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Multicentric Randomized Phase III Study Comparing High Doses of Chemotherapy With Rituximab Followed by Auto-transplant HPC Versus CHOP Plus Rituximab as First Line Therapy in High Risk Patients With DLBCL Non-Hodgkin's Lymphomas

Phase 3
18 Years
65 Years
Open (Enrolling)
Diffuse Large B-Cell Lymphoma

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Trial Information

Multicentric Randomized Phase III Study Comparing High Doses of Chemotherapy With Rituximab Followed by Auto-transplant HPC Versus CHOP Plus Rituximab as First Line Therapy in High Risk Patients With DLBCL Non-Hodgkin's Lymphomas

Diffuse large B cells Non-Hodgkin's lymphomas represents one of the most frequent form of
lymphoma. Its clinical development progresses rapidly and is characterized by a biphasic
survival curve with patients in complete remission (which can be considered cured) and
patients that relapse. This last group of subjects have only 25%-33% chance of long free
disease survival if treated with a second line therapy with high dose chemotherapy plus
autologous transplant of PBPC.

Therefore in order to achieve an improvement of the overall survival in patient with DLBCL,
it is necessary to increase the number of complete remission after first line therapy.

The aim of R-HDS study, multicentre randomized phase III trial, is to evaluate and compare
the efficacy and safety of an intensive conditioning regimen with high intensity
chemo-immunotherapy (R-HDS) plus autologous transplantation versus CHOP conditioning regimen
plus Rituximab in patients with unfavorable prognosis at diagnosis.

Inclusion Criteria:

- Diagnosis of DLBCL CD20+.

- Patients with Ann Arbor classification B-bulk >= II

- Patients of age between 18-65 with age-adjusted IPI 2-3 and ECOG performance status
0-3 or patients of age 61-65 with IPI 3, 4, 5 and ECOG performance status 0-2. The
disease stage criteria must be documented with instrumental examinations and bone
marrow biopsy.

- Hematology parameters one week before starting study as follows: Hb >= 9 g/dl, WBC >=
3 x 10exp9/l, neutrophils >= 1.5 x 10exp9/l, PLT >= 100 x 10exp9/l.

- Patients with pulmonary DLCO >= 50% and cardiac EF >= 40%.

- Voluntary written informed consent must be signed before recruitment, with the
understanding that consent may be withdrawn by the subject at any time without
prejudice to future medical care. Patients must to be informed on the risk of
sterility and they must agree to use contraception for the duration of the study.
Male subject have to the opportunity of freezing seminal fluid.

Exclusion Criteria:

- Diagnosis different from that describe above.

- Patients with concomitant, serious and uncontrolled illnesses such as cardiopathies
(i.e. congestive cardiopathy, ischemic hearth disease, cardiac arrhythmia not
controlled by therapy, IMA in the last six months, hearth disease NYHA class III or
IV), hepatopathy not related to the lymphoma (bilirubin >= 2 mg/dl, ALT >= 2.5 times
the normal value, alkaline phosphatase >=2.5 times the upper limit), kidneys
insufficiency not related to the lymphoma (creatinine >=2 mg/dl).

- Patients affected by opportunistic infections or with positive serology for HIV, HCV,
HbsAg (cases with normal levels of hepatic enzymes and not showing active viral
replication documented with HBV-DNA are not excluded from randomization; patients
with HBV+ can be enrolled after receiving prophylaxis with lamivudina one week before
starting chemotherapy. These patients should be monitored twice a month for HbsAg,

- Patients which have or have had another type of cancer exception made for skin
cancers (melanoma and "in situ" cervical cancer not included).

- Patient with a history of anaphylaxes or more generally patients which have had any
serious allergic reaction after serum infusion.

- Patient with uncontrolled epilepsy, CNS disorders or psychiatric problems which,
according to the investigator, is likely to interfere with participation in this
clinical study (i.e. the signing of the informed consent, therapy compliance).

- Inability to attend follow-up visits.

Type of Study:


Study Design:

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

Outcome Measure:

Event free survival

Outcome Time Frame:

each 2 month during therapy administration and 1,3,6,9,12, 18, 24 months from end of therapy

Safety Issue:


Principal Investigator

Sergio Cortelazzo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Divisione di Ematologia - Ospedale Centrale di Bolzano - 39100 Bolzano Italy


Italy: Ministry of Health

Study ID:

EUDRACT: 2005-00700-14



Start Date:

May 2005

Completion Date:

December 2011

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • R-HDS
  • R-CHOP14
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse