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Trial record 3 of 4 for:    "T-Cell Adult Acute Lymphocytic Leukemia" | "Zidovudine"

High Risk Adult T-cell Leukemia/Lymphoma (ATLL-HR) and Allogeneic Transplant (ATLL-HR-01)

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ClinicalTrials.gov Identifier: NCT01941680
Recruitment Status : Active, not recruiting
First Posted : September 13, 2013
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

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

Condition or disease
T-cell Lymphoma Leukaemia

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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
Actual Study Start Date : October 31, 2013
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : March 2021


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




Primary Outcome Measures :
  1. Number of patients with relapse [ Time Frame: Up to 3 year ]

Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Populations of French Caribbean Islands and Guyana with ATLL-HR. .
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941680


Locations
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Guadeloupe
CHU Pinteà Pitre/Abymes
Pointe à Pitre, Guadeloupe
Martinique
CHU de Martinique
Fort de France, Martinique
Sponsors and Collaborators
University Hospital Center of Martinique

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT01941680     History of Changes
Other Study ID Numbers: 13/B/04
2013-A00327-38 ( Other Identifier: AFSSAPS )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Zidovudine
Lymphoma
Leukemia
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents