NCT00012298|TerminatedPhase 1Results

Study Stopped

Trial completed prematurely.

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

Phase I/II Study of Two Sequential Doses of IDEC-Y2B8 in Patients With Relapsed Low-Grade and Follicular Non-Hodgkin's Lymphoma

National Cancer Institute (NCI)ClinicalTrials.gov

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4 other identifiers

NCI-2009-00008CDR0000068503MC998C312

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedApr 2001

CompletionApr 2010

Brief Summary

Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Apr 2001

Longer than P75 for phase_1

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 years study duration

First Submitted

Initial submission to the registry

March 3, 2001

Completed

29 days until next milestone

Study Start

First participant enrolled

April 1, 2001

Completed

1.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed

5.7 years until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed

Last Updated

August 9, 2018

Status Verified

July 1, 2018

Enrollment Period

9 years

First QC Date

March 3, 2001

Results QC Date

November 4, 2015

Last Update Submit

July 9, 2018

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

Outcome Measures

Primary Outcomes (3)

Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)
This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly. \> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event. \> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here.
At 8 weeks
Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)
Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.
Assessed up to week 24
Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)
Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.
At 3 years

Secondary Outcomes (6)

Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I)
At week 12
Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I)
At week 12
Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)
At week 12
Survival (Phase II)
From registration to death due to any cause, assessed up to 5 years
Time to Disease Progression (Phase II)
From registration to the earliest date documentation of>disease progression, assessed up to 5 years
+1 more secondary outcomes

Study Arms (1)

Treatment (radiolabeled monoclonal antibody therapy)

EXPERIMENTAL

Patients receive rituximab IV on days 1 and 8, indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1, and yttrium Y 90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) and interleukin-11 SC until blood counts recover.

Biological: rituximabBiological: yttrium Y 90 ibritumomab tiuxetanBiological: indium In 111 ibritumomab tiuxetanBiological: oprelvekinBiological: filgrastim