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Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisolone
vincristine sulfate
yttrium Y 90 ibritumomab tiuxetan
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed grade 1, 2, or 3 follicular non-Hodgkin lymphoma

    • Stage II, III, or IV disease (according to the Ann Arbor staging system)
  • CD20-positive disease
  • Initial disease bulk ≤ 10 cm

  • In first or second relapse after prior treatment with a rituximab-containing chemotherapy regimen (R-chemo) or chemotherapy alone

    • Relapse must have occurred ≥ 6 months after completion of R-chemo

      • Relapse that occurred < 6 months after completion of chemotherapy alone allowed

  • Has at least one of the following symptoms requiring initiation of treatment:

    • Nodal mass > 5 cm in its greater diameter
    • B symptoms
    • Elevated serum lactate dehydrogenase (LDH) or β2-microglobulin
    • Involvement of ≥ 3 nodal sites (each with a diameter > 3 cm)
    • Symptomatic splenic enlargement
    • Compressive syndrome
  • No primary refractory disease
  • No large pleural or peritoneal effusions
  • No CNS disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 1,000/mm³
  • Serum creatinine < 1.5 times upper limit of normal (ULN)
  • Total bilirubin < 1.5 times ULN
  • AST < 5 times ULN
  • No active obstructive hydronephrosis
  • No evidence of active infection requiring IV antibiotics
  • No advanced heart disease or other serious illness that would preclude study evaluation
  • No known HIV infection
  • No human anti-mouse antibody (HAMA) reactivity
  • No known hypersensitivity to murine antibodies or proteins
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No other prior malignancy, except for adequately treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior investigational drugs and recovered
  • No prior radioimmunotherapy

Sites / Locations

  • Christie Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Dorset Cancer Centre
  • Southampton General Hospital
  • Saint Bartholomew's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single group

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate, including combined complete response and partial response

Secondary Outcome Measures

Time to disease progression
Time to next treatment
Response duration in patients with responding disease
Safety

Full Information

First Posted
March 14, 2008
Last Updated
December 16, 2021
Sponsor
University of Southampton
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1. Study Identification

Unique Protocol Identification Number
NCT00637832
Brief Title
Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma
Official Title
Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
no information
Study Start Date
April 1, 2008 (Actual)
Primary Completion Date
January 6, 2015 (Actual)
Study Completion Date
January 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed follicular non-Hodgkin lymphoma.
Detailed Description
OBJECTIVES: Primary To evaluate the response rates in patients with relapsed follicular non-Hodgkin lymphoma treated with short-duration rituximab and combination chemotherapy (R-chemo) followed by rituximab and yttrium Y 90 ibritumomab tiuxetan. Secondary To evaluate the duration of response in patients treated with this regimen. To evaluate the quality of response in order to determine the conversion rate from partial response to complete response in patients treated with this regimen. To evaluate the toxicity of yttrium Y 90 ibritumomab tiuxetan when administered after 3 courses of R-chemo. OUTLINE: This is a multicenter study. Chemoimmunotherapy (R-CHOP or R-CVP): Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Alternatively, patients who have already been exposed to prior tolerance doses of anthracyclines receive R-CVP comprising rituximab IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 3 weeks for up to 3 courses. Patients with objective evidence of response on CT scan or those with < 25% bone marrow involvement and no signs of bone marrow hypocellularity (< 15%) on bone marrow biopsy proceed to radioimmunotherapy. Radioimmunotherapy: Four to 6 weeks after completion of R-CHOP or R-CVP, patients receive rituximab IV followed no more than 4 hours later by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes. After completion of study therapy, patients are followed periodically for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
yttrium Y 90 ibritumomab tiuxetan
Primary Outcome Measure Information:
Title
Overall response rate, including combined complete response and partial response
Secondary Outcome Measure Information:
Title
Time to disease progression
Title
Time to next treatment
Title
Response duration in patients with responding disease
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed grade 1, 2, or 3 follicular non-Hodgkin lymphoma Stage II, III, or IV disease (according to the Ann Arbor staging system) CD20-positive disease Initial disease bulk ≤ 10 cm In first or second relapse after prior treatment with a rituximab-containing chemotherapy regimen (R-chemo) or chemotherapy alone Relapse must have occurred ≥ 6 months after completion of R-chemo Relapse that occurred < 6 months after completion of chemotherapy alone allowed Has at least one of the following symptoms requiring initiation of treatment: Nodal mass > 5 cm in its greater diameter B symptoms Elevated serum lactate dehydrogenase (LDH) or β2-microglobulin Involvement of ≥ 3 nodal sites (each with a diameter > 3 cm) Symptomatic splenic enlargement Compressive syndrome No primary refractory disease No large pleural or peritoneal effusions No CNS disease PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 6 months Absolute granulocyte count ≥ 1,500/mm³ Platelet count ≥ 1,000/mm³ Serum creatinine < 1.5 times upper limit of normal (ULN) Total bilirubin < 1.5 times ULN AST < 5 times ULN No active obstructive hydronephrosis No evidence of active infection requiring IV antibiotics No advanced heart disease or other serious illness that would preclude study evaluation No known HIV infection No human anti-mouse antibody (HAMA) reactivity No known hypersensitivity to murine antibodies or proteins Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of study treatment No other prior malignancy, except for adequately treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 weeks since prior investigational drugs and recovered No prior radioimmunotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Illidge
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Dorset Cancer Centre
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26849853
Citation
Illidge TM, McKenzie HS, Mayes S, Bates A, Davies AJ, Pettengell R, Stanton L, Cozens K, Hampson G, Dive C, Zivanovic M, Tipping J, Gallop-Evans E, Radford JA, Johnson PW. Short duration immunochemotherapy followed by radioimmunotherapy consolidation is effective and well tolerated in relapsed follicular lymphoma: 5-year results from a UK National Cancer Research Institute Lymphoma Group study. Br J Haematol. 2016 Apr;173(2):274-82. doi: 10.1111/bjh.13954. Epub 2016 Feb 5.
Results Reference
derived

Learn more about this trial

Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma

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