Status:
TERMINATED
Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma
Lead Sponsor:
University of Southampton
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 o...
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00637832
Start Date
April 1 2008
End Date
January 6 2015
Last Update
January 6 2022
Active Locations (5)
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1
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
2
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
3
Dorset Cancer Centre
Poole Dorset, England, United Kingdom, BH15 2JB
4
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD