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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Gruppo Italiano Studio Linfomi

Status and phase

Completed
Phase 3

Conditions

High-Grade Lymphomas

Treatments

Drug: HDS vs ProMECE/CytaBOM

Study type

Interventional

Funder types

Other

Identifiers

NCT00866203
LA05

Details and patient eligibility

About

The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program.

Enrollment

441 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

441 participants in 2 patient groups

HDS
Experimental group
Description:
modified high dose sequential therapy
Treatment:
Drug: HDS vs ProMECE/CytaBOM
ProMECE/CytaBOM
Active Comparator group
Description:
four additional courses of standard ProMECE/CytaBOM
Treatment:
Drug: HDS vs ProMECE/CytaBOM

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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