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Study of Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00774202
First Posted: October 17, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Biogen
Genentech, Inc.
Information provided by (Responsible Party):
James B. Bussel, Weill Medical College of Cornell University
  Purpose
This study is designed to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respond to or relapsed after standard doses of Rituxan. Patients eligible for this protocol will be stratified into two subgroups according to their initial response to Rituxan.

Condition Intervention Phase
Immune Thrombocytopenic Purpura Drug: Rituxan and Cyclophosphamide, Vincristine and Prednisone Drug: Higher Dose of Rituximab Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Rand. Trial Comp Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine, and Prednisone) in Patients With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment

Resource links provided by NLM:


Further study details as provided by James B. Bussel, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Our primary objective is therefore to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP [ Time Frame: 2 years ]
    Our primary objective is therefore to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respond to or relapsed after standard doses of Rituxan. Patients eligible for this protocol will be stratified into two subgroups according to their initial response to Rituxan


Secondary Outcome Measures:
  • efacy [ Time Frame: 2 years ]
    The goal is to see if there are major differences between the two arms for each group in term of efficacy and of toxicity. In addition, there may be differences for the two merged subgroups within each group

  • Effacy of the 2 groups [ Time Frame: 2 years ]
    The goal is to see if there are major differences between the two arms for each group in term of efficacy and of toxicity. In addition, there may be differences for the two merged subgroups within each group


Other Outcome Measures:
  • Safety and effacy [ Time Frame: 2 years ]

Enrollment: 17
Study Start Date: November 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Dose of Rituxan and CVP

'Standard Dose of Rituxan and CVP'

Interventions are as follows: Rituximab will be administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. However, the schedule of the infusions will be different than the usual one: Rather than administrating the 4 doses once weekly, the first infusion will be given 5 days (± 3 days) prior to the first CVP, and the following 3 infusions will be given on the same day as the 3 cycles of CVP.

Drug: Rituxan and Cyclophosphamide, Vincristine and Prednisone
'Rituxan and Cyclophosphamide, Vincristine and Prednisone' Interventions are as follows: Rituximab will be administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. However, the schedule of the infusions will be different than the usual one: Rather than administrating the 4 doses once weekly, the first infusion will be given 5 days (± 3 days) prior to the first CVP, and the following 3 infusions will be given on the same day as the 3 cycles of CVP.
Other Name: Rituximab
Active Comparator: Higher Dose of Rituximab
In this arm, Rituximab will be administered at a dose of 750 mg/m2 once a week x 4 consecutive weeks (4 infusions in total). We will perform EKG monitor tracings before, during and after Rituxan infusions. This will be a single-lead tracing that will allow us to look at issues such as the Q-T interval.
Drug: Higher Dose of Rituximab

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • We will allow patients who do not have 2 platelet counts < 30,000 on two separate occasions 1-2 weeks apart in the past month, as long as they have either Evan's Syndrome or autoimmune neutropenia (have hemoglobin < 10 g/dL and reticulocytes > 4%, or an absolute neutrophil count < 1.0 K/uL twice within 1 month)
  • Are age ≥ 10 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 a 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774202


Locations
United States, New York
525 East 68th Street
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Biogen
Genentech, Inc.
Investigators
Principal Investigator: James B Bussel, M.D. Weill Medical College of Cornell University
  More Information

Responsible Party: James B. Bussel, M.D. Professor of Pediatrics, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00774202     History of Changes
Other Study ID Numbers: 0301005964
First Submitted: October 15, 2008
First Posted: October 17, 2008
Last Update Posted: October 12, 2017
Last Verified: January 2017

Keywords provided by James B. Bussel, Weill Medical College of Cornell University:
Pts w/ Chronic ITP who have fail/relap after Rituxan rx

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Cyclophosphamide
Rituximab
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids