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

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

Study Overview

• Status: Completed
• Conditions: T-cell Lymphoma; Leukaemia

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Guadeloupe
  • Pointe à Pitre, Guadeloupe
    • CHU Pinteà Pitre/Abymes
• Martinique
  • Fort de France, Martinique
    • CHU de Martinique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Populations of French Caribbean Islands and Guyana with ATLL-HR. .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with relapse	Up to 3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital Center of Martinique

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2013
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Leukemia; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: 13/B/04; 2013-A00327-38 (Other Identifier: AFSSAPS)