Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

This study has been completed.
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186628
First received: September 14, 2005
Last updated: March 11, 2011
Last verified: March 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • nonrelapse mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   17 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00186628

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

No publications provided by Stanford University

Additional 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, BMT172, PO1 CA 49605
Study First Received: September 14, 2005
Last Updated: March 11, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia, Mast-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Mastocytosis, Systemic
Mastocytosis
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on September 16, 2014