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Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma (DLCL04)

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ClinicalTrials.gov Identifier: NCT00499018
Recruitment Status : Unknown
Verified February 2011 by Fondazione Italiana Linfomi - ETS.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2007
Last Update Posted : February 15, 2011
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by:
Fondazione Italiana Linfomi - ETS

Study Description
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Brief Summary:

The purpose of this study is to define an improvement in patients randomized in four different arms:

Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells.


Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma IPI≥2 Drug: Rituximab Drug: Ciclofosfamide Drug: Doxorubicina Drug: Vincristina Drug: Prednisone Drug: Pegfilgrastim Drug: Mitoxantrone Drug: ARA-C Drug: Lenograstim Drug: BCNU Drug: VP-16 Procedure: ASCT Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Multicentric Phase III Study for the Treatment of Young Patients With High Risk (IPI 2-3) Diffuse Large B-Cell Lymphoma. Dose Dense Chemotherapy + Rituximab +/- Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cells.
Study Start Date : January 2006
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
R-MegaCHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
 Drug: Rituximab
375 mg/m2 day 1

Drug: Ciclofosfamide
1200 mg/m2 day 1

Drug: Doxorubicina
70 mg/m2 day 1

Drug: Vincristina
1,4 mg/m2 (max 2 mg) day 1

Drug: Prednisone
100 mg day g 1-5

Drug: Pegfilgrastim
6 mg day +1

Drug: Mitoxantrone
8 mg/m2/days 1-3

Drug: ARA-C
2000 mg/m2/12h day 1 - 3

Drug: Lenograstim
5 μg/Kg/days +2

Drug: BCNU
300 mg/m2 day -7

Drug: ARA-C
200 mg/m2/12 days -6,-5,-4,-3

Drug: VP-16
100 mg/m2/12h days -6,-5,-4,-3

Procedure: ASCT
PBSC Reinfusion
Experimental: 1 BIS
R-CHOP14 x 4 Restaging + R-MAD + MAD + BEAM + ASCT
 Drug: Rituximab
375 mg/m2 day 1

Drug: Vincristina
1,4 mg/m2 (max 2 mg) day 1

Drug: Prednisone
100 mg day g 1-5

Drug: Pegfilgrastim
6 mg day +1

Drug: Lenograstim
5 μg/Kg/days +2

Drug: BCNU
300 mg/m2 day -7

Drug: ARA-C
200 mg/m2/12 days -6,-5,-4,-3

Drug: VP-16
100 mg/m2/12h days -6,-5,-4,-3

Procedure: ASCT
PBSC Reinfusion

Drug: Ciclofosfamide
750 mg/m2 day 1

Drug: Doxorubicina
50 mg/m2 day 1

Drug: Vincristina
1,4 mg/m2 (max 2 mg) day 1
Experimental: 2
R-MegaCHOP14 x 4 Restaging + R-MegaCHOP x 2
 Drug: Rituximab
375 mg/m2 day 1

Drug: Ciclofosfamide
1200 mg/m2 day 1

Drug: Doxorubicina
70 mg/m2 day 1

Drug: Vincristina
1,4 mg/m2 (max 2 mg) day 1

Drug: Prednisone
100 mg day g 1-5

Drug: Pegfilgrastim
6 mg day +1

Drug: Mitoxantrone
8 mg/m2/days 1-3

Drug: ARA-C
2000 mg/m2/12h day 1 - 3
Experimental: 2 BIS
R-CHOP14 x 4 Restaging + R-CHOP14 x 4
 Drug: Rituximab
375 mg/m2 day 1

Drug: Vincristina
1,4 mg/m2 (max 2 mg) day 1

Drug: Prednisone
100 mg day g 1-5

Drug: Ciclofosfamide
750 mg/m2 day 1

Drug: Doxorubicina
50 mg/m2 day 1

Drug: Vincristina
1,4 mg/m2 (max 2 mg) day 1


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the activity of arms "R-MegaCHOP14/R-CHOP14 + R-MAD+BEAM and ASCT" and "R-MegaCHOP14/R-CHOP14" in terms of 2-years Failure Free Survival (FFS). [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To evaluate the activity of arms "R-MegaCHOP14/R-CHOP14 + R-MAD+BEAM and ASCT" and "R-MegaCHOP14/R-CHOP14" in terms of 3-years Overall Survival (OS). [ Time Frame: 3 years ]
  2. To evaluate the efficacy of two different dose-dense + Rituximab chemotherapy regimens in term of 2-years Failure Free Survival (FFS). [ Time Frame: 2 years ]
  3. To evaluate the activity of the first four courses of two different dose dense + Rituximab chemotherapy regimens (standard dose R-CHOP14 or intensified dose R-MegaCHOP14) in terms of Overall Response Rate (ORR) and Complete Remission (RC). [ Time Frame: 2 years ]
  4. To evaluate the efficacy of the four different induction arms in terms of 2-years FFS (exploratory analysis). [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-60;
  2. Histological confirmed diagnosis of Diffuse Large B-Cell Lymphoma CD20+ (newly diagnosis or shifted from low grade NHL and not previously treated) or of Follicular Lymphoma grade III according to REAL/WHO Classification.
  3. Advanced stage II, stage III and stage IV with at least two aa-IPI risk factors.
  4. Age-adjusted IPI 2-3.
  5. ECOG performance status 0-2.
  6. LVEF>45%, measured with echocardiography.
  7. Normal hepatic, renal and pulmonary functions.
  8. HIV, HCV and HBV negativity.
  9. HCV+ admitted only in histologically confirmed absence of replication marks.
  10. Positive serology for HBV (occult carriers: AntiHBcAg+, HbsAg-, AntiHBsAg+/-) admitted only upon negativity of weakly positive HBV-DNA test.
  11. Life expectancy > 3 months.
  12. Negative pregnancy test.
  13. Written Informed Consent.

Exclusion Criteria:

  1. Histological diagnosis of:

    • Lymphoblastic NHL
    • Burkitt's Lymphoma
    • CD 20 negative B-cell Lymphoma
    • grade I-IIIa Follicular Lymphoma
    • Mantle Cell Lymphoma
    • Primary mediastinal NHL with exclusively intrathoracic localization.
  2. Age > 60
  3. Stage I disease
  4. Age-adjusted IPI 0-1
  5. ECOG-PS>3, if not related to Lymphoma
  6. Renal impairment (creatinine>1,2 mg/dl or creatinine clearance < 60ml/min)
  7. Hepatic impairment (AST/ALT or bilirubin > 2,5 times normal limit, unless due to Lymphoma)
  8. HIV positive patients and/or with HBV or HCV active infection(documented by HBV-DNA and HCV-RNA positive tests)
  9. 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
  10. LFEV<45%
  11. Severe diabetes mellitus difficult to control with adequate insulin therapy
  12. Severe chronic obstructive pulmonary disease with hypoxemia
  13. Active bacterial, viral of fungal infection requiring systemic therapy
  14. Concurrent thrombohemolytic disease
  15. HIV positivity
  16. HBV positivity
  17. Positive serology for HBV (occult carriers: AntiHBc+, HbsAg-, AntiHbs+/-) with positive HBV-DNA test
  18. HCV positivity in presence of replication marks (HCV+, CRP+, AST 1,5-2 times normal ranges)
  19. CNS localization of disease
  20. Prior (during last 3 years) or concurrent malignancy except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix or early stage prostate cancer not requiring systemic therapy, or early breast cancer treated with surgery alone. Any other co.existing medical condition that would preclude study therapy administration
  21. Pregnancy or breast-feeding women
  22. Inability of the patient to give her/his informed consent
  23. Known hypersensitivity or anaphylactic reaction to murine antibodies or proteins
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499018


Locations
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Sponsors and Collaborators
Fondazione Italiana Linfomi - ETS
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators
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Principal Investigator: Umberto Vitolo, MD S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Umberto Vitolo, A.O. San Giovanni Battista - Molinette Torino
ClinicalTrials.gov Identifier: NCT00499018    
Other Study ID Numbers: IIL-DLCL04
EudraCT number 2007-000275-42
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011
Keywords provided by Fondazione Italiana Linfomi - ETS:
Large B-Cell Lymphoma
Rituximab
Autologous Stem Cell Transplantation
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Prednisone
Rituximab
Mitoxantrone
Cyclophosphamide
 Vincristine
Doxorubicin
Liposomal doxorubicin
Lenograstim
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antimetabolites, Antineoplastic