A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone

NCT00161564 | Withdrawn Phase 2

• 1 other identifier: U2735S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare the efficacy and safety of higher doses of rituximab to a combination of standard doses of Rituxan + CVP (Cyclophosphamide, Vincristine, and Prednisone) in patients with chronic Idiopathic Thrombocytopenic Purpura (ITP who did not respond to or relapsed after standard doses of rituximab.

Conditions

Idiopathic Thrombocytopenic Purpura (ITP)

Keywords

Idiopathic Thrombocytopenic Purpura; ITP; Non-Malignant Hematology

Interventions

Rituximab DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible to participate in the study if they:
• Have chronic ITP19 (\> 6 months duration).
• Have received Rituximab a minimum of 3 months prior to entry.
• Have received no more than 2 courses of Rituximab at standard dose separated by a minimum of 12 weeks.
• Have not achieved a durable response to Rituximab, with platelet counts \< 30,000/ml when not supported by other treatment.
• Are age ≥ 12 years old.
• Had a splenectomy at least 60 days prior to study entry, or a contraindication to splenectomy.
• Give written informed consent.
• Use an effective means of contraception during treatment and for six months after completion of treatment.
• Have negative serum pregnancy test, for all women who are able to have children, within 14 days prior to study entry.

You may not qualify if:

• Male and female subjects will be ineligible to participate if they:
• Received prior treatment with cyclophosphamide within the last 3 months.
• Received prior treatment with \> 4 infusions of vinca alkaloids within the 6 months.
• Had previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years.
• Have an HIV infection.
• Have hepatitis Bs antigen positivity or active hepatitis C infection
• Have an absolute neutrophil count \< 1.000/mm3 at study entry (unless related to autoimmune neutropenia).
• Have a Hemoglobin level \< 10 g/dl other than caused by thalassemia trait, iron deficiency or autoimmune hemolytic anemia (patients with Evan's syndrome will not be excluded).
• Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL.
• Have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an AST or ALT level \> 3x upper limit of normal.
• Have active infection requiring antibiotic therapy within 7 days prior to study entry.
• Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug.
• Have had a prior severe reaction to Rituximab, leading to discontinuation of treatment.
• Have a New York Heart Classification III or IV heart disease.
• Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Weill Medical College of Cornell University Division of Pediatric Hematology-Oncology

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• James B Bussel, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2004
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

US (1)