Phase II Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
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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 |
- chronic GVHD incidence [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- 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) |
-
Procedure: nonmyeloablative allogeneic hematopoietic cell transplant
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 |
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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:
|
Graft vs Host Disease Leukemia Leukemia, Mast-Cell Immune System Diseases Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid, Acute Leukemia, Myeloid Mastocytosis, Systemic Mastocytosis Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Paclitaxel |
Rituximab Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013