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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00866203 |
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Date of registration:
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13/03/2007 |
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Primary sponsor: |
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Public title:
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HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy
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Scientific title:
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A Prospective, Randomized, Multicenter Trial Comparing a Modified HDS Therapy Supported by PBPC Transplant With Additional 4 Courses of Front-Line Therapy in Adult Aggressive NHL With PR After Short Course of Up-Front Chemotherapy |
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Date of first enrolment:
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October 2000 |
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Target sample size:
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441 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00866203 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Italy
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Contacts
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Name:
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Mario Petrini, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GISL |
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Name:
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Massimo Federico, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GISL |
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Name:
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Maura Brugiatelli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GISL |
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Name:
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Nicola Di Renzo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GISL |
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Name:
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Paolo G Gobbi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GISL |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newly diagnosed, untreated patients with histologically documented aggressive
lymphoma;
- Age between 18 and 65 years;
- Clinical stage at diagnosis: I A bulky - IV B;
- Reduction of tumoral masses, after four courses of induction therapy, between 50
and 75%;
- Serum negativity for HIV, HbsAg and HCV;
- ECOG performance status 0 through 4;
- Adequate bone marrow function;
- Adequate renal and hepatic functions;
- Left ventricular ejection fraction (LVEF) > 50%;
- No previous malignant disease;
- No previous chemo-radiotherapy;
- No cerebral or CNS involvement, assessed by clinical history, physical examination
and CSF examination through lumbar puncture;
- Written informed consent given at time of randomization.
Exclusion Criteria:
- Clinical stage I no bulky, or CS IIA-B with less than three sites of disease
involved;
- Patients with CR, unconfirmed complete remission (uCR), very good PR (>75%) and
clinical response less than 50%, as defined by Cheson et al., following four courses
of induction therapy;
- Tumor involvement of CNS (except patients with peridural masses without liquor
involvement , who can be enrolled in this study);
- Indolent lymphoma transformed in more aggressive histologic type, even if never
previously treated;
- Aggressive non-Hodgkin's lymphoma in pre-transplanted patient;
- Clinically significant secondary cardiovascular disease e.g. uncontrolled
hypertension, (resting diastolic blood pressure > 115 mmHg), uncontrolled multifocal
cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA
class III-IV;
- Left ventricular ejection fraction (LVEF) < 50%;
- Evidence of any severe active acute or chronic infection;
- Concurrent malignancy of history of other malignancy, except basal cell carcinoma of
the skin (BCC) and in situ cervical carcinoma (CIN);
- myelodisplastic syndrome;
- HbsAg, HIV-positive, or HCV-RNA-positive patients;
- Patient with psychiatric, or any disorder that compromises ability to give truly
informed consent for participation in this study;
- Pregnant woman; potential child-bearing women can be enrolled if adequate
contraceptive precautions are used before entering this trial and for the duration
of the trial;
- Concerns for patient's compliance with the protocol procedures.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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High-Grade Lymphomas
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Intervention(s)
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Drug: HDS vs ProMECE/CytaBOM
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Primary Outcome(s)
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event-free survival
[Time Frame: study end]
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freedom-from progression
[Time Frame: study end]
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overall survival
[Time Frame: study end]
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remission duration
[Time Frame: end of treatment]
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Secondary Outcome(s)
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feasibility and toxicity
[Time Frame: end of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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