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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

Primary Purpose

High-Grade Lymphomas

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

HDS vs ProMECE/CytaBOM

About this trial

This is an interventional treatment trial for High-Grade Lymphomas

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

GISL Trial Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HDS

ProMECE/CytaBOM

Arm Description

modified high dose sequential therapy

four additional courses of standard ProMECE/CytaBOM

Outcomes

Primary Outcome Measures

remission duration

overall survival

event-free survival

freedom-from progression

Secondary Outcome Measures

feasibility and toxicity

Full Information

NCT ID

NCT00866203

First Posted

March 13, 2007

Last Updated

March 19, 2009

Sponsor

Gruppo Italiano Studio Linfomi

1. Study Identification

Unique Protocol Identification Number

NCT00866203

Brief Title

HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

October 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Gruppo Italiano Studio Linfomi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High-Grade Lymphomas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

441 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HDS

Arm Type

Experimental

Arm Description

modified high dose sequential therapy

Arm Title

ProMECE/CytaBOM

Arm Type

Active Comparator

Arm Description

four additional courses of standard ProMECE/CytaBOM

Intervention Type

Drug

Intervention Name(s)

HDS vs ProMECE/CytaBOM

Primary Outcome Measure Information:

Title

remission duration

Time Frame

end of treatment

Title

overall survival

Time Frame

study end

Title

event-free survival

Time Frame

study end

Title

freedom-from progression

Time Frame

study end

Secondary Outcome Measure Information:

Title

feasibility and toxicity

Time Frame

end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: