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

September 14, 2005
March 11, 2011
June 2005
November 2010   (final data collection date for primary outcome measure)
chronic GVHD incidence [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Chronic GVHD
Complete list of historical versions of study NCT00186628 on ClinicalTrials.gov Archive Site
  • Relapse [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • nonrelapse mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Relapse, non-relapse mortality
Not Provided
Not Provided
 
Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
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

To determine if Rituximab administered after allogeneic transplantation decreases the incidence of chronic GvHD

To test if prophylactic Rituximab given to 35 patients 60-90 days after allogeneic transplantation will prevent chronic Graft-versus-Host Disease

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Mast-Cell
  • 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
Not Provided
Arai S, Sahaf B, Narasimhan B, Chen GL, Jones CD, Lowsky R, Shizuru JA, Johnston LJ, Laport GG, Weng WK, Benjamin JE, Schaenman J, Brown J, Ramirez J, Zehnder JL, Negrin RS, Miklos DB. Prophylactic rituximab after allogeneic transplantation decreases B-cell alloimmunity with low chronic GVHD incidence. Blood. 2012 Jun 21;119(25):6145-54. doi: 10.1182/blood-2011-12-395970. Epub 2012 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2010
November 2010   (final data collection date for primary outcome measure)

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

Both
17 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00186628
BMT172, 96160, BMT172, PO1 CA 49605
Yes
David Miklos, Stanford University School of Medicine
Stanford University
The Leukemia and Lymphoma Society
Principal Investigator: David Miklos Stanford University
Stanford University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP