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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01547 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.
You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can be a brother, sister or another family member or a compatible unrelated donor. The drugs and the stem cells will be given through a catheter (a small tube) placed under the collarbone. You may receive your treatment on an inpatient or outpatient basis. If treated on an inpatient basis, you will stay in the hospital during treatment and recovery, which can take 4 to 5 weeks even if there are no complications.
The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF (Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an injection under the skin. You will also need blood and platelet transfusions.
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
If the cancer grows and graft-versus-host disease is not present, you may be eligible to receive donor blood cells (lymphocytes) infused through the catheter. This may cause graft-versus-host disease and may help shrink the cancer. If the cancer grows and graft-versus-host disease is already present, then donor lymphocytes are not given.
Sometimes, the body rejects the donor cells; this reaction is called "graft rejection". Sometimes the donor cells attack the body, a reaction called graft-versus-host disease (GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions from occurring. These drugs are given through a vein or by mouth before and/or after the transplant.
You must stay in the Houston area for at least 100 days after the transplant. After 100 days, you must return to Houston every 3 months for 2 years for tests and checkups, then once a year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s), you will receive no further treatment.
This is an investigational study. The drugs used in this study are approved by the FDA and are commercially available. As many as 35 patients will take part in the study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fludarabine + Melphalan with PBPC | Experimental | Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | 25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( > 90% to < 100%); only traces of disease remains; 2) Significant improvement ( > 75% to < 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( > 50% to < 75%); 4) Some improvement ( > 25% to < 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by > 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one. | Response assessed pre-transplant and 100 days post transplant with follow up at 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Overall Survival (OS) Length | OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days. | Baseline to disease progression, followed up to 5 years post transplant |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chitra M. Hosing, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26416896 | Derived | Hosing C, Bassett R, Dabaja B, Talpur R, Alousi A, Ciurea S, Popat U, Qazilbash M, Shpall EJ, Oki Y, Nieto Y, Pinnix C, Fanale M, Maadani F, Donato M, Champlin R, Duvic M. Allogeneic stem-cell transplantation in patients with cutaneous lymphoma: updated results from a single institution. Ann Oncol. 2015 Dec;26(12):2490-5. doi: 10.1093/annonc/mdv473. Epub 2015 Sep 28. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: September 26, 2003 to November 05, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fludarabine + Melphalan With PBPC | Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fludarabine + Melphalan With PBPC | Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) | Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( > 90% to < 100%); only traces of disease remains; 2) Significant improvement ( > 75% to < 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( > 50% to < 75%); 4) Some improvement ( > 25% to < 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by > 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one. | Posted | Number | participants | Response assessed pre-transplant and 100 days post transplant with follow up at 1 year. |
|
Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
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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 | Fludarabine + Melphalan With PBPC | Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary graft failure with autologous reconstitution | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chitra M. Hosing, Professor, Stem Cell Transplantation | University of Texas (UT) MD Anderson Cancer Center | 1-877-MDA-6789 | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D014184 | Transplantation, Homologous |
| D016026 | Bone Marrow Transplantation |
| D033581 | Stem Cell Transplantation |
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| Melphalan | Drug | 70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant. |
|
| Allogeneic Transplant | Procedure | Allogeneic transplant given by vein after completion of Fludarabine and Melphalan. |
|
|
| Thymoglobulin | Drug | 2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fludarabine + Melphalan With PBPC |
Fludarabine 25 mg/m^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine & Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 & -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow. |
|
|
| Secondary | Average Overall Survival (OS) Length | OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days. | Baseline to disease progression, followed up to 5 years post transplant (assess at 100 days, every 3 months for 2 years, then once a year for at least 3 years) | Posted | Mean | Full Range | Days | Baseline to disease progression, followed up to 5 years post transplant |
|
|
|
| 0 |
| 33 |
| 33 |
| 33 |
| Cardiac Edema | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Cardiac Function | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| pericarditis | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
|
| fever | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| fluid overload: Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| rigors | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| flatulence | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Upper gastrointestinal disorder, GvHD | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| pain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| vomit | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| bladder | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| frequency, urine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| hemorrhagic cystitis | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| Acute Kidney Disease (renal disorder), dialysis | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| abdomen pain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| dysuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
|
| transaminitis | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment | Elevated transaminases alanine transaminase (ALT) and aspartate transaminase (AST) |
|
| increase T bilirubin | Investigations | CTCAE (2.0) | Systematic Assessment |
|
| infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| neutropenic fever | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| drowsiness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
|
| weakness, generalized | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| muscular wasting | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| myalgias | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| pain | General disorders | CTCAE (2.0) | Systematic Assessment |
|
| bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| hiccoups | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Acute Graft versus Host Disease | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D017690 | Cell Transplantation |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |