno MJ, Calvo C, Bastida P, Feliu E, Ribera JM; Programa Espanol de Tratamiento en Hematologia Group. Outcome after relapse of acute lymphoblastic leukemia in adult patients included in four consecutive risk-adapted trials by the PETHEMA Study Group. Haematologica. 2010 Apr;95(4):589-96. doi: 10.3324/haematol.2009.014274. Epub 2010 Feb 9.
PubMed 20145276Pui CH, Evans WE. Acute lymphoblastic leukemia. N Engl J Med. 1998 Aug 27;339(9):605-15. doi: 10.1056/NEJM199808273390907. No abstract available.
PubMed 9718381Thomas 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.
PubMed 10506707Yan 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.
PubMed 23837640
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03123887
- Acronym / sponsor ID
- BLING / TA-ALL-150182
- Conditions
- B-precursor Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Harbin Hematology and Oncology InstituteUniversity, hospital or other
- Study start
- 10 Jul 2015 (actual)
- Primary completion
- 3 Jun 2016 (actual)
- Study completion
- 10 Oct 2016 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title A Retrospective Study to Evaluate the Hematological Remission Rates and Survival Among Chinese Adult Patients with Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia (BLING)
Key Words Relapsed or refractory acute lymphoblastic leukemia, complete remission, duration of remission, overall survival, hematopoietic stem cell transplantation
Study Background and Rationale Although the response rate by first-line treatment has been improved, most adult patients with relapsed or refractory ALL will eventually relapse with poor outcome regardless of treatments. In order to improve the diagnosis and treatment level of adult ALL in China, Chinese Society of Hematology and Committee of Hematologic Malignancies of the Chinese Anti-Cancer Association released Expert Consensus on Diagnosis and Treatment of Acute Lymphoblastic Leukemia in Chinese Adult Patients in 2012. However, there is no nationwide multi-center retrospective observational study to evaluate the treatment status of adult patients with R/r ALL (including treatment regimens, and remission rate, overall survival and rate of allogeneic hematopoietic stem cell transplantation of R/r ALL patients following standard salvage chemotherapy), and these data will provide an important reference for further standardization of the treatment of ALL in China, improvement of the prognosis and the research and development of new drugs.
Study questions and Objectives
Primary objectives:
To estimate the proportion of patients in overall response rate (ORR) for early relapsed (a first remission duration of ≤12 months) or primary refractory R/r 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:
To estimate the proportion of patients in CR, CRh* or CRi for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment (CR/CRh*/CRi) To estimate overall survival (OS) for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment To estimate the duration of CR/CRh* for early relapsed/primary refractory Ph-B-precursor ALL patients following salvage treatment To estimate the duration of CR/CRh*/CRi for early relapsed/primary refractory Ph- B-precursor ALL patients following salvage treatment To estimate the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) among early relapsed/primary refractory Ph- B-precursor ALL patients following salvage treatment To examine the potential prognostic factors of early relapsed/primary refractory Ph-B-precursor ALL patients by performing subgroup and regression analyses To estimate overall response rate (CR/CRh*), CR/CRh*/CRi, overall survival (OS), duration of CR/CRh*/CRi, duration of CR/CRh* and the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT) after CR or CRh* among Ph- B-precursor ALL patients with duration of first CR ≤ 12 months following first salvage treatment
Exploratory objectives:
To estimate the proportion of patients in CR/CRh*, duration of CR/CRh*, proportion of patients in CR/CRh*/CRi, duration of CR/CRh*/CRi, OS and proportion of patients receiving AlloHSCT following salvage treatment for late relapsed (a first remission duration of >12 months) Ph- B-precursor ALL To estimate the proportion of patients in CR/CRh*, duration of CR/CRh*, proportion of patients in CR/CRh*/CRi, duration of CR/CRh*/CRi, OS and the proportion of patients receiving AlloHSCT for Ph+ B-precursor ALL patients and specific subgroup of patients following treatment for R/r B-precursor ALL To examine the potential prognostic factors of late relapsed Ph- B-precursor ALL patients and Ph+ B-precursor ALL patients To describe the types of chemotherapy regimens received and the corresponding efficacy results of main regimens, among patients following primary and salvage treatment for R/r B-precursor ALL Study Design This study was a retrospective study in which data were retrospectively collected from patients with R/r B-precursor ALL in 14 main hematologic malignancy centers in China. Patient subgroups were defined by factors that might influence ORR and OS to better understand their effects on study endpoints.
Subjects and Study Size
The study selected patients with R/r B-precursor ALL meeting inclusion criteria. Specific inclusion criteria were as follows:
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, 2. No central nervous system involved at relapsed, 3. 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 allogeneic hematopoietic stem cell transplantation (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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R/r B-precursor ALL | – | Other: salvage therapyThis study selected patients with Relapsed or Refractory (R/r) B-precursor Acute Lymphoblastic Leukemia |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salvage therapyAlso: Ph-PASVDC(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 | Other | R/r B-precursor ALL |
Primary outcome
overall response rate
Time frame: up to 3 years
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
11 secondary outcomes
proportion of patients in CR, CRh* or CRi
Time frame: up to 3 years
overall survival
Time frame: up to 3 years
duration of remission (CR/CRh*, CR/CRh*/CRi)
Time frame: up to 3 years
proportion of patients receiving allogeneic hematopoietic stem cell transplantation
Time frame: up to 3 years
overall survival
Time frame: up to 3 years
duration of CR/CRh*/CRi
Time frame: up to 3 years
the proportion of patients receiving allogeneic hematopoietic stem cell transplantation (AlloHSCT)
Time frame: up to 3 years
Complete Response
Time frame: up to 3 years
Complete Response with incomplete recovery of blood cells
Time frame: up to 3 years
Complete Response with partial recovery of blood cells
Time frame: up to 3 years
duration of CR/CRh*
Time frame: up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Background: PubMed 15182827Bassan 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.
- Background: PubMed 17032921Fielding 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.
- Background: PubMed 22493293Gokbuget 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.
- Background: PubMed 16295033Jabbour EJ, Faderl S, Kantarjian HM. Adult acute lymphoblastic leukemia. Mayo Clin Proc. 2005 Nov;80(11):1517-27. doi: 10.4065/80.11.1517.
- Background: PubMed 16304370Larson 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.
- Background: PubMed 17407135Le 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.
- Background: PubMed 25638269Liu L, Jiao W, Zhang Y, Qu Q, Li X, Wu D. Efficacy of low-dose cytarabine and aclarubicin in combination with granulocyte colony-stimulating factor (CAG regimen) compared to Hyper-CVAD regimen as salvage chemotherapy in relapsed/refractory Philadelphia chromosome-negative acute lymphoblastic leukemia. Leuk Res. 2015 Mar;39(3):323-8. doi: 10.1016/j.leukres.2015.01.003. Epub 2015 Jan 16.
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- Background: PubMed 10506707Thomas 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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- Individual participant dataSharing planned: No. To protect the privacy of individual who participate in this trial we would not share the individual data with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ma, director study chair
Institute of Harbin Hematology Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-precursor Acute Lymphoblastic Leukemia, run by Harbin Hematology and Oncology Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123887, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.