CompletedPhase 2/3

Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

Italy121 participantsStarted 2005-03

Plain-language summary

The purpose of this study is to compare Reduced Intensity Conditioning protocols containing either Thymoglobuline or Alemtuzumab in patients undergoing allogeneic transplant from voluntary unrelated donors.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Group 1: 55-65 yo patients suffering from Acute Myeloblastic and Lymphoblastic Leukemia, Myelo-displasia, Chronic Myeloid Leukemia and Idiopathic Myelofibrosis (according to IBMDR operative manual) * Group 2: patients \<= 65 yo suffering from lympho-proliferative diseases according the REAL classification: * High-doses chemotherapy relapsed CLL (B and T) * Follicular lymphoma relapsed after 2 standard chemotherapy regimens or after high-doses chemotherapy * Mantellar lymphoma relapsed after 1 standard chemotherapy regimen or after high-doses chemotherapy * Lympho-plasmacytoid and B marginal zone lymphoma in relapse after 2 standard chemotherapy regimens or after high-doses chemotherapy * Advanced (stage ≥ III A) or relapsed T lymphomas * Large B-cells lymphomas in 2nd or further complete remission after relapse from high dose chemotherapy and autotransplant or after 2 standard chemotherapy regimens * Fungal mycosis in advanced stage (≥ III A) or in chemosensitive relapse after 2 lines of chemotherapy and Sezary syndrome in chemosensitive relapse after 1 line of chemotherapy * Hodgkin disease relapse after autotransplant with chemosensitive disease or in relapse after 1 year from chemotherapy and not eligible for autotransplant since an insufficient mobilization of autologous hemopoietic stem cells. Exclusion Criteria: * Performance status \< 70% (Karnofsky) * Left ventricular cardiac ejection fraction \< 40% or receiving treatment for heart failure * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival

Timeframe: 3 years

Event Free Survival and Disease Free Survival

Timeframe: 3 years

Safety:

Timeframe: 3 years

Major infective complications (CMV and EBV related PTLD)

Timeframe: 3 years

Acute and chronic GvHD

Timeframe: 3 years

Trial details

NCT IDNCT00354120

SponsorGruppo Italiano Trapianto di Midollo Osseo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Acute Myeloblastic Leukemia trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.