Allogeneic SCT for CML, TKI Failure After TKI Failure

NCT02172365 | Unknown

• 1 other identifier: UHN 14-7493-AE
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will evaluate the outcomes of allogeneic stem cell transplantation which is the only curative treatment modality in the patients with chronic myeloid leukemia after failing tyrosine kinase inhibitor therapy. However, any update was not reported on the transplant outcomes in the patients failed TKI therapy, thus necessitating update of this data. Also, the European Group for Blood and Marrow Transplantation (EBMT) risk score is still of value, but insufficient numbers of patients have been transplanted in recent years and after TKI therapy to allow a robust reanalysis. Our study hypothesis is that allogeneic SCT treatment modality can rescue CML patients who failed TKI therapy due to resistance or to intolerance with improved survival and long-term outcomes. Also, another hypothesis will be examined if the EBMT risk score proposed pre-imatinib era can reproduce similar prognostic risk stratification of long-term outcomes in the patients treated with TKI.

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic myeloid leukemia; Allogeneic hematopoietic cell transplantation; Tyrosine kinase inhibitor; TKI failure

Outcome Measures

Primary Outcomes (1)

• Overall survival following allogeneic SCT for CML after TKI failure.

  Overall survival will be calculated from transplantation until the date of death from any cause or of latest follow-up

  at 3 years

Secondary Outcomes (2)

• Failure free survival following allogeneic SCT for CML after TKI failure

  at 3 years

• Relapse following allogeneic SCT for CML after TKI failure

  at 3 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with allogeneic stem cell transplantation (SCT) since 2000 till 2013 for any of tyrosine kinase inhibitor (TKI) failure due to resistance or intolerance during chronic myeloid leukemia (CML) management with tyrosine kinase inhibitor

You may qualify if:

• Patients treated with allogeneic stem cell transplantation (SCT) since 2000 till 2013 for any of tyrosine kinase inhibitor (TKI) failure due to resistance or intolerance during chronic myeloid leukemia (CML) management with tyrosine kinase inhibitor

You may not qualify if:

• Any CML patients not previously treated with TKI therapy prior to allogeneic stem cell treatment.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (5)

• Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Muller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saussele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM, Hehlmann R. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013 Aug 8;122(6):872-84. doi: 10.1182/blood-2013-05-501569. Epub 2013 Jun 26.

  PMID: 23803709 BACKGROUND

• Gratwohl A, Hermans J, Goldman JM, Arcese W, Carreras E, Devergie A, Frassoni F, Gahrton G, Kolb HJ, Niederwieser D, Ruutu T, Vernant JP, de Witte T, Apperley J. Risk assessment for patients with chronic myeloid leukaemia before allogeneic blood or marrow transplantation. Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation. Lancet. 1998 Oct 3;352(9134):1087-92. doi: 10.1016/s0140-6736(98)03030-x.

  PMID: 9798583 BACKGROUND

• Jabbour E, Cortes J, Santos FP, Jones D, O'Brien S, Rondon G, Popat U, Giralt S, Kebriaei P, Jones RB, Kantarjian H, Champlin R, de Lima M. Results of allogeneic hematopoietic stem cell transplantation for chronic myelogenous leukemia patients who failed tyrosine kinase inhibitors after developing BCR-ABL1 kinase domain mutations. Blood. 2011 Mar 31;117(13):3641-7. doi: 10.1182/blood-2010-08-302679. Epub 2010 Dec 14.

  PMID: 21156844 BACKGROUND

• Nicolini FE, Basak GW, Soverini S, Martinelli G, Mauro MJ, Muller MC, Hochhaus A, Chuah C, Dufva IH, Rege-Cambrin G, Saglio G, Michallet M, Labussiere H, Morisset S, Hayette S, Etienne G, Olavarria E, Zhou W, Peter S, Apperley JF, Cortes J. Allogeneic stem cell transplantation for patients harboring T315I BCR-ABL mutated leukemias. Blood. 2011 Nov 17;118(20):5697-700. doi: 10.1182/blood-2011-07-367326. Epub 2011 Sep 16.

  PMID: 21926354 BACKGROUND

• Saussele S, Lauseker M, Gratwohl A, Beelen DW, Bunjes D, Schwerdtfeger R, Kolb HJ, Ho AD, Falge C, Holler E, Schlimok G, Zander AR, Arnold R, Kanz L, Dengler R, Haferlach C, Schlegelberger B, Pfirrmann M, Muller MC, Schnittger S, Leitner A, Pletsch N, Hochhaus A, Hasford J, Hehlmann R; German CML Study Group. Allogeneic hematopoietic stem cell transplantation (allo SCT) for chronic myeloid leukemia in the imatinib era: evaluation of its impact within a subgroup of the randomized German CML Study IV. Blood. 2010 Mar 11;115(10):1880-5. doi: 10.1182/blood-2009-08-237115. Epub 2009 Nov 18.

  PMID: 19965667 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: March 1, 2014
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Locations

CA (1)