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

NCT00637832 | Terminated Phase 2

• 5 other identifiers: CDR0000588042USCTU-SCHRIFT-06-DOG05-44USCTU-RHM-CAN05422007-000222-51EU-20819
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

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 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

Lymphoma

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate, including combined complete response and partial response

Secondary Outcomes (4)

• Time to disease progression

• Time to next treatment

• Response duration in patients with responding disease

• Safety

Study Arms (1)

single group

EXPERIMENTAL

Biological: rituximab; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: prednisolone; Drug: vincristine sulfate; Radiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximab BIOLOGICAL

single group

cyclophosphamide DRUG

single group

doxorubicin hydrochloride DRUG

single group

prednisolone DRUG

single group

vincristine sulfate DRUG

single group

yttrium Y 90 ibritumomab tiuxetan RADIATION

single group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (5)

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Saint Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• Illidge 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 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Prednisolone; Vincristine; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Tim Illidge

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 18, 2008
• Study Start: April 1, 2008
• Primary Completion: January 6, 2015
• Study Completion: January 6, 2015
• Last Updated: January 6, 2022

Record last verified: 2021-12

Locations

GB (5)