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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


Phase 3
18 Years
65 Years
Not Enrolling
Both
High-Grade Lymphomas

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

remission duration

Outcome Time Frame:

end of treatment

Safety Issue:

No

Principal Investigator

Nicola Di Renzo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

GISL

Authority:

Italy: Ethics Committee

Study ID:

LA05

NCT ID:

NCT00866203

Start Date:

October 2000

Completion Date:

April 2008

Related Keywords:

  • High-Grade Lymphomas
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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