Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 1320 for:    Hematologic neoplasm

Infusion of Depleted T Cells Following Unrelated Donor Stem Cell Transplant (ICAT) (ICAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01827579
Recruitment Status : Active, not recruiting
First Posted : April 9, 2013
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
University College, London

Brief Summary:
The purpose of this study is to evaluate whether the administration of allodepleted donor T cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system.

Condition or disease Intervention/treatment Phase
Haematological Malignancies Biological: CD25/71 allodepleted donor T-cells Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: CD25/71 allodepleted donor T-cells
CD25/71 allodepleted donor T-cells will be administered at a dose of 10^5 /kg at day 30 post-SCT, 3 x 10^5 /kg at day 60 and 10^6 /kg at day 90 post transplant
Biological: CD25/71 allodepleted donor T-cells
CD25/71 allodepleted donor T-cells will be administered at a dose of 10^5 /kg at day 30 post-SCT, 3 x 10^5 /kg at day 60 and 10^6 /kg at day 90 post transplant

No Intervention: Control (normal HSCT)
Patients randomised to the control arm with undergo stem cell transplantation according to site local practice.



Primary Outcome Measures :
  1. Circulating CD3+ve T cell count at 4 months post-SCT [ Time Frame: 4 months post transplant ]

Secondary Outcome Measures :
  1. Incidence of grade II-IV acute and chronic GVHD [ Time Frame: 1 year post transplant ]
  2. Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping [ Time Frame: 1 year post transplant ]
  3. In vitro anti-viral responses of circulating PBMC [ Time Frame: 1 year post transplant ]
  4. Transplant related mortality at 1 year post-SCT [ Time Frame: 1 year post transplant ]
  5. Disease-free survival at 1 year post-SCT [ Time Frame: 1 year post transplant ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥16 years
  • Underlying haematological malignancy
  • Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
  • Written Informed consent

Exclusion Criteria:

  • Life expectancy < 6 weeks
  • Female patients who are pregnant and lactating
  • Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827579


Locations
Layout table for location information
United Kingdom
University College London Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Sponsors and Collaborators
University College, London
Medical Research Council
Investigators
Layout table for investigator information
Study Chair: Persis Amrolia Great Ormond Street Hospital for Children NHS Foundation Trust

Layout table for additonal information
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01827579     History of Changes
Other Study ID Numbers: UCL/11/0519
2013-000872-14 ( EudraCT Number )
MR/K007491/1 ( Other Grant/Funding Number: Medical Research Council )
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Keywords provided by University College, London:
Transplant
CD25/71 allodepleted donor T cells
Infection
Acute Myeloid Leukaemia
Acute Lymphoblastic Leukaemia
Adult
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases