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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate, including combined complete response and partial response

Safety Issue:

No

Principal Investigator

Tim Illidge

Investigator Role:

Principal Investigator

Investigator Affiliation:

Christie Hospital NHS Foundation Trust

Authority:

Unspecified

Study ID:

CDR0000588042

NCT ID:

NCT00637832

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

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