NCT05390671

Brief Summary

The prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

April 27, 2022

Last Update Submit

May 26, 2022

Conditions

CART Therapy

Outcome Measures

Primary Outcomes (3)

  • Progression free survival

    Patients who relapse or progress at 6 month after CART infussion.

    6 month

  • Progression free survival

    Patients who relapse or progress at 12 month after CART infussion.

    12 month

  • Progression free survival

    Patients who relapse or progress at 24 month after CART infussion.

    24 month

Secondary Outcomes (3)

  • Overall survival

    6 month,12 month and 24 month

  • High relevance toxicity rates

    During the firs month

  • Progression free survival

    6 month,12 month and 24 month

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients \>18, with hematologic malignancies (lymphoma, leukemia, myeloma) in which the use of CAR-T therapy is approved, undergoing CAR-T therapy in Spain.

You may qualify if:

  • Adult patients \>18 y/o
  • Patients receiving CAR-T cell therapy in Spain, since 2018.

You may not qualify if:

  • Patients receiving CART therapy as part of a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angel Cedillo

Madrid, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 25, 2022

Study Start

November 1, 2020

Primary Completion

January 1, 2021

Study Completion

June 1, 2021

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

ES(1)