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

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Biogen
• Treatments: Antibodies, Monoclonal; Rituximab

Criteria

Inclusion Criteria:

1. 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.

2. 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).

3. Signed informed consent

4. Age >/= 18 years

5. Expected survival >/= 3 months

6. Pre-study Zubrod performance status of 0, 1, or 2

7. 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.

8. Female patients who are not pregnant or lactating

9. Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician)

10. 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

11. 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.)

12. Patient should have at least one lesion measuring >/= 2 cm in a single dimension.

Exclusion Criteria:

1. Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.

2. Platelet count< 100,000 cells/mm^3.

3. Presence of hypocellular bone marrow.

4. Patients with history of failed stem cell collection.

5. Prior radioimmunotherapy

6. Presence of Central Nervous System (CNS) lymphoma

7. Patients with HIV.

8. Patients with pleural effusion

9. Patients with abnormal liver function: total bilirubin > 2.0 mg/dL

10. Patients with abnormal renal function: serum creatinine > 2.0 mg/dL

11. Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)

12. 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.

13. Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives

14. Major surgery, other than diagnostic surgery, within four weeks

15. Evidence of transformation in the latest biopsy