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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00562965
Other study ID # 3129K4-3301
Secondary ID B19310062007-000
Status Terminated
Phase Phase 3
First received November 21, 2007
Last updated December 8, 2017
Start date November 2007
Est. completion date April 2011

Study information

Verified date December 2017
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.


Description:

On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.


Recruitment information / eligibility

Status Terminated
Enrollment 29
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have received 1 or 2 prior regimens, at least 1 of which should have contained administration of rituximab (either as a single agent or in combination).

- Age 18 years or older.

- ECOG performance status <= 2.

- ANC >= 1.5 x 10^9/L (1500/mL) and platelets >= 75 x 10^9/L (75,000/mL), serum creatinine <= 1.5 x ULN and urine protein to creatinine ratio of <= 0.5, total bilirubin <= 1.5 x ULN, AST and ALT <= 2.5 x ULN.

- At least 1 measurable disease lesion that is >= 1.5 cm x 1.5 cm by CT or MRI, in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.

Exclusion Criteria:

- Subjects with clinical evidence of transformation to a more aggressive subtype of lymphoma or grade 3b follicular lymphoma.

- Subjects whose disease is rituximab refractory, meaning that they did not have a CR or PR, or that they experienced disease progression within 6 months from the initiation of the rituximab or rituximab containing treatment regimen administered immediately preceding study enrollment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
inotuzumab ozogamicin
IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
rituximab
IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
rituximab
intravenous rituximab at a dose of 375 mg/m2 on day 1
cyclophosphamide
intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
vincristine
intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
prednisone/prednisolone
oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
mitoxantrone
mitoxantrone 10 mg/m2 intravenous on day 2
fludarabine
fludarabine 25 mg/m2 intravenous on days 2 through 4
dexamethasone
oral dexamethasone 20 mg/day on days 1-5

Locations

Country Name City State
Argentina Centro de Transplantes de medula Osea de Rosario, CETRAMOR Rosario Santa FE
Belgium Universitair Ziekenhuis Gent Gent
Belgium Oncologisch Centrum GZA - Location St. Augustinus Wilrijk
Canada Hopital Charles LeMoyne Greenfield Park Quebec
Canada Jewish General Hospital Montreal Quebec
Canada C.H.A. Enfant-Jesus Quebec
Canada CHUS-Hopital Fleurimont Sherbrooke Quebec
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Prince of Wales Hospital Shatin NEW Territories
India B. P. Poddar Hospital and Medical Research Ltd. Kolkata WEST Bengal
India Jehangir Clinical Development Centre Pune Maharashtra
India MMF Joshi Hospital and Ratna Memorial Hospital Pune Maharashtra
Italy Divisione di Ematologia - Fondazione IRCCS Policlinico San Matteo Pavia
Korea, Republic of Yonsei University Health System-Severance Hospital Seoul
Mexico Hospital Universitario de Nuevo Leon Monterrey Nuevo LEON
Poland Instytut Hematologii i Transfuzjologii Warszawa
Portugal Hospitais Da Universidade De Coimbra Coimbra
Russian Federation Moscow Regional Research Clinical Institute named after Vladimirsky Moscow
South Africa Wits Donald Gordon Clinical Trial Site Johannesburg Gauteng
Spain Hospital Santa Creu I Sant Pau Barcelona
Spain Hospital de La Princesa Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Madrid
United States Advanced Oncology Associates Armonk New York
United States The Harry & Jeanette Weinberg Cancer Inst at Franklin Square Baltimore Maryland
United States Avi Einzing, MD Bronx New York
United States Hematology and Oncology Associates Columbus Mississippi
United States Hematology and Oncology Associates Corinth Mississippi
United States Deaconess Clinic Evansville Indiana
United States Hackensack University Medical Center Hackensack New Jersey
United States The Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States Facey Medical Group Mission Hills California
United States Hematology Oncology Associates of Northern New Jersy Morristown New Jersey
United States Advanced Oncology Associates New Rochelle New York
United States Newland Medical Associates Novi Michigan
United States Marc Zimmerman, MD Pomona New York
United States Park Nicollet Frauenshuh Cancer Center Saint Louis Park Minnesota
United States Newland Medical Associates, PC Southfield Michigan
United States Hematology and Oncology Associates at Bridgepoint Tupelo Mississippi
United States Wenatchee Valley Medical Center Wenatchee Washington

Sponsors (2)

Lead Sponsor Collaborator
Pfizer UCB Pharma

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Hong Kong,  India,  Italy,  Korea, Republic of,  Mexico,  Poland,  Portugal,  Russian Federation,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Clinically Significant Change From Baseline in QT Interval Findings Assessments of QT interval was performed only in rituximab + inotuzumab ozogamicinin group. QT interval corrected using Fridericia's formula (QTcF) and Bazett's formula (QTcB) was analyzed as per common terminology criteria for adverse events (CTCAE) version 3.0, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening or disabling AE, Grade 5 = death related to AE. Number of participants with change in CTCAE grading at post-baseline time point compared to the baseline were presented. The post-baseline value was defined as the maximum grade after the first dose date on or before the end of treatment. Baseline up to 42 days post-treatment
Other Number of Participants With Grade 3 or 4 Treatment Emergent Adverse Events (TEAEs) AE=any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. TEAE=between first dose of study drug and up to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Baseline up to 42 days post-treatment
Other Number of Participants With Clinically Significant Change From Baseline in Laboratory Findings Criteria for laboratory test abnormality: Blood Chemistry (alkaline phosphatase [greater than{>}5*upper limit of normal {ULN}, calcium [less than {<}1.75 millimole per liter {mmol/L}, creatinine [>3*ULN], glucose [>13.9 mmol/L], phosphorous [<0.6 mmol/L], potassium [<3 mmol/L], aspartate transaminase [>5.0*ULN], total bilirubin [>3*ULN]), Coagulation (international normalized ratio [>2*ULN]), Hematology (hemoglobin [<80 grams/Liter], lymphocytes [<0.5*10^9/L], absolute neutrophil count [<1*10^9/L], platelet count [<50*10^9/L], WBC [<2.0*10^9/L]). Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
Other Number of Participants With Clinically Significant Change From Baseline in Vital Signs Criteria for determining significant change from baseline in vital signs abnormalities: heart rate value of <40 beats per minute and value >150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, temperature <32 or >40 degree centigrade, and body weight>=10% increase or decrease of body weight in kilogram (kg). Baseline up to 42 days post-treatment, disease follow up (every 12 weeks for a minimum of 1 year and up to 2 years)
Primary Progression-Free Survival (PFS) PFS was defined as the time from randomization to disease progression or death due to any cause, whichever occurred first, censored at the last tumor evaluation date. PFS calculated as (Months) = (first event date minus randomization date plus 1) divided by 30.44. Baseline until disease progression or death or up to 1 year after last dose of study drug
Secondary Percentage of Participants With Objective Response (OR) OR was based on assessment of complete response(CR),unconfirmed CR(Cru),partial response(PR) as per International Response Criteria for Non-Hodgkin's Lymphoma.Confirmed response=response persists on repeat imaging at least 4 weeks after initial response.CR=complete disappearance of all detectable clinical/radiographic evidence of disease,lymph nodes regressed to normal size [at least 1.5 centimeter(cm) or less],spleen regressed,not palpable on physical examination,bone marrow infiltrate cleared on repeat aspiration/biopsy.PR=at least 50 percent (%) decrease in sum of product diameters of 6 greatest dominant nodes,no increase in other nodes,liver/spleen,no new sites of disease. CRu=residual lymph node greater than 1.5 cm in transverse diameter that has regressed more than 75% in product diameter.Individual nodes previously confluent,regressed more than 75% in product diameters.Indeterminate bone marrow (increased number/size of lymph aggregates without cytologic/architectural atypia). Baseline, every 6 to 12 weeks during treatment period, end of treatment (EOT) (42 days after last dose), every 12 weeks during follow-up for up to 1 year after the last dose of study drug
Secondary Overall Survival Probability at Months 6, 12 and 24 Overall survival was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. Participants who withdrew or lost to follow-up from study without having death documented were censored at the date of last contact. Kaplan-Meier estimates of the probability of survival at 6, 12 and 24 months was used to estimate the survival function. Baseline up to Month 6, 12, 24
Secondary Pharmacokinetics of Inotuzumab Ozogamicin in Combination With Rituximab 0, 1, 168 hours on Cycle 1, 2; 0, 1, 2, 168 hours on Cycle 3, 4
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