R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma

Part of paid clinical trials in New York, New York.

Sponsor: Lymphoma Study Association
Study ID: NCT00137995
Phase: PHASE3
Status: Completed

Conditions

Lymphoma, Large-Cell, Diffuse

Eligibility Criteria

Sex: ALL
Age: 18 Years - 65 Years
Healthy Volunteers: Not accepted

Interventions

Rituximab — DRUG
375 mg/m² D-2/D1
Etoposide — DRUG
100 mg/m² D1-D2-D3
Carboplatine — DRUG
max 800mg D2
Ifosfamide + Mesna — DRUG
5 g/m² from D2 to D13
Cisplatine — DRUG
100 mg/m² from D1 to D13
Cytosine Arabinoside — DRUG
2000 mg/m²/12 h D2 D3
Dexamethasone — DRUG
40 mg From D1 to D4
Autologous Stem Cell Transplantation — PROCEDURE
BCNU — DRUG
300mg/m² on D-6
Etoposide — DRUG
200 mg/m² from D-6 to D-3
Cytarabine — DRUG
100 mg/m² from D-6 to D-3
Melphalan — DRUG
140 mg/m² on D-2

Study Details

The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20. The goal is to detect a difference in mobilization adjusted response rate of 15% between R-ICE and R-DHAP. The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival. The goal is to obtain a 15% increase of event free survival at 2 years.

Key Dates

Start date: Jun 30, 2003
Status verified: Aug 2019
Primary completion: Oct 31, 2008
Completion: Oct 31, 2008

Study Design

Enrollment: 481 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: R-ICE
R-ICE + R-BEAM /ASCT Rituximab, Etoposide, Carboplatine, Ifosfamide + Mesna BCNU, Etoposide, Cytarabine, Melphalan Autologous Stem Cell Transplantation
Experimental: R-DHAP
R-DHAP + R-BEAM /ASCT Rituximab, Cisplatine, Cytosine Arabinoside, Dexamethasone BCNU, Etoposide, Cytarabine, Melphalan Autologous Stem Cell Transplantation

Primary Outcome Measure

MARR (mobilization adjusted response rate) [ Time Frame: 3 months ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Memorial Sloan Kettering Cancer Center	New York	New York	10021	-

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By research site

Memorial Sloan Kettering Cancer Center· New York, NY