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Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study


OBJECTIVES:

- Compare the response rate and quality of remission in patients with relapsed follicular
non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) with or without rituximab.

- Compare the event-free survival and overall survival of patients treated with these
regimens.

- Determine the effect of rituximab as maintenance therapy on progression-free survival
of these patients.

OUTLINE: This is a randomized, multicenter study.

- Induction: Patients are randomized to one of two treatment arms. Patients are
stratified according to participating center, prior treatment with purine analogues,
age, number of prior induction treatments and best response obtained (complete vs
partial remission vs no change/progressive disease), time since diagnosis (less than 2
years vs more than 2 years), and bulky disease (less than 10 cm vs greater than 10 cm).

- Arm I (closed as of 12/20/04): Patients receive induction chemotherapy comprising
cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 and oral
prednisone on days 1-5 (CHOP chemotherapy). Treatment repeats every 3 weeks for 6
courses in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive CHOP chemotherapy as in arm I. Rituximab IV is
administered 1 hour after prednisone and before the IV drugs.

- Maintenance: Patients who achieve partial or complete remission are then randomized to
one of two treatment arms. Patients are stratified according to rituximab
administration during induction (yes vs no), quality of the response (complete vs
partial remission vs no change/progressive disease), and participating center.

- Arm I: Patients receive no further therapy.

- Arm II: Beginning 8 weeks after the last CHOP course, patients receive rituximab
IV once every 3 months for up to 2 years in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 4 months thereafter.

PROJECTED ACCRUAL: A total of 752 patients will be accrued for this study within 6 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically proven stage III or IV follicular non-Hodgkin's
lymphoma (NHL)

- Relapsed after or no response (no change/progressive disease) to no more than 2
adequate non-anthracycline-containing systemic chemotherapy regimens

- At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR

- At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide,
vincristine, and prednisone) or purine analogues

- Complete or partial remission or no change for at least 4 weeks after completion of
prior therapy OR progression during one of a maximum of 2 prior therapy regimens

- CD20 positive

- At least 1 bidimensionally measurable mass

- No greater than 10,000,000/mL circulating tumor cells

- IgG levels at least 3 g/L

- No low-grade NHL transformed into intermediate- or high-grade NHL

- No symptomatic CNS lymphoma

- No bone marrow involvement only NOTE: A new classification scheme for adult
non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate",
or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- WHO 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 2.5 times upper limit of normal (ULN)

- Alkaline phosphatase less than 2.5 times ULN

Renal:

- Creatinine less than 2.5 times ULN

- BUN less than 2.5 times ULN

Cardiovascular:

- No severe cardiac disease (i.e., severe heart failure requiring symptomatic
treatment)

Pulmonary:

- No severe pulmonary disease

Other:

- No severe neurologic or psychiatric disease

- No severe metabolic disease

- Not pregnant

- Fertile patients must use effective contraception

- No prior malignancy within the past 5 years except nonmelanomatous skin cancer,
carcinoma in situ of the cervix, or other cancer curatively treated with surgical
therapy

- HIV negative

- No uncontrolled asthma or allergy requiring steroids

- No known hypersensitivity or prior anaphylactic reaction to murine proteins or any
component of study drug

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior rituximab

- No prior allogeneic or autologous peripheral blood stem cell transplantation

- Concurrent filgrastim (G-CSF) for stem cell mobilization allowed

Chemotherapy:

- See Disease Characteristics

- No prior anthracyclines or mitoxantrone

- No concurrent chemotherapy for stem cell mobilization

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Response as assessed by modified Lexcor criteria after induction therapy

Safety Issue:

No

Principal Investigator

M. H. J. Van Oers, MD

Investigator Affiliation:

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Authority:

United States: Federal Government

Study ID:

CDR0000067393

NCT ID:

NCT00004179

Start Date:

May 1999

Completion Date:

Related Keywords:

  • 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
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

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