Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma

NCT01055496

Last updated date
Study Location
Davis Cancer Pavillion and Shands Medical Plaza
Gainesville, Florida, 32608, United States
Contact
1-800-718-1021

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

- Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy.

- Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts: subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy or newly diagnosed subjects who are not candidates for anthracycline-based therapy.

- At least 1 measurable disease lesion that is > 1 cm in the longest transverse diameter, with a product of the diameters > 2.25 cm2 by CT or magnetic resonance imaging (MRI).

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


- Candidate for potentially curative therapy such as stem cell transplantation.


- Prior allogeneic hematopoietic stem cell transplantation (HSCT).


- Prior autologous transplantation, radioimmunotherapy, or other anti CD22 immunotherapy
<= 6 months before the first dose of investigational product.


- More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer
regimens.

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Lymphoma, B-CellStudy Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
NCT01055496
  1. Gainesville, Florida
  2. Gainesville, Florida
  3. Gainesville, Florida
  4. Philadelphia, Pennsylvania
  5. Houston, Texas
  6. Federal Way, Washington
  7. Gig Harbor, Washington
  8. Lakewood, Washington
  9. Puyallup, Washington
  10. Tacoma, Washington
  11. Gent,
  12. Leuven,
  13. Edmonton, Alberta
  14. Halifax, Nova Scotia
  15. Toronto, Ontario
  16. Paris Cedex 10,
  17. Paris,
  18. Pierre Benite,
  19. Hong Kong,
  20. Nagoya, Aichi
  21. Chuo-ku, Tokyo
  22. Koto-Ku, Tokyo
  23. Seoul,
  24. Singapore,
  25. Eastleigh, Hants
  26. Southampton, Hants
  27. Southampton, Hants
  28. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
Official Title  ICMJE AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA
Brief Summary This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, B-Cell
Intervention  ICMJE
  • Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone

    Day 1:

    Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg)

    Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4)

    Days 1-5:

    Prednisone at 40 mg/m2

    Each cycle is 3 weeks, with a maximum of 6 cycles total.

    Other Name: CMC-544
  • Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone

    Day 1:

    Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5)

    Day 2:

    Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5)

    Days 1-4:

    Dexamethasone at 40 mg

    Each cycle is 3 weeks, with a maximum of 6 cycles total.

    Other Name: CMC-544
Study Arms  ICMJE
  • Experimental: Arm 1 (R-CVP)
    Subjects in arm 1 will be enrolled in dose escalation cohorts that will initially evaluate an escalating dose of cyclophosphamide in combination with set doses of inotuzumab ozogamicin, vincristine, prednisone, and rituximab.
    Intervention: Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone
  • Experimental: Arm 2 (R-GDP)
    Subjects in arm 2 will be enrolled in dose escalation cohorts that will initially evaluate escalating doses of gemcitabine and/or cisplatinum in combination with set doses of inotuzumab ozogamicin, dexamethasone, and rituximab.
    Intervention: Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone
Publications *

*   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: June 13, 2019)
103
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2010)
100
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy.
  • Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts: subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy or newly diagnosed subjects who are not candidates for anthracycline-based therapy.
  • At least 1 measurable disease lesion that is > 1 cm in the longest transverse diameter, with a product of the diameters > 2.25 cm2 by CT or magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Candidate for potentially curative therapy such as stem cell transplantation.
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT).
  • Prior autologous transplantation, radioimmunotherapy, or other anti CD22 immunotherapy <= 6 months before the first dose of investigational product.
  • More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer regimens.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 Belgium,   Canada,   France,   Hong Kong,   Japan,   Korea, Republic of,   Singapore,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01055496
Other Study ID Numbers  ICMJE 3129K2-1105
B1931003 ( Other Identifier: Alias Study Number )
2009-015497-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE UCB Pharma
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019

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