Clinical trial NCT00867087: Study Evaluating Inotuzumab Ozogamicin (CMC-544) Plus Rituximab In Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Official title: An Open-label, Single-arm, Phase 2 Study Of Inotuzumab Ozogamicin Plus Rituximab In Subjects With Relapsed/Refractory Cd22-positive Diffuse Large B-cell Lymphoma, Eligible For Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Keywords: Diffuse large b-cell lymphoma
inotuzumab ozogamicin
autologous stem cell transplant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: UCB Pharma
First posted: 2009-03-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate inotuzumab ozogamicin in combination with rituximab prior to an autologous stem cell transplant (aSCT) in patients with relapsed/refractory diffuse large B-cell Non-Hodgkin's lymphoma.


Eligibility criteria: Inclusion Criteria:

* CD20/CD22-positive diffuse large B-cell NHL that has relapsed after 1 or 2 prior therapies; one prior therapy must include anthracyclines and one must include rituximab in combination with chemotherapy
* Relapsed/disease progression within 12 months after start of prior therapy and/or secondary International Prognostic Index (sIPI) score greater than 1
* Eligible for autologous stem cell transplant (aSCT)

Exclusion Criteria:

* Prior allogeneic hematopoietic stem cell transplant
* Within 6 months prior to test article: autologous transplant, treatment with anti-CD22 antibodies, radio-immunotherapy
* Veno-occlusive disease or sinusoidal obstruction syndrome, chronic liver disease, systemic vasculitides, current or chronic hepatitis B or C infection

Primary outcomes:
measure: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy
timeFrame: Up to 2 years (9 weeks of 3 21-day cycles and every 3 to 6 months during the long-term follow-up period)
Secondary outcomes:
measure: Kaplan-Meier Estimate of Progression Free Survival (PFS) 6 Months After Inotuzumab Ozogamicin Plus Rituximab Therapy
timeFrame: 6 months after the first dose of inotuzumab ozogamicin
measure: Kaplan-Meier Estimate of PFS 2 Years After Inotuzumab Ozogamicin Plus Rituximab Therapy
timeFrame: 2 years after the first dose of inotuzumab ozogamicin
measure: Percentage of Participants With a Response of CR or PR and Who Had Successful Granulocyte Colony Stimulating Factor (G-CSF) Mobilization of Peripheral Blood Stem Cells (PBSCs) Overall and After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy
timeFrame: From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks) and up to approximately 2 to 3 weeks after 6 cycles (up to 21 weeks).
measure: Percentage of Participants With Successful G-CSF Mobilization of PBSC
timeFrame: From the first dose to approximately 2 to 3 weeks after up to 6 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 21 weeks).
measure: Percentage of Participants Who Underwent Autologous Stem Cell Transplant (aSCT)
timeFrame: A minimum of 4 weeks and a maximum of 8 weeks after the last cycle of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 26 weeks).
measure: Event-Free Survival (EFS) After aSCT
timeFrame: From the completion of aSCT through 2 year long-term follow-up period, including but not limited to planned assessments scheduled every 3 to 6 months.
measure: Percentage of Participants With a CR After 3 Cycles of Inotuzumab Ozogamicin Plus Rituximab Therapy
timeFrame: From the first dose to approximately 2 to 3 weeks after 3 cycles of inotuzumab ozogamicin plus rituximab (induction) therapy (up to 12 weeks).
measure: Overall Survival (OS)
timeFrame: From randomization until the date of death, or the date of last contact if no death occurred (up to 2 years).
measure: Percentage of Participants With Any Grade 3/4 Laboratory Abnormality During Therapy
timeFrame: Within 3 days prior each dose of test article, on Day -2, 1, 8, and 15 of Cycles 1 to 3, 2 to 3 weeks after Cycle 3, at the end-of-treatment visit, and every 3 to 6 months during long-term follow-up (up to 2 years).
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) During Inotuzumab Ozogamicin Plus Rituximab Treatment
timeFrame: Treatment emergent AEs were collected from time of first dose to end of trial visit (participants not undergoing consolidation treatment) or until consolidation therapy. SAEs were collected from informed consent until end of trial visit (up to 6 months).
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center, Foster G. McGraw Hospital and Satellites
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Hackensack
country: United States
facility: John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical CenteR
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center (JTCC) at Hackensack University Medical Center (HUMC)
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center, Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern University Hospital - St. Paul
state: Texas
city: Dallas
country: United States
facility: Zale Lipshy University Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas, M. D. Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: University of Texas, MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Madison
country: United States
facility: Pharmaceutical Research Center
state: Wisconsin
city: Lille
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier Cedex 5
country: France
facility: CHU Saint-Eloi
city: Paris
country: France
facility: Hopital Saint Louis
city: Pessac
country: France
facility: Hopital Haut-Leveque
city: Pierre-Benite cedex 114
country: France
facility: CH Lyon Sud
city: Pierre-benite Cedex
country: France
facility: CH Lyon Sud
city: Strasbourg
country: France
facility: Departement d'Hematologie et d'Oncologie-
city: Berlin
country: Germany
facility: Charite Campus Virchow-Kilinikum-
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul/korea
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: