Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse

NCT01562990

Last updated date
Study Location
AZ Sint Jan
Bruges, , 8000, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diffuse Large B-Cell Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically documented CD20 and CD22 positive diffuse large B-cell lymphoma, according to WHO classification. CD20 and CD22 immunophenotyping at initial diagnosis is acceptable. If such prior documentation is not available, then the immunophenotyping at relapse must be established by fine-needle aspirate or biopsy or by circulating CD20 and CD22 positive NHL cells from peripheral blood during screening. Upon registration the pathological report confirming the diagnosis, must be available

- In first or second relapse or refractory to first and/or second line treatment. Refractory is defined as having exhibited less than or PR to a prior rituximab containing regimen or having relapsed within 6 months of the last dose of a prior rituximab containing regimen.

- Measurable disease by bidimensional transverse CT scan assessment

- Not eligible for autologous transplantation.

- Previously treated with a chemotherapy regimen containing anthracyclines and rituximab.

- Aged 18 - 80 years.

- ECOG performance status 0 to 2.

- Minimum life expectancy of 3 months.

- Signed written informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Burkitt, mantle cell and T-cell lymphomas.


- Central nervous system or meningeal involvement by the lymphoma.


- Contraindication to any drug contained in the R-GEMOX combination chemotherapy.


- Treatment with any investigational drug within 30 days before the first planned cycle
of chemotherapy and during the study.


- Nitrosurea or mitomycin C administration within 6 weeks prior to study start.


- Major debulking surgery within 3 weeks of treatment.


- Any of the following lab abnormalities (unless related to the lymphoma or bone marrow
infiltration):


Absolute neutrophil count (ANC) < 1.500/µL (1,5.109/L).


Platelet count < 100.000/µL (100.109/L).


Creatinin level > 150 µmol/L (1,7 mg/dL) or 1,5 - 2,0x ULN.


Total bilirubin level > 30 µmol/L (1,8 mg/dL) or 1,5x ULN.


Serum AST/SGOT or ALT/SGPT >2,5x ULN.


- Documented infection with HIV, active hepatitis B or C infection.


- Any serious active disease or co-morbid medical condition that, according to the
investigator's decision, will substantially increase the risk associated with the
subject's participation in the study. Prior history of malignancies other than
lymphoma with the exception of non-melanoma skin tumors (basal cell or squamous cell
carcinoma of the skin) or stage 0 (in situ) cervical carcinoma unless the subject has
been disease-free for 5 or more years..


- LVEF less than 50% (measured by echocardiography or scintigraphy).


- Previous myocardial infarction or pulmonary hypertension within 6 months before the
first dose of investigational product.


- Congestive heart failure NYHA stage III or IV


- Known chronic liver disease (eg. Cirrhosis) or suspected alcohol abuse.


- Pregnant or lactating females


- Men and women who are biologically capable of having children not willing to use an
adequate method of birth control during the study and up to 18 months after the last
dose of investigational product.


- Adult patient unable to provide informed consent because of intellectual impairment,
any serious medical condition, laboratory abnormality or psychiatric illness.

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NCT01562990
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Advanced Information
Descriptive Information
Brief Title  ICMJE Phase Ib/II Study of the Efficacy and Safety of the R-CMC544/R-GEMOX Combination in Diffuse Lage B-cell Lymphoma at First or Second Relapse
Official Title  ICMJE A Multi-center, Phase IB/II, Open Label, Single Arm Study of Inotuzumab Ozogamicin Plus Rituximab (R-CMC544) Alternating With Gemcitabine-oxaliplatin Plus Rituximab(R-GEMOX)in Patients Aged From 18 to 80 Years With CD20 and CD22 Positive Diffuse Large B-cell Lymphoma (DLBCL) in Relapse After/Refractory to 1ST or 2ND Line Treatment, Who Are no Candidates for Autologous Transplant.
Brief Summary The purpose of this study is to determine the recommended dose of CMC544 administered in combination with rituximab (R-CMC544), and in alternance with rituximab, gemcitabine and oxaliplatin (R-GEMOX) in the first phase of the study. After that, efficacy and safety of this combination will be evaluated preliminarily in patients with DLBCL in relapse or refractory, who are no candidates for autologous transplant.
Detailed Description

This study is a multicenter, phase Ib/II, open-label, single arm trial evaluating the efficacy and safety of R-CMC544 alternated with R-GEMOX in patients with CD20 and CD22 positive DLBCL in relapse after/refractory to 1st or 2nd line treatment, who are no candidates for autologous transplant.

