Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas

NCT00493454 | Terminated Phase 2 Results

• 1 other identifier: 2005-0571
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• Overall Response Rate (ORR). Secondary Objectives:
• The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders.
• Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR).
• Time to next anticancer therapy (TTNT).

Conditions

Lymphoma

Keywords

Indolent Lymphoma; Extranodal Marginal; Nodal Marginal Zone; Splenic Marginal; MALT Type; Zevalin; Ibritumomab Tiuxetan; Rituximab

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.

  Evaluation 4 weeks after administration of Zevalin up to 3 years

Study Arms (1)

Ibritumomab tiuxetan + Rituximab

EXPERIMENTAL

Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.

Drug: Zevalin; Drug: Rituximab; Drug: ^111 In Ibritumomab Tiuxetan

Interventions

Zevalin DRUG

.3 mCi IV Over 10 Minutes x 1 Day

Also known as: Ibritumomab Tiuxetan

Ibritumomab tiuxetan + Rituximab

Rituximab DRUG

250 mg/m\^2 IV Over 6 to 8 Hours

Ibritumomab tiuxetan + Rituximab

^111 In Ibritumomab Tiuxetan DRUG

1.6 mg IV Over 10 Minutes x 1 Day

Also known as: Indium-111

Ibritumomab tiuxetan + Rituximab

Eligibility Criteria

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

You may qualify if:

• No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.
• Previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/- villous lymphocytes).
• Signed informed consent
• Age \>/= 18 years
• Expected survival \>/= 3 months
• Pre-study Zubrod performance status of 0, 1, or 2
• Acceptable hematologic status within two weeks prior to patient registration, including: (a) Absolute neutrophil count (\[segmented neutrophils + bands\] \* total white blood count (WBC)) \>/= 1,500/mm\^3; (b) Platelet counts \>/= 100,000/mm\^3.
• Female patients who are not pregnant or lactating
• Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician)
• Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed
• Patients determined to have \< 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (This criteria must be strictly met for adequate patient safety.)
• Patient should have at least one lesion measuring \>/= 2 cm in a single dimension.

You may not qualify if:

• Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.
• Platelet count\< 100,000 cells/mm\^3.
• Presence of hypocellular bone marrow.
• Patients with history of failed stem cell collection.
• Prior radioimmunotherapy
• Presence of Central Nervous System (CNS) lymphoma
• Patients with HIV.
• Patients with pleural effusion
• Patients with abnormal liver function: total bilirubin \> 2.0 mg/dL
• Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL
• Patients who have received prior external beam radiation therapy to \> 25% of active bone marrow (involved field or regional)
• Patients who have received short-acting growth factor support (Leukine, Neupogen, Procrit) within 2 weeks prior to treatment or long-acting growth-factor support (Aranesp), Neulasta) within 4 weeks prior to treatment.
• Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
• Major surgery, other than diagnostic surgery, within four weeks
• Evidence of transformation in the latest biopsy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Biogen: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center Official Web Site

MeSH Terms

Conditions

Lymphoma

Interventions

ibritumomab tiuxetan; Rituximab; Indium-111

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Felipe Samaniego, MD / Associate Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Felipe Samaniego, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 28, 2007
• Study Start: April 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-05

Locations

US (1)