Prophylactic Transfer of Leukemia-reactive T Cells After Allogeneic Transplantation

NCT00460629 | Completed Phase 1

• 1 other identifier: EK126092000
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Efforts to decrease the risk of GvHD by depleting T cells from the graft in CML patients have been complicated by an increased incidence of leukemia-relapse. Newer protocols using CD34+ selected hematopoietic cells from matched-sibling donors and subsequent infusion of T cells in incremental doses to treat or avoid relapse of disease seem to be more promising. In this study, we try to further optimize this approach by the prophylactic infusion of cytotoxic T cells activated ex-vivo against leukemia-associated/specific antigens using peptide-pulsed dendritic cells.

Conditions

Chronic Myeloid Leukemia

Keywords

Adoptive immunotherapy; BCR-ABL reactive T cells; Allogeneic Transplantation

Outcome Measures

Primary Outcomes (2)

• Feasibility of the infusion of in-vitro activated donor T cells

  5 years

• kinetic of BCR-ABL load after transplantation

  5 years

Secondary Outcomes (2)

• Rate of acute and chronic GvHD

  3 years

• Rate of infectious complications

  2 years

Interventions

Application of activated donor T cells PROCEDURE

Ex-vivo generated donor T cells stimulated by antigen presenting cells loaded with peptides derived from leukemia-associated antigens

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-60
• Ph+ CML
• HLA A0201, 0301, 1101, B0801
• BCR-ABL b3a2 positive
• no significant comorbidities
• resistance or intolerance of imatinib

You may not qualify if:

• HIV positive
• blast crisis

Sponsors & Collaborators

• University Hospital Carl Gustav Carus: lead

Study Sites (1)

Medizinische Klinik und Poliklinik I

Dresden, 01307, Germany

Location

Related Publications (2)

• Bornhauser M, Thiede C, Babatz J, Schetelig J, Illmer T, Kiani A, Platzbecker U, Herr W, Rieber EP, Ehninger G, Schmitz M. Infusion of bcr/abl peptide-reactive donor T cells to achieve molecular remission of chronic myeloid leukemia after CD34+ selected allogeneic hematopoietic cell transplantation. Leukemia. 2006 Nov;20(11):2055-7. doi: 10.1038/sj.leu.2404383. Epub 2006 Aug 31. No abstract available.

  PMID: 16990776 RESULT

• Bornhauser M, Thiede C, Platzbecker U, Kiani A, Oelschlaegel U, Babatz J, Lehmann D, Holig K, Radke J, Tuve S, Wermke M, Wehner R, Jahnisch H, Bachmann MP, Rieber EP, Schetelig J, Ehninger G, Schmitz M. Prophylactic transfer of BCR-ABL-, PR1-, and WT1-reactive donor T cells after T cell-depleted allogeneic hematopoietic cell transplantation in patients with chronic myeloid leukemia. Blood. 2011 Jun 30;117(26):7174-84. doi: 10.1182/blood-2010-09-308569. Epub 2011 May 3.

  PMID: 21540460 DERIVED

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 Officials

• Martin Bornhäuser, MD

  Medical Clinic, University Hospital Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2007
• First Posted: April 16, 2007
• Study Start: March 1, 2005
• Primary Completion: December 1, 2011
• Last Updated: June 20, 2013

Record last verified: 2013-06

Locations

DE (1)