| ID | Type | Description | Link |
|---|---|---|---|
| 96160 | Other Identifier | Stanford Secondary IRB Approval Number | |
| BMT172 | Other Identifier | OnCore | |
| SPO | Other Identifier | Leukemia & Lymphoma Society | |
| P01CA049605 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
| National Cancer Institute (NCI) | NIH |
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To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of chronic graft-vs-host disease (cGvHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic Rituximab | Experimental | Rituximab will be infused after a non-myeloablative transplantation regimen of total lymphoid irradiation (TLI) + anti-thymoglobulin (ATG), with the intention of reducing chronic graft-vs-host disease (cGvHD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total lymphoid irradiation | Procedure | Total lymphoid irradiation (TLI) administered at 80cGy for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Graft-vs-Host Disease (cGvHD) | The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Relapse | Subjects who Relapsed following after Allogeneic HSCT | 4 years |
| Mortality | Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse. |
Not provided
Recipient Inclusion Criteria:
Between 18 and 76 years of age
Chronic lymphocytic leukemia (CLL):
(Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.)
Donor Inclusion Criteria:
Recipient Exclusion Criteria:
Donor Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Miklos | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16338616 | Background | Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004. | |
| 22563089 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prophylactic Rituximab | Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rituximab | Drug | Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses. |
|
|
| Anti-thymoglobulin, rabbit (ATG, rabbit ATG) | Drug | Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg. |
|
| Cyclosporine | Drug | Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates > 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week). |
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| Mycophenylate mofetil | Drug | Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete |
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| Filgrastim | Drug | Filgrastim provided as needed for neutrophil support |
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| Granisetron | Drug | Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI |
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| Solumedrol | Drug | Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG) |
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| Acetaminophen | Drug | Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC |
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| Diphenhydramine | Drug | Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC |
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| Hydrocortisone | Drug | Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC |
|
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| Day 100 and 1 year |
| Overall Survival | 4 years |
| Result |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prophylactic Rituximab | Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Patient Disease characteristics | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chronic Graft-vs-Host Disease (cGvHD) | The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955) | 35 total participants were analyzed. No data is available for the withdrawn participant. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Incidence of Relapse | Subjects who Relapsed following after Allogeneic HSCT | 35 total participants were analyzed. No data is available for the withdrawn participant. | Posted | Count of Participants | Participants | 4 years |
|
| |||||||||||||||||||||||||||
| Secondary | Mortality | Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse. | 35 total participants were analyzed. No data is available for the withdrawn participant. | Posted | Number | Participants | Day 100 and 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | 35 total participants were analyzed. No data is available for the withdrawn participant. | Posted | Number | 95% Confidence Interval | Percentage of participants by disease | 4 years |
|
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prophylactic Rituximab | Participants to receive total lymphoid irradiation + anti-thymoglobulin (TLI + ATG) then nonmyeloablative allogeneic stem cell transplantation, with prophylactic rituximab | 4 | 35 | 4 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptom - Headache | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Acute Graft vs Host Disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Affecting skin, liver and GI tract |
|
| Graft vs Host Disease | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Affecting skin, liver, kidney |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flu-like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Miklos, MD, PhD; Associate Professor of Medicine (Blood and Marrow Transplantation) | Stanford University Medical Center | 650-725-4626 | dmiklos@stanford.edu |
| ID | Term |
|---|---|
| D007946 | Leukemia, Mast-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D034721 | Mastocytosis, Systemic |
| D008415 | Mastocytosis |
| D000090362 | Mast Cell Activation Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C512542 | thymoglobulin |
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D017829 | Granisetron |
| D008776 | Methylprednisolone Hemisuccinate |
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| D006854 | Hydrocortisone |
| C038363 | hydrocortisone valerate |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D001685 | Biological Factors |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| unknown or Not Reported |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Mortality within 100 days, all causes |
| |||||
| Nonrelapse mortality within 1 year |
| |||||
| Relapse + mortality within 1 year |
|
|