NCT01751243

Brief Summary

Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre, prospective, of cohort of patients who will receive different doses of allo-depleted lymphocytes . This project joins in this pioneering worldwide initiative with its own technology based on the use of proteasome inhibitors in vitro, which advantages are, over other methods described, the continuing viability of regulatory T cells and the use of a product to generate allo-depletion that, contrary to those reported by other research groups, it does not pose problems from the point of view of its use or toxicity as we employ a drug widely used clinically by intravenous administration.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

September 1, 2017

Enrollment Period

5.9 years

First QC Date

December 13, 2012

Last Update Submit

July 4, 2018

Conditions

Transplant-Related Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events and serious adverse events after allo-depleted lymphocyte infusion in vitro.

    6 months

Secondary Outcomes (1)

  • Incidence of acute and chronic GVHD

    6 months

Study Arms (6)

Group 0

PLACEBO COMPARATOR

Haploidentical transplantation of hematopoietic progenitors

Other: Haploidentical transplantation of hematopoietic progenitors

Group 1

EXPERIMENTAL

Allo-depleted lymphocyte infusion dose: 1x105 CD3/Kg

Other: Allo-depleted lymphocyte infusion

Group 2

EXPERIMENTAL

Allo-depleted lymphocyte infusion dose: 3x105 CD3/Kg

Other: Allo-depleted lymphocyte infusion

Group 3

EXPERIMENTAL

Allo-depleted lymphocyte infusion dose: 5x105 CD3/Kg

Other: Allo-depleted lymphocyte infusion

Group 4

EXPERIMENTAL

Allo-depleted lymphocyte infusion dose: 1x106 CD3/Kg

Other: Allo-depleted lymphocyte infusion

Group 5

EXPERIMENTAL

Allo-depleted lymphocyte infusion dose: 3x106 CD3/Kg

Other: Allo-depleted lymphocyte infusion

Interventions

Allo-depleted lymphocyte infusionOTHER

Doses: 1x105 CD3/Kg; 3x105 CD3/Kg; 5x105 CD3/Kg; 1x106 CD3/Kg;31x106 CD3/Kg;

Group 1Group 2Group 3Group 4Group 5
Haploidentical transplantation of hematopoietic progenitorsOTHER

Haploidentical transplantation of hematopoietic progenitors without subsequent infusion of allo-depleted lymphocytes.

Group 0

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adult patients aged between 16 and 50 years.

You may not qualify if:

  • General condition\> Eastern Cooperative Oncology Group (ECOG) scale 2.
  • Left Ventricular ejection fraction (LVEF) \<39%.
  • Diffusion capacity of lung for carbon monoxide (DLCO) and forced vital capacity (FVC) \<39% of the theoretical values.
  • Impaired liver function (total bilirubin higher than 2 mg / dL and / or transaminases higher than 3 times the normal maximum.
  • Creatinine clearance \<50 mL / minute.
  • Presence of symptomatic heart, liver cirrhosis or chronic active hepatitis.
  • Active tuberculosis.
  • Serious diseases which prevent chemotherapy treatments.
  • Associated neoplasias (active neoplasias which, according to the opinion of the investigator and the sponsor, could jeopardize patient safety).
  • Presence of associated psychiatric pathology.
  • HIV infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital Reina Sofia

Córdoba, 14004, Spain

Location

University Hospital Carlos Haya

Málaga, 29010, Spain

Location

University Hospital de Salamanca

Salamanca, 37007, Spain

Location

University Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Related Links

Study Officials

  • Jose-Antonio Perez-Simón, MD, PhD

    University Hospital Virgen del Rocío

    PRINCIPAL INVESTIGATOR

  • Antonio Torres, MD, PhD

    University Hospital Reina Sofía

    PRINCIPAL INVESTIGATOR

  • Lucía Lopez-Corral, MD, PhD

    University Hospital de Salamanca

    PRINCIPAL INVESTIGATOR

  • Mª Ángeles Cuesta, MD, PhD

    University Hospital Carlos Haya

    PRINCIPAL INVESTIGATOR
0

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

December 13, 2012

First Posted

December 17, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 6, 2018

Record last verified: 2017-09

Locations

ES(4)