Autologous Cytomegalovirus (CMV) Specific CD8+ T Cells as Treatment for CMV Reactivation

NCT01326273 | Withdrawn Phase 1

• 1 other identifier: JROHH0202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will assess whether the infusion of autologous CMV-specific T-cells at the time of CMV reactivation posttransplant will prevent worsening of CMV virus reactivation posttransplant to a level that warrants therapy with antiviral drugs (objectively assessed by looking at CMV virus copy number).

Conditions

CMV Reactivation; Allogeneic Stem Cell Transplantation; Autologous CMV Specific CD8+ T Cells

Keywords

CMV; cytomegalovirus; autologous; leukemia; hematological malignancies; stem cell transplantation; CMV reactivation; adoptive therapy

Outcome Measures

Primary Outcomes (1)

• Response to adoptive transfer of autologous CMV-specific CD8+ T-cells

  Response to CMV-specific CD8+ T-cells administration will be measured and defined as a CMV DNA PCR\< 50 copies.

  Up to three years

Secondary Outcomes (4)

• The occurrence of subsequent CMV reactivations

  Up to three years

• Rate of complete response

  Up to three years

• Rate of early complete response

  Up to three years

• Rate of subsequent CMV reactivation

  Up to three years

Interventions

Lymphopheresis PROCEDURE

Lymphopheresis

CMV specific lymphocyte infusion PROCEDURE

CMV specific lymphocyte infusion

Peripheral blood for CMV DNA PCR PROCEDURE

Peripheral blood for CMV DNA PCR

Haematology/Blood chemistry PROCEDURE

Haematology/Blood chemistry analysis, Collection of blood for ancillary laboratory tests.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have received an allogeneic stem cell transplant from any donor, as treatment for a haematological malignancy.
• HLAA0201 positive at one allele
• CMV seropositive
• The patient must be willing and capable of donating lymphocytes for CMVspecific CD8+ T cell selection using apheresis techniques
• The patient must be in complete remission with no evidence of circulating blasts or other malignant cells
• Patient must be fit to undergo leukapheresis
• Patients must have signed an informed consent form before undergoing LP prior to alloSCT
• Indications for infusion of autologous CMV specific CD8+ Tcells:
• Therapeutic: CMV disease following allogeneic stem cell transplantation
• Preemptive: CMV reactivation (by CMV DNA PCR)
• autologous CMV specific CD8+ T-cells must be infused into the patient no later than 72 following CMV reactivation.
• Steroids should be withdrawn at least 1 week before the infusion of CMVspecific CD8+ T-cell
• Patients must have signed an informed consent form before the infusion of autologous CMV specific CD8+ T-cells

You may not qualify if:

• Patient CMV seronegative
• No informed consent
• Patient positive at the time of LP for one of the following infectious agents: HIV, HBV, HCV,Syphilis, HTLV 1 and 2
• Patient with circulating leukemic blasts at the time of LP
• Severe GvHD (grade IIII-V) requiring full dose immunosuppressive treatment

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Leukemia; Hematologic Neoplasms

Interventions

Leukapheresis; Blood Chemical Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Katy Rezvani, MD

  Imperial College Healthcare NHS Trust

  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: March 22, 2011
• First Posted: March 30, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2012-03

Locations

GB (1)