Clinical trial · Interventional
Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma
Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no information
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| prednisolone | Drug | Prednisolone | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
| yttrium Y 90 ibritumomab tiuxetan | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single group
- interventionNames
- Biological: rituximab
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: prednisolone
- Drug: vincristine sulfate
- Radiation: yttrium Y 90 ibritumomab tiuxetan
Primary outcomes (1)
- measure
- Overall response rate, including combined complete response and partial response
Secondary outcomes (4)
- measure
- Time to disease progression
- measure
- Time to next treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 radioimmunotherapyReferences
Publications (1)
- DERIVEDIllidge TM, McKenzie HS, Mayes S, Bates A, Davies AJ, Pettengell R, Stanton L, Cozens K, Hampson G, Dive C, Zivanovic M, Tipping J, Gallop-Evans E, Radford JA, Johnson PW. Short duration immunochemotherapy followed by radioimmunotherapy consolidation is effective and well tolerated in relapsed follicular lymphoma: 5-year results from a UK National Cancer Research Institute Lymphoma Group study. Br J Haematol. 2016 Apr;173(2):274-82. doi: 10.1111/bjh.13954. Epub 2016 Feb 5. PMID 26849853