Radiolabeled Monoclonal Antibody Plus Rituximab With and Without Filgrastim and Interleukin-11 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study has been terminated.
(Trial completed prematurely.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00012298
First received: March 3, 2001
Last updated: November 4, 2015
Last verified: December 2012
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Interventions: Biological: rituximab
Biological: yttrium Y 90 ibritumomab tiuxetan
Biological: indium In 111 ibritumomab tiuxetan
Biological: oprelvekin
Biological: filgrastim

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment: Trial 1, Dose Level 1

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Treatment: Trial 1, Dose Level 2

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Treatment: Trial 2, Dose Level 3

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Treatment: Trial 2, Dose Level 4

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Treatment: Trial 3, Dose Level 5

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Treatment: Trial 3, Dose Level 6

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Treatment : Phase II (Dose Level 6)

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.


Participant Flow:   Overall Study
    Treatment: Trial 1, Dose Level 1     Treatment: Trial 1, Dose Level 2     Treatment: Trial 2, Dose Level 3     Treatment: Trial 2, Dose Level 4     Treatment: Trial 3, Dose Level 5     Treatment: Trial 3, Dose Level 6     Treatment : Phase II (Dose Level 6)  
STARTED     11     7     9     4     5     6     39  
COMPLETED     11     7     9     4     5     6     39  
NOT COMPLETED     0     0     0     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment: Trial 1, Dose Level 1

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Treatment: Trial 1, Dose Level 2

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Treatment: Trial 2, Dose Level 3

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Treatment: Trial 2, Dose Level 4

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.

Treatment: Trial 3, Dose Level 5

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Treatment: Trial 3, Dose Level 6

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Treatment : Phase II (Dose Level 6)

Patients receive:

Cycle 1:

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8

Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):

250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.

Patients also receive:

480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.

50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.

Total Total of all reporting groups

Baseline Measures
    Treatment: Trial 1, Dose Level 1     Treatment: Trial 1, Dose Level 2     Treatment: Trial 2, Dose Level 3     Treatment: Trial 2, Dose Level 4     Treatment: Trial 3, Dose Level 5     Treatment: Trial 3, Dose Level 6     Treatment : Phase II (Dose Level 6)     Total  
Number of Participants  
[units: participants]
  11     7     9     4     5     6     39     81  
Age  
[units: years]
Median (Full Range)
  60  
  (39 to 70)  
  56  
  (31 to 65)  
  52  
  (37 to 70)  
  51  
  (30 to 67)  
  46  
  (42 to 60)  
  59  
  (28 to 62)  
  58  
  (36 to 76)  
  58  
  (28 to 76)  
Gender  
[units: participants]
               
Female     4     4     2     2     3     1     17     33  
Male     7     3     7     2     2     5     22     48  
Region of Enrollment  
[units: participants]
               
Saudi Arabia     0     0     0     1     0     0     0     1  
Croatia     1     0     0     0     0     0     0     1  
United States     10     7     9     3     5     6     39     79  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)   [ Time Frame: At 8 weeks ]

2.  Primary:   Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)   [ Time Frame: Assessed up to week 24 ]

3.  Primary:   Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)   [ Time Frame: At 3 years ]

4.  Secondary:   Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I)   [ Time Frame: At week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I)   [ Time Frame: At week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)   [ Time Frame: At week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Survival (Phase II)   [ Time Frame: From registration to death due to any cause, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Time to Disease Progression (Phase II)   [ Time Frame: From registration to the earliest date documentation of > disease progression, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Tumor Response Rate (Phase II)   [ Time Frame: Assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas E. Witzig, M.D.
Organization: Mayo Clinic
e-mail: witzig.thomas@mayo.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00012298     History of Changes
Obsolete Identifiers: NCT01646879
Other Study ID Numbers: NCI-2009-00008
NCI-2009-00008 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000068503
MC998C ( Other Identifier: Mayo Clinic )
312 ( Other Identifier: CTEP )
Study First Received: March 3, 2001
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration