Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy
NCT01679119
ABOUT THIS STUDY
FOR MORE INFORMATION
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Pfizer Clinical Trials Contact Center
1-800-718-1021
- Informed written consent for the trial
- Histologically proven diffuse large B cell lymphoma (DLBCL) according to the current World Health Organisation (WHO) classification including all morphological variants. The B cell nature of the proliferation must be verified by demonstration of CD20 positivity. A concurrent (synchronous) diagnosis of low grade lymphoma (e.g. on bone marrow trephine or presence of both low grade and DLBCL in a lymph node biopsy) or previous diagnosis of low grade lymphoma which hasn't been treated with a systemic therapy is permitted
- Bulky Stage IA (lymph node or lymph node mass ≥ 10cm in maximum diameter), stage IB, stage II, stage III and stage IV disease
- ECOG performance status 0-2
- Measurable disease
- Age 18 ≥ years
- Adequate contraceptive precautions for all patients of childbearing potential
- History of malignant disease diagnosed at any time in the past with completed radical treatment and the risk of relapsing within the next 5 years is <10%. Patients previously treated should be free of sequelae of treatment which would compromise the delivery of study drugs as compared with other eligible patients.
- No previous chemotherapy, radiotherapy or other investigational drug for this indication - previous corticosteroids up to a dose equivalent to prednisolone 1mg/kg/day for up to 14 days are permitted prior to randomisation EITHER
- Unsuitable for anthracycline-containing chemotherapy due to impaired cardiac function defined by an ejection fraction of ≤ 50% OR Left ventricle ejection fraction > 50% but in the presence of significant co-morbidities (diabetes mellitus, hypertension or ischaemic heart disease) precluding anthracycline-containing chemotherapy as determined by treating physician. Co-morbidities must be documented on the randomisation form and CIRS score recorded
- Adequate bone marrow function (Platelets > 100x109/l, WBC > 3.0x109/l, Neutrophils > 1.5x109/l) at time of study entry unless attributed to bone marrow infiltration by DLBCL
- Life expectancy > 3 months
- Symptomatic central nervous system or meningeal involvement by DLBCL
- Previous diagnosis of low grade lymphoma which has been treated with a systemic
therapy
- Non-bulky stage IA disease
- ECOG performance status 3-4
- History of chronic liver disease or suspected alcohol abuse
- Serum bilirubin greater than upper limit of normal unless attributable to Gilberts
syndrome or haemolysis
- Alanine and/or aspartate aminotransferase levels (ALT and/or AST) and alkaline
phosphatase (ALP) greater than 2.5 times the upper limit of normal
- Glomerular filtration rate (GFR) < 30ml/min. GFR calculated by Cockroft-Gault (not
eGFR).
- Serological evidence of active hepatitis B or C infection whether acute or chronic
(defined as positive anti-HCV serology; positive HBsAg). All positive HBcAb results
should also be excluded on safety grounds regardless of HBsAg or HBV DNA status.
Antibodies to Hepatitis B surface antigen (anti-HBs) due to a history of past
vaccination is acceptable
- Known history of HIV seropositive status
- Patients with a history of Venoocclusive Disease (VOD) and Sinusoidal Obstructive
Syndrome (SOS)
- Patients with a screening of QTcF interval >470msec
- Medical or psychiatric conditions compromising the patient's ability to give informed
consent
- Women who are pregnant or lactating
- LVEF > 50% in the absence of significant co-morbidities that preclude anthracycline
use
- Patients with a history of severe allergic/anaphylactic reaction to any humanised
monoclonal antibody
- Patients with serious active infection
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Descriptive Information | ||||
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Brief Title ICMJE | Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy | |||
Official Title ICMJE | A Randomised Phase II Trial of Inotuzumab Ozogamicin Plus Rituximab & CVP (IO-R-CVP) vs Gemcitabine Plus Rituximab & CVP (Gem-R-CVP) for the First Line Treatment of Patients With DLBCL Who Are Not Suitable for Anthracycline Containing Chemotherapy | |||
Brief Summary | The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy. There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP). | |||
Detailed Description | The incidence of DLBCL is increasing and with an expanding elderly population, the incidence will continue to rise. Given that about 40% of cases of DLBCL occur in patients aged over 70 and the number of co-mobilities increases with age, research to investigate the optimal treatment of DLBCL in this group of patients is needed. R-CHOP remains the standard of care for the majority of patients with DLBCL, anthracycline use is precluded in a proportion of these patients by a high risk of developing cardiotoxicity, especially congestive cardiac failure. Currently there is no standard of care for patients who are unfit for anthracycline treatment. It has been routine to omit the doxorubicin from R-CHOP, giving R-CVP instead. However the outcome for patients treated with R-CVP is poor and attempts have been made to replace the doxorubicin with alternative agents. The trial will compare an experimental arm consisting of Inotuzumab Ozogamicin added to the standard immunochemotherapy regimen of rituximab, cyclophosphamide, vincristine and prednisolone (R-CVP) with the control arm of gemcitabine added to the same combination (Gem-R-CVP). | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Diffuse Large B Cell Lymphoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Estimated Enrollment ICMJE | 132 | |||
Original Estimated Enrollment ICMJE | 154 | |||
Estimated Study Completion Date ICMJE | October 2021 | |||
Actual Primary Completion Date | March 2019 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01679119 | |||
Other Study ID Numbers ICMJE | UCL 11/0475 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University College, London | |||
Study Sponsor ICMJE | University College, London | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University College, London | |||
Verification Date | November 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |