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NCT01941680 Clinical Trial

High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant

T-cell Lymphoma Clinical Trial

— ATLL-HR-01  

Official title:
Observational Prospective Study, Evaluating the Standard of Care as Recommend by International Consensus With Zidovudine-Pegylated Interferon +/-Polychemotherapy in High Risk Adult-T-cell Lymphoma/Leukaemia (T-cell Lymphoma/Leukaemia) Followed by Allogeneic Transplant Among Eligible Patients Younger Than 65 Years Old

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01941680
Other study ID # 13/B/04
Secondary ID 2013-A00327-38
Status Completed
Phase
First received
Last updated
Start date October 31, 2013
Est. completion date March 2021

Study information
Verified date June 2021
Source University Hospital Center of Martinique
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients are recruited at diagnosis or at relapse of ATLL-HR in French Caribbean islands and Guyana. They all receive Zidovudine and Pegylated Interferon (ZPI). For patients younger than 65 years old, an allogeneic donor is searching out. Patients included at relapse and with lymphoma clinico-biological subtype also receive chemotherapy (CT). Responses are assessed during ZPI+/-CT and eligible patients (depending on age, comorbidities and response criteria) receive allogeneic transplant. Patient follow-up is planned for 3 years old

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2021
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patient >18 years old and = 75 years old, with ATLL-HR who signed informed consent. Exclusion Criteria: - Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Guadeloupe CHU Pinteà Pitre/Abymes Pointe à Pitre
Martinique CHU de Martinique Fort de France

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Center of Martinique

Countries where clinical trial is conducted

Guadeloupe,  Martinique, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with relapse Up to 3 year
Secondary Evidence of presence of gene expression of Tax and HBZ confirmed by Rt-PCR The titrations of genes are performed at month 12, month 24 and month 36 1 year
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