Acute Lymphoblastic Leukemia, in Relapse Clinical Trial
— FRENCH-CYTOOfficial title:
Efficacy and Toxicity of Blinatumomab in the French Compassionate Use Program (ATU) for Adult Patients With B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Refractory, in Relapse, or With Positive Minimal Residual Disease.
NCT number | NCT03751072 |
Other study ID # | FRENCH-CYTO |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 16, 2018 |
Est. completion date | January 30, 2019 |
The outcome of young adults (18-60 years) with ALL has been dramatically improved by the use
of pediatric-inspired trials. About 60% of these young adult patients will be cured at 5
years. In this context, early evaluation of minimal residual disease (MRD) at complete
remission has been shown to be one of the most powerful prognostic factor, but also
predictive of the benefit of allogeneic stem cell transplantation (ASCT). Despite this global
improvement, about 30% of patients experience a relapse and will be exposed to be refractory
to salvage therapy or to early disease escape. In adult ALL, the most important prognostic
factors at relapse are : the time from first CR to relapse, the achievement of a second
complete remission (CR), and the feasibility of ASCT.
Blinatumomab is a bispecific T-cell engager that recruits T-cell on CD19 positive blast cells
and induces anti-leukemic cytotoxicity. In a phase 3 trial in relapse/refractory
Philadelphia-negative (Ph-) ALL, 43% of patients achieved a CR or CR with partial
hematological recovery (CRh), with the majority of responses occurring within the first
cycle. In patients with positive MRD (MRD+) BCP-ALL, blinatumomab resulted in complete MRD
response in 78% of patients after one cycle.
Between 2012 and 2016, blinatumomab was available in France for R/R and MRD+ ALL adult
patients through the French Compassionate Use Program. About 92 adult ALL were treated at
different stages of the disease in 27 centers.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | January 30, 2019 |
Est. primary completion date | November 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patient with Philadelphia-negative or positive (Ph+) ALL in relapse, refractory to salvage therapy, or with MRD positive ALL that received blinatumomab in the French ATU program., - Patient treated in the GRAALL network, - Patient who does'nt object to participate in the study Exclusion Criteria : - none |
Country | Name | City | State |
---|---|---|---|
France | CABANNES-HAMY Aurélie | Paris |
Lead Sponsor | Collaborator |
---|---|
Group for Research in Adult Acute Lymphoblastic Leukemia | Amgen |
France,
Dhédin N, Huynh A, Maury S, Tabrizi R, Beldjord K, Asnafi V, Thomas X, Chevallier P, Nguyen S, Coiteux V, Bourhis JH, Hichri Y, Escoffre-Barbe M, Reman O, Graux C, Chalandon Y, Blaise D, Schanz U, Lhéritier V, Cahn JY, Dombret H, Ifrah N; GRAALL group. Role of allogeneic stem cell transplantation in adult patients with Ph-negative acute lymphoblastic leukemia. Blood. 2015 Apr 16;125(16):2486-96; quiz 2586. doi: 10.1182/blood-2014-09-599894. Epub 2015 Jan 13. — View Citation
Dombret H, Cluzeau T, Huguet F, Boissel N. Pediatric-like therapy for adults with ALL. Curr Hematol Malig Rep. 2014 Jun;9(2):158-64. doi: 10.1007/s11899-014-0210-9. Review. — View Citation
Gökbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Brüggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. — View Citation
Gökbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Hüttmann 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. Epub 2012 Apr 4. — View Citation
Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95. doi: 10.1182/blood-2014-05-552729. Epub 2014 May 29. Erratum in: Blood. 2015 Aug 20;126(8):1048. Dosage error in article text. — View Citation
Topp MS, Gökbuget N, Stein AS, Zugmaier G, O'Brien S, Bargou RC, Dombret H, Fielding AK, Heffner L, Larson RA, Neumann S, Foà R, Litzow M, Ribera JM, Rambaldi A, Schiller G, Brüggemann M, Horst HA, Holland C, Jia C, Maniar T, Huber B, Nagorsen D, Forman SJ, Kantarjian HM. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015 Jan;16(1):57-66. doi: 10.1016/S1470-2045(14)71170-2. Epub 2014 Dec 16. Erratum in: Lancet Oncol. 2015 Apr;16(4):e158. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival in R/R and MRD+ cohorts | Months | 6 months | |
Secondary | Response rates | Percent | 6 months | |
Secondary | Adverse events | Percent | 6 months | |
Secondary | Disease free survival | Months | 6 months |
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