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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01941680

Acronym

ATLL-HR-01

Enrollment

Registered

2013-09-13

Start date

2013-10-31

Completion date

2021-03-31

Last updated

2021-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia, T-cell Lymphoma

Brief 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

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of patients with relapse	Up to 3 year

Secondary

Measure	Time frame	Description
Evidence of presence of gene expression of Tax and HBZ confirmed by Rt-PCR	1 year	The titrations of genes are performed at month 12, month 24 and month 36

Countries

Guadeloupe, Martinique

Outcome results