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Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 16, 2005
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.
The Leukemia and Lymphoma Society
Information provided by:
Stanford University
To determine if Rituximab administered after allogeneic transplantation decreases the incidence of chronic GvHD

Condition Intervention Phase
Leukemia, Mast-Cell Procedure: nonmyeloablative allogeneic hematopoietic cell transplant Drug: Cixutumumab Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase II Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • chronic GVHD incidence [ Time Frame: 1.5 years ]

Secondary Outcome Measures:
  • Relapse [ Time Frame: 5 years ]
  • nonrelapse mortality [ Time Frame: 5 years ]

Enrollment: 36
Study Start Date: June 2005
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: nonmyeloablative allogeneic hematopoietic cell transplant
    TLI is administered ten times in 80cGy fractions on day -11 through day -7 and day -4 through day -1. TLI is administered from a 6 MeV linear accelerator (photon beam).
    Other Name: HSCT
    Drug: Cixutumumab
    10 mg/kg, IV
    Other Name: IMC-A12
    Drug: Paclitaxel
    80 mg/m2, IV
    Other Name: Taxol
Detailed Description:
To test if prophylactic Rituximab given to 35 patients 60-90 days after allogeneic transplantation will prevent chronic Graft-versus-Host Disease

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 76 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:(A) Patients age greater than 17 and less than 76. (B) CLL patients with unmutated IgG VH gene status are immediately eligible and patients with mutated IgG VH genes (>2% nucleotide change compared to somatic sequence) are eligible if they are considered appropriate by their HSCT physician. CLL patients in complete remission benefit most from allogeneic HSCT, and physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.

(C) MCL patients who their BMT physicians believe would benefit from allogeneic HSCT.

(D) Adequate renal (Cr < 2.4 mg/dl) and hepatic (Bilirubin < 3.0 mg/dl, AST < 100 IU) function. Patients with lab results in excess of these can be enrolled with approval of PI.

(E) Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.

(F) All subjects must provided written informed consent

Donor Inclusion Criteria (A) Genotypically or phenotypically HLA-identical. (B) Donor age < 75 unless cleared by institutional P.I (C) Capable of giving written, informed consent. (D) Donor must consent to PBSC mobilization with G-CSF and apheresis

Exclusion Criteria:(A) Patient age less than 18 or greater than 75 (B) Patient does not have a 9/10 or 10/10 HLA identical donor (high resolution molecular genotyping at HLA A, B, C and DrB1, and DQ) (C) Standard exclusions for any allogeneic transplantation including: i. Pregnancy or lactation ii. Serious uncontrolled infection iii. HIV seropositivity iv. Hepatitis B or C seropositivity v. Cardiac function: ejection fraction <40% or uncontrolled cardiac failure vi. Pulmonary: DLCO <50% predicted vii. Liver function abnormalities: elevation of bilirubin to >= 3 mg/dl and/or AST>100 viii. Renal: creatinine >2.4 ix. Karnofsky performance score <= 60% x. Patients with poorly controlled hypertension (SBP>150 or DBP>90 repeatedly). (D) Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody is an exclusion criterion. Previous Rituximab therapy is neither required, nor is it an exclusion criterion, but will be carefully assessed and correlated with outcome.

(E) Inability to comply with the allogeneic transplant treatment. (F) Uncontrolled CNS involvement with disease

Donor Exclusion Criteria (A) Identical twin (B) Any contra-indication to the administration of subcutaneous G-CSF at a dose of 16mg/kg/d for five consecutive days (C) Serious medical or psychological illness (D) Pregnant or lactating females (E) Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers.

(F) HIV seropositivity

  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): NCT00186628

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
The Leukemia and Lymphoma Society
Principal Investigator: David Miklos Stanford University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Miklos, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186628     History of Changes
Obsolete Identifiers: NCT00234013
Other Study ID Numbers: BMT172
96160 ( Other Identifier: Stanford Secondary IRB Approval Number )
BMT172 ( Other Identifier: Stanford University )
P01CA049605 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2005
First Posted: September 16, 2005
Last Update Posted: October 12, 2017
Last Verified: March 2011

Additional relevant MeSH terms:
Leukemia, Mast-Cell
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Mastocytosis, Systemic
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents