Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Fludarabine

Fludarabine phosphate

Interferons

Antiviral Agents

CHVP + interferon

fludarabine

CHOP + TBI and autotransplant

Bertrand Coiffier, MD

Catherine Sebban, MD

2 parallel studies.

* For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
* For elderly patients (\>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Lymphoma Study Association

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antirheumatic Agents

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

ACVBP

rituximab

Autologous stem cell transplant

Corinne Haioun

Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.

This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .

The duration of the treatment period is approximately 25 weeks and patients are followed until Death.

From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).

The final analysis was performed in June 2005.

Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

One 6mg subcutaneous dose of generic pegfilgrastim in day+1 after autotransplant

One 6mg subcutaneous dose of brand name pegfilgrastim in day+1 after autotransplant

Single 6mg dose of generic pegfilgrastim or brand name pegfilgrastim, at day +1 after autotransplant.

Pegfilgrastim

Cesar H Gutierrez Aguirre

This is a phase 2 clinical trial comparing time to neutrophil recovery after autotrasplant using generic pegfilgrastim vs brand-name pegfilgrastim.

Thirty consecutive adults with lymphoma or myeloma receiving autologous peripheral blood stem cell transplant will be included in this phase 2 clinical trial. Patients will be allocated 1:1 in two groups: one subcutaneous 6 mg dose of generic pegfilgrastim (control group) or one 6mg dose of brand-name pegfilgrastim (intervention group) both at day +1 after the autotransplant. Daily complete blood counts were collected and time to neutrophil (\>0.5x10\^3/microL) and platelet recovery (\>20x10\^3/microL) will be obtained. The investigators will describe the proportion of adverse events and median time to neutrophil and platelet recoveries. Median or mean time to neutrophil recovery and time to platelet recovery will be calculated and compared with Mann-Whitney-Wilcoxon test or student T.

Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant

Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilgrastim for Neutrophil Recovery After Autologous Stem Cell Transplant

Time from autologous transplant to neutrophil count \>0.5x10\^3/microL

Time from autologous transplant to platelet count \>20x10\^3/microL

Hospital Universitario Dr. Jose E. Gonzalez

Clinical Professor

Rituximab + ACVBP regimen plus Pegfilgrastim

Corinne Haioun, MD

Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).

This is a phase II, multicentric, open-label, non-randomized study, evaluating the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients aged 18 to 60 years with previously untreated CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI), and eligible for transplant.

It is anticipated that 60 subjects will be enrolled over 2 years (from 2004 to 2006), in a group sequential manner one planned interim analysis.

The duration of the treatment period is approximately 26 weeks and patients are followed until Death.

The total Duration of the study is expected to be 2.5 years.

Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma

Study of R-ACVBP Regimen Supported by Pegfilgrastim in Previously Untreated Patients Aged From 18 to 60 Years With High-Risk Diffuse Large B-Cell Lymphoma (Age-adjusted Ipi >or= 2)

Amgen

Etoposide

Cytarabine

Cyclophosphamide

Vincristine

Melphalan

Lenograstim

Etoposide phosphate

Carmustine

2-4 courses every 3 weeks with rituximab 375 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 2 and cyclophosphamide 400 mg/m\^2 on days 2-6. Courses were started if granulocytes \>1.5 · 10\^9/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m\^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m\^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day subcutaneously) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM \[carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan\] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m\^2 on days +14 and +21 after autotransplant.

Immunochemotherapy, in vivo purging and autrotransplant

Mario Lazzarino, M.D.

The purpose of this study is to determine the rate and duration of complete remission and molecular response in patients with relapsed/refractory follicular lymphoma, using a combined treatment with rituximab plus chemotherapy followed by in vivo purged peripheral blood stem cells (PBSC) mobilization and autotransplant.

Autologous stem cell transplantation has been shown effective in the long-term control of follicular lymphoma. Lymphoma, however, can progress after high-dose treatments. Lymphoma cells have been proved to contaminate bone marrow and peripheral blood stem cells (PBSC) collections and may contribute to relapse after autotransplant. The presence in peripheral blood and marrow of PCR-detectable cells bearing the bcl-2 rearrangement appeared to be a surrogate marker of disease and the achievement of a bcl-2 negative status is associated with a lower risk of recurrence. Several methods have been attempted to abolish graft contamination: in vitro treatment with cytotoxic agents, in vitro treatment with anti-B-cell monoclonal antibodies and complement, immunomagnetic beads, positive selection of CD34+ cells. All these techniques usually produce loss of cells, are time-consuming and expensive, and neoplastic depletion is often partial with residual polymerase chain reaction (PCR)-positive cells in the graft.

In the last years the chimeric anti-CD20 monoclonal antibody Rituximab has been shown to be an effective therapeutic option for low-grade lymphoma. Owing to the different mechanism of action, the synergism with cytotoxic agents, and the non-overlapping toxicity, Rituximab is an ideal drug for combination with chemotherapy. On this basis, Rituximab has been used during mobilisation procedures as a tool to obtain in vivo purging and collection of lymphoma-free progenitor cells. In addition, several studies have demonstrated that the efficiency of peripheral blood stem cells (PBSC) harvested is not adversely affected by Rituximab and that engraftment and all parameters of hematopoietic recovery are not compromised. The incorporation of Rituximab into sequential high-dose therapy programs produced high rates of clinical and molecular remission in patients with indolent lymphoma, indicating that the antibody has an additive effect on chemotherapy.

Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma

Phase II of Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Patients With Relapsed or Refractory Follicular Lymphoma

PFS is calculated according to the Kaplan-Meier estimator. The observation time of each subject is defined as the time from entry into the study until lymphoma progression or death as a result of any cause whichever occurs first.

The 5-year PFS is the estimated cumulative probability of surviving at least 5 years without progression.

IRCCS Policlinico S. Matteo

2-4 courses every 3 weeks with rituximab 375 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 2 and cyclophosphamide 400 mg/m\^2 on days 2-6. Courses were started if granulocytes \>1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m\^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m\^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM \[carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan\] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m\^2 on days +14 and +21 after autotransplant.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Study for Patients With Follicular Lymphoma Needing Treatment	NCT00140569	Follicular Lymp...	CHVP + interfer... fludarabine CHOP + TBI and ...	18 Years -	Lymphoma Study Association
Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma	NCT00169169	CD20-Positive L...	ACVBP ACE rituximab Autologous stem...	18 Years - 59 Years	Lymphoma Study Association
Efficacy of Generic Pegfilgrastim vs Brand Name Pegfilrastim for Neutrophil Recovery After Autotransplant	NCT05338047	Myeloma Multipl... Lymphoma	Pegfilgrastim	18 Years - 90 Years	Hospital Universitario Dr. Jose E. Gonzalez
Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma	NCT00169143	Untreated CD20-...	Rituximab + ACV... Autologous stem...	18 Years - 61 Years	Lymphoma Study Association
Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma	NCT00366275	Follicular Lymp...	Immunochemother...	18 Years - 60 Years	IRCCS Policlinico S. Matteo
Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma	NCT00366275	Follicular Lymp...	Immunochemother...	18 Years - 60 Years	IRCCS Policlinico S. Matteo
Randomized Study for Patients With Follicular Lymphoma Needing Treatment	NCT00140569	Follicular Lymp...	CHVP + interfer... fludarabine CHOP + TBI and ...	18 Years -	Lymphoma Study Association

Spots Global Cancer Trial Database for autotransplant