The study consists of 2 phases. In part 1 (potential dose de-escalation phase) subjects will be enrolled at a fixed dose of CMC544. In case of occurrence of dose limiting toxicity (DLT), cohorts of 3 to 6 subjects will evaluate a de-escalating dose of CMC544 in combination with set doses of rituximab, gemcitabine and oxaliplatin in order to obtain the MTD or recommended dose of CMC544 in this regimen. In part 2 (dose expansion phase) further safety and preliminary efficacy data of the proposed combination will be analyzed.

All patients will receive two 56 day induction cycles of alternating R-CMC544 (given on day 1) and R-GEMOX (given on day 29 and 43). Patients who obtain CR or PR, will then go on a consolidation of another two 56 day cycles of alternating R-CMC544 (given on day 1) and R-GEMOX (given on day 29 and 43).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Large B-Cell Lymphoma
Intervention  ICMJE Drug: Rituximab, CMC544, Gemcitabine and Oxaliplatine

2 cycles of induction of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.

2 cycles of consolidation of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.

Study Arms  ICMJE Experimental: R-CMC544 and R-GEMOX
Treatment with R-CMC544 and R-GEMOX
Intervention: Drug: Rituximab, CMC544, Gemcitabine and Oxaliplatine
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2012)
40
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented CD20 and CD22 positive diffuse large B-cell lymphoma, according to WHO classification. CD20 and CD22 immunophenotyping at initial diagnosis is acceptable. If such prior documentation is not available, then the immunophenotyping at relapse must be established by fine-needle aspirate or biopsy or by circulating CD20 and CD22 positive NHL cells from peripheral blood during screening. Upon registration the pathological report confirming the diagnosis, must be available
  • In first or second relapse or refractory to first and/or second line treatment. Refractory is defined as having exhibited less than or PR to a prior rituximab containing regimen or having relapsed within 6 months of the last dose of a prior rituximab containing regimen.
  • Measurable disease by bidimensional transverse CT scan assessment
  • Not eligible for autologous transplantation.
  • Previously treated with a chemotherapy regimen containing anthracyclines and rituximab.
  • Aged 18 - 80 years.
  • ECOG performance status 0 to 2.
  • Minimum life expectancy of 3 months.
  • Signed written informed consent.

Exclusion Criteria:

  • Burkitt, mantle cell and T-cell lymphomas.
  • Central nervous system or meningeal involvement by the lymphoma.
  • Contraindication to any drug contained in the R-GEMOX combination chemotherapy.
  • Treatment with any investigational drug within 30 days before the first planned cycle of chemotherapy and during the study.
  • Nitrosurea or mitomycin C administration within 6 weeks prior to study start.
  • Major debulking surgery within 3 weeks of treatment.
  • Any of the following lab abnormalities (unless related to the lymphoma or bone marrow infiltration):

Absolute neutrophil count (ANC) < 1.500/µL (1,5.109/L).

Platelet count < 100.000/µL (100.109/L).

Creatinin level > 150 µmol/L (1,7 mg/dL) or 1,5 - 2,0x ULN.

Total bilirubin level > 30 µmol/L (1,8 mg/dL) or 1,5x ULN.

Serum AST/SGOT or ALT/SGPT >2,5x ULN.

  • Documented infection with HIV, active hepatitis B or C infection.
  • Any serious active disease or co-morbid medical condition that, according to the investigator's decision, will substantially increase the risk associated with the subject's participation in the study. Prior history of malignancies other than lymphoma with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma of the skin) or stage 0 (in situ) cervical carcinoma unless the subject has been disease-free for 5 or more years..
  • LVEF less than 50% (measured by echocardiography or scintigraphy).
  • Previous myocardial infarction or pulmonary hypertension within 6 months before the first dose of investigational product.
  • Congestive heart failure NYHA stage III or IV
  • Known chronic liver disease (eg. Cirrhosis) or suspected alcohol abuse.
  • Pregnant or lactating females
  • Men and women who are biologically capable of having children not willing to use an adequate method of birth control during the study and up to 18 months after the last dose of investigational product.
  • Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (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 Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562990
Other Study ID Numbers  ICMJE CMC-R-GEMOX
2011-003849-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Lymphoma Academic Research Organisation
Study Sponsor  ICMJE The Lymphoma Academic Research Organisation
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Fritz OFFNER, MDLymphoma Study Association
Study Chair:Corinne HAIOUN, PhDLymphoma Study Association
PRS Account The Lymphoma Academic Research Organisation
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP