Clinical Trials /

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

NCT00637832

Description:

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.

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: CDR0000588042
  • SECONDARY ID: USCTU-SCHRIFT-06-DOG05-44
  • SECONDARY ID: USCTU-SCHRIFT
  • SECONDARY ID: USCTU-RHM-CAN0542
  • SECONDARY ID: EUDRACT 2007-000222-51
  • SECONDARY ID: EU-20819
  • NCT ID: NCT00637832

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
rituximab
cyclophosphamide
doxorubicin hydrochloride
prednisolone
vincristine sulfate

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate, including combined complete response and partial response
Time Frame:
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Time to disease progression
Time Frame:
Safety Issue:
Description:
Measure:Time to next treatment
Time Frame:
Safety Issue:
Description:
Measure:Response duration in patients with responding disease
Time Frame:
Safety Issue:
Description:
Measure:Safety
Time Frame:
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Unknown status
Lead Sponsor:University Hospital Southampton NHS Foundation Trust

Trial 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

Last Updated

October 7, 2009