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

July 13, 2018 updated by: Weill Medical College of Cornell University

A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives

  1. Efficacy: The primary objective (primary endpoint) is to determine the rate of response (partial or complete response) at week 16 (± 2) post-treatment in both pilot arms: the high dose Rituximab (or HDR) group (750 mg/m2 x 4) and the group treated with a regimen combining standard doses of Rituximab with CVP (R-CVP.) A complete response (CR) will be a platelet count increase ³ 150,000/mL on two consecutive occasions one week apart, without any other therapy. A partial response will be considered if the platelet count increases between 50 and 150,000/mL.
  2. Safety: To assess and compare the incidence of moderate and severe adverse-events including the number and type of infections in both arms of the study using Genentech standard safety monitoring and serious adverse event (SAE) reporting.

Secondary Objectives

  1. To compare the response rate in the 2 treatment arms in the "Rituximab non-responders" sub group (see 4.1 for definition)
  2. To compare the response rate in the 2 treatment arms in the " Rituximab relapsers" subgroup
  3. To assess the mean duration of response (PR or CR) in the 2 treatment arms.
  4. To evaluate the duration of very low to absent peripheral blood B cells in the two treatment arms.
  5. To assess the incidence of hypogammaglobulinemia (IgG and/or IgM level < ½ of lower limit of normal for age) and white blood counts in the two arms.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University Division of Pediatric Hematology-Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.
  • Have a platelet count of < 30,000/ul on two separate occasions 1-2 weeks apart within the past month prior to the inclusion.
  • 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U2735S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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