NCT00366275

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

October 18, 2010

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

5 years

First QC Date

August 17, 2006

Results QC Date

February 18, 2009

Last Update Submit

October 26, 2012

Conditions

Follicular Lymphoma

Keywords

follicular lymphomarituximabimmunochemotherapyperipheral blood stem cells (PBSC) mobilizationin vivo purgingautotransplantbcl-2 rearrangementmolecular response

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival

    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.

    every 3 months for the first year after autotransplant and every 6 months after the first year of follow up

Study Arms (1)

In vivo purging autotransplant

EXPERIMENTAL
Procedure: Immunochemotherapy, in vivo purging and autrotransplant

Interventions

Immunochemotherapy, in vivo purging and autrotransplantPROCEDURE

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.

In vivo purging autotransplant

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with relapsed or refractory follicular lymphoma after chemotherapy
  • Patients with relapsed or refractory follicular lymphoma after rituximab as single agent or with chemotherapy
  • Patients with transformed follicular lymphoma
  • CD20-positivity
  • Age between 18 and 60 years
  • Advanced Ann Arbor stage
  • Normal cardiac, renal and hepatic functions
  • Negativity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Total amount of anthracycline previously received \< 300 mg/m\^2

You may not qualify if:

  • Creatinine \> 2 mg/dl
  • Alanine transaminase (ALT) and alkaline phosphatase \> 2N
  • Cardiac or pulmonary disease
  • Severe organic or psychiatric disease
  • Positivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Pregnancy, breastfeeding
  • Cancer diagnosis in the 5 years before lymphoma diagnosis, except of non-melanoma skin cancer and Cervical Intraepithelial Neoplasia (CIN)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Hematology, IRCCS Policlinico S. Matteo, University of Pavia

Pavia, 27100, Italy

Location

Related Publications (4)

  • Lazzarino M, Arcaini L, Bernasconi P, Alessandrino EP, Gargantini L, Cairoli R, Orlandi E, Astori C, Brusamolino E, Pagnucco G, Colombo AA, Calatroni S, Iacona I, Regazzi MB, Morra E. A sequence of immuno-chemotherapy with Rituximab, mobilization of in vivo purged stem cells, high-dose chemotherapy and autotransplant is an effective and non-toxic treatment for advanced follicular and mantle cell lymphoma. Br J Haematol. 2002 Jan;116(1):229-35. doi: 10.1046/j.1365-2141.2002.03256.x.

    PMID: 11841421BACKGROUND

  • Arcaini L, Orlandi E, Alessandrino EP, Iacona I, Brusamolino E, Bonfichi M, Bernasconi P, Calatroni S, Tenore A, Montanari F, Troletti D, Pascutto C, Regazzi M, Lazzarino M. A model of in vivo purging with Rituximab and high-dose AraC in follicular and mantle cell lymphoma. Bone Marrow Transplant. 2004 Jul;34(2):175-9. doi: 10.1038/sj.bmt.1704551.

    PMID: 15170171BACKGROUND

  • Arcaini L, Montanari F, Alessandrino EP, Tucci A, Brusamolino E, Gargantini L, Cairoli R, Bernasconi P, Passamonti F, Bonfichi M, Zoli V, Bottelli C, Calatroni S, Troletti D, Merli M, Pascutto C, Majolino I, Rossi G, Morra E, Lazzarino M. Immunochemotherapy with in vivo purging and autotransplant induces long clinical and molecular remission in advanced relapsed and refractory follicular lymphoma. Ann Oncol. 2008 Jul;19(7):1331-1335. doi: 10.1093/annonc/mdn044. Epub 2008 Mar 15.

    PMID: 18344536RESULT

  • Arcaini L, Morello L, Tucci A, Rusconi C, Ladetto M, Rattotti S, Bonfichi M, Bottelli C, Gabutti C, Bernasconi P, Varettoni M, Gotti M, Troletti D, Guerrera ML, Fiaccadori V, Sciarra R, Ferretti VV, Alessandrino EP, Rossi G, Morra E. Autologous stem cell transplantation with in vivo purged progenitor cells shows long-term efficacy in relapsed/refractory follicular lymphoma. Am J Hematol. 2015 Mar;90(3):230-4. doi: 10.1002/ajh.23919.

    PMID: 25502635DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Luca Arcaini MD
Organization
Division of Hematology, Fondazione IRCCS Policlinico San Matteo, University of Pavia
luca.arcaini@unipv.it
+390382501308

Study Officials

  • Mario Lazzarino, M.D.

    Division of Hematology, IRCCS Policlinico S. Matteo, University of Pavia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

January 1, 2002

Primary Completion

January 1, 2007

Study Completion

September 1, 2007

Last Updated

October 31, 2012

Results First Posted

October 18, 2010

Record last verified: 2012-10

Locations

IT(1)