Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

NCT00562965

Last updated date
Study Location
Facey Medical Group
Mission Hills, California, 91345, 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, Follicular
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

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


- 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.

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Lymphoma, FollicularStudy Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL) NCT00562965
  1. Mission Hills, California
  2. Evansville, Indiana
  3. Baltimore, Maryland
  4. Novi, Michigan
  5. Southfield, Michigan
  6. Saint Louis Park, Minnesota
  7. Columbus, Mississippi
  8. Corinth, Mississippi
  9. Tupelo, Mississippi
  10. Hackensack, New Jersey
  11. Hackensack, New Jersey
  12. Morristown, New Jersey
  13. Armonk, New York
  14. Bronx, New York
  15. New Rochelle, New York
  16. Pomona, New York
  17. Wenatchee, Washington
  18. Rosario, Santa FE
  19. Gent,
  20. Wilrijk,
  21. Greenfield Park, Quebec
  22. Montreal, Quebec
  23. Sherbrooke, Quebec
  24. Quebec,
  25. Shatin, NEW Territories
  26. Hong Kong,
  27. Pune, Maharashtra
  28. Pune, Maharashtra
  29. Kolkata, WEST Bengal
  30. Pavia,
  31. Seoul,
  32. Monterrey, Nuevo LEON
  33. Warszawa,
  34. Coimbra,
  35. Moscow,
  36. Johannesburg, Gauteng
  37. Majadahonda, Madrid
  38. Barcelona,
  39. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
Official Title  ICMJE An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgkin's Lymphoma
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Lymphoma, Follicular
Intervention  ICMJE
  • Drug: inotuzumab ozogamicin
    IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
  • Drug: rituximab
    IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
  • Drug: rituximab
    intravenous rituximab at a dose of 375 mg/m2 on day 1
  • Drug: cyclophosphamide
    intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
  • Drug: vincristine
    intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
  • Drug: prednisone/prednisolone
    oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
  • Drug: mitoxantrone
    mitoxantrone 10 mg/m2 intravenous on day 2
  • Drug: fludarabine
    fludarabine 25 mg/m2 intravenous on days 2 through 4
  • Drug: dexamethasone
    oral dexamethasone 20 mg/day on days 1-5
Study Arms  ICMJE
  • Experimental: A
    Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days.
    Interventions:
    • Drug: inotuzumab ozogamicin
    • Drug: rituximab
  • Active Comparator: B
    Subjects will receive the investigator's choice from the following rituximab-containing regimens: R-CVP or R-FND. The investigator's choice of therapy will be administered every 21 days. Dosing for R-CVP will be intravenous rituximab at a dose of 375 mg/m2 on day 1, intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1, intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1, and oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5. Dosing for R-FND will be as follows: rituximab 375 mg/m2 intravenous on day 1, mitoxantrone 10 mg/m2 intravenous on day 2, fludarabine 25 mg/m2 intravenous on days 2 through 4 and oral dexamethasone 20 mg/day on days 1-5.
    Interventions:
    • Drug: rituximab
    • Drug: cyclophosphamide
    • Drug: vincristine
    • Drug: prednisone/prednisolone
    • Drug: mitoxantrone
    • Drug: fludarabine
    • Drug: dexamethasone
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 14, 2011)
29
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2007)
978
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Argentina,   Belgium,   Canada,   Hong Kong,   India,   Italy,   Korea, Republic of,   Mexico,   Poland,   Portugal,   Russian Federation,   South Africa,   Spain,   United States
Removed Location Countries Australia,   Brazil,   Chile,   Colombia,   Costa Rica,   Croatia,   Czech Republic,   Former Serbia and Montenegro,   France,   Germany,   Guatemala,   Hungary,   Panama,   Peru,   Puerto Rico,   Serbia,   Singapore,   Slovakia,   Taiwan,   Thailand
 
Administrative Information
NCT Number  ICMJE NCT00562965
Other Study ID Numbers  ICMJE 3129K4-3301
B1931006 ( Other Identifier: Alias Study Number )
2007-000219-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 December 2017

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