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

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

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Key information

Conditions

T-cell Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukaemia Leukemia Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Pinteà Pitre/Abymes, Pointe-à-Pitre, Guadeloupe

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of patients with relapse

Time frame: Up to 3 year

Secondary outcomes

Evidence of presence of gene expression of Tax and HBZ confirmed by Rt-PCR

Time frame: 1 year

The titrations of genes are performed at month 12, month 24 and month 36

Sponsors and collaborators

Lead sponsor

University Hospital Center of Martinique

Other

Registry information

Official study 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

Acronym: ATLL-HR-01

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2021
First posted: Sep 13, 2013
Registry last updated: Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed