High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant
ATLL-HR-01
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
2 other identifiers
observational
20
2 countries
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2013
CompletedFirst Posted
Study publicly available on registry
September 13, 2013
CompletedStudy Start
First participant enrolled
October 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJune 3, 2021
June 1, 2021
4.3 years
September 3, 2013
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with relapse
Up to 3 year
Secondary Outcomes (1)
Evidence of presence of gene expression of Tax and HBZ confirmed by Rt-PCR
1 year
Study Arms (3)
ZPI
Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week
ZPI+CHOP-21
Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week CHOP-21 Day1 = day 21 (3 cycles) Day 1 Cyclophosphamide : 750 mg/m2, Doxorubicine : 50 mg/m2, Vincristine : 1,4mg/m2, Prednisone : 100mg/day PO. day 2-Day 5 Prednisone 1mg/kg/day PO.
ZPI +DHAP-21
Zidovudine 1000mg/day : Retrovir® 250mg/day) PegINF (Pegasys®) 180μg x1 injection/week DHAP Day 1= day 21 (3 cycles) Day 1 : Cisplatina 100 mg/m2 Day 2 and day 3 : Aracytine 2000mg/m2/day Day 1-day 4 : Dexamethasone 40mg
Eligibility Criteria
Populations of French Caribbean Islands and Guyana with ATLL-HR. .
You may qualify if:
- Patient \>18 years old and ≤ 75 years old, with ATLL-HR who signed informed consent.
You may not qualify if:
- Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Pinteà Pitre/Abymes
Pointe-à-Pitre, Guadeloupe
CHU de Martinique
Fort-de-France, Martinique
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2013
First Posted
September 13, 2013
Study Start
October 31, 2013
Primary Completion
February 1, 2018
Study Completion
March 1, 2021
Last Updated
June 3, 2021
Record last verified: 2021-06