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

December 16, 2021 updated by: University of Southampton

Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
    • England
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Dorset Cancer Centre
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single group
Drug: cyclophosphamide
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Biological: rituximab
Drug: prednisolone
Radiation: yttrium Y 90 ibritumomab tiuxetan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate, including combined complete response and partial response

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2008

Primary Completion (Actual)

January 6, 2015

Study Completion (Actual)

January 6, 2015

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 14, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000588042
  • USCTU-SCHRIFT-06-DOG05-44 (Other Identifier: USCTU)
  • USCTU-RHM-CAN0542 (Other Identifier: USCTU-RHM)
  • 2007-000222-51 (EudraCT Number)
  • EU-20819 (Other Identifier: EU)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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