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| ID | Type | Description | Link |
|---|---|---|---|
| BMTGG-NSH-807 |
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| Name | Class |
|---|---|
| Blood and Marrow Transplant Group of Georgia | OTHER |
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RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before the transplant and tacrolimus and methotrexate after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with cyclophosphamide, busulfan, and fludarabine works in treating patients with hematological cancer or kidney cancer undergoing donor stem cell transplant.
OBJECTIVES:
OUTLINE:
Blood samples are collected periodically for pharmacokinetic studies of anti-thymocyte globulin and PCR analysis for chimerism.
After completion of study therapy, patients are followed periodically for up to 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG, Cytoxan, Bu/Flu based Allogeneic Transplant | Experimental | All patients will receive an ATG, Cyclosphosphamide, Busulfan and Fludarabine based Allogeneic Transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | Anti-Thymocyte Globulin (ATG) is commercially available. The 1st vial contains 25 mg ATG, and the 2nd vial contains > 5 mL SWFI diluent. Ampuls must be refrigerated (2º C - 8º C). Do not freeze. Reconstitute 25 mg vial with diluent provided by manufacturer. Roll vial gently to dissolve powder. Use contents of vial within 4 hours. Dilute dosage to a final concentration of 0.5 mg/mL in 0.9% sodium chloride injection or 5% dextrose injection. Gently invert admixture 1-2 times to mix. Use admixture solution immediately. Infuse the 1st dose over at least 6 hours, and subsequent doses over at least 4 hours. Infuse through a 0.22 micron in-line filter. Premeds include acetaminophen 650 mg PO, diphenhydramine 25-50 mg PO/IV, and methyprednisolone 1mg/kg at the initiation and half-way through ATG administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism) | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | Day 90 |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Chronic myeloid leukemia (CML)
Chronic lymphocytic leukemia meeting one of the following criteria:
Non-Hodgkin lymphoma (NHL) meeting one of the following criteria:
Indolent NHL
Aggressive NHL
Multiple myeloma
Durie-Salmon stage II or III disease
Acute myeloid leukemia or acute lymphocytic leukemia
In CR (defined as < 5% blasts in bone marrow and no circulating blasts) AND has any of the following poor prognostic features:
Renal cell carcinoma
Myelodysplastic syndromes
Myeloproliferative disease
Hodgkin lymphoma
No clinical evidence of active CNS involvement
Available 6/6 allele match (i.e., HLA-A, B, DRβ1)matched related donor
PATIENT CHARACTERISTICS:
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| Name | Affiliation | Role |
|---|---|---|
| Asad Bashey, MD, PhD | Blood and Marrow Transplant Group of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9015211 | Background | Rao SS, Peters SO, Crittenden RB, Stewart FM, Ramshaw HS, Quesenberry PJ. Stem cell transplantation in the normal nonmyeloablated host: relationship between cell dose, schedule, and engraftment. Exp Hematol. 1997 Feb;25(2):114-21. | |
| 9108426 | Background | Storb R, Yu C, Wagner JL, Deeg HJ, Nash RA, Kiem HP, Leisenring W, Shulman H. Stable mixed hematopoietic chimerism in DLA-identical littermate dogs given sublethal total body irradiation before and pharmacological immunosuppression after marrow transplantation. Blood. 1997 Apr 15;89(8):3048-54. |
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29 patients signed consent for this study. 2 patients were initially screen failures but eventually were determined eligible & were treated on study. 1 patient was considered a screen failure due to having an ineligible donor. One patient had progressive disease and one patient had compliance-related issues prohibiting them from particiapting.
24 patients were enrolled between 4/20/2007 and 5/3/2010. Patients who were undergoing transplant at Northside Hospital were potentially eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| busulfan | Drug | Commercially available in 60 mg/10 mL ampuls. Dilute busulfan injection in 0.9% sodium chloride injection or dextrose 5% in water. The dilution volume should be 10 times the volume of busulfan injection, ensuring that the final concentration of busulfan is ≥ 0.5 mg/mL. Store unopened ampuls at 2º C to 8º C. The diluted solution is stable for up to 8 hours at room temperature (25º C) but the infusion must also be completed within that 8-hour time frame. Dilution of busulfan injection in 0.9% sodium chloride is stable for up to 12 hours under refrigeration (2º C to 8º C) but the infusion must also be completed within that 12-hour time frame. IV Bu should be administered via a central venous catheter as a 2-hour infusion every 6 hours for 2 consecutive days for a total of 8 doses. |
|
| cyclophosphamide | Drug | Cyclophosphamide is commercially available. Cyclophosphamide for injection is available in 2000 mg vials which are reconstituted with 100 ml sterile water for injection. The concentration of the reconstituted product is 20 mg/ml. The calculated dose will be diluted further in 250-500 ml of Dextrose 5% in water. Reconstituted solutions of lyophilized cyclophosphamide are chemically and physically stable for 24 hours at room temperature or for 6 days in the refrigerator. Specific temperatures are not provided by the manufacturer. Reconstitution of cyclophosphamide with bacteriostatic water containing benzyl alcohol preservative may result in decomposition. Each dose will be infused over 1-2 hr (depending on the total volume). |
|
| fludarabine phosphate | Drug | Fludarabine is commercially available as a white, lyophilized powder. Each vial contains 50 mg of fludarabine, 50 mg of mannitol and sodium hydroxide to adjust pH. Intact vials should be stored under refrigeration. Reconstituted vials are stable for 16 days and solutions diluted in D5W or NS are stable for 48 hours at room temperature or under refrigeration. Fludarabine should be reconstituted with 2 mL of Sterile Water for Injection, USP. Each mL of the resulting solution will contain 25 mg of fludarabine, 25 mg of mannitol, and sodium hydroxide to adjust the pH to 7-8.5. The product should be further diluted for intravenous administration in 5% Dextrose for Injection, USP or in 0.9% Sodium Chloride, USP. Fludarabine will be administered as an IV infusion over 30 minutes. |
|
|
| methotrexate | Drug | Commercially available for injection in 2 mL (2.5 mg/mL), 2 mL, 4 mL, 8 mL, 10 mL (25 mg/mL) vials, or 20 mg, 25 mg, 50 mg, or 100 mg vials for reconstitution. Vials requiring reconstitution should be reconstituted to a concentration of 25 mg/mL. Intact vials should be stored at room temperature and protected from light. Once opened, solutions containing preservatives are stable for 4 weeks at room temperature and up to 3 months refrigerated. Administer via slow IV push. |
|
|
| tacrolimus | Drug | Tacrolimus is commercially available as an injection (5 mg/mL; 1 mL ampuls) and as oral capsules (1 mg and 5 mg). Tacrolimus injection must be diluted prior to IV infusion with 0.9% sodium chloride or 5% dextrose injection to a concentration of 4-20 μg/mL. Solutions should be prepared in non-PVC plastic or glass. Tacrolimus injection and diluted solutions of the drug should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Oral therapy should be started as possible as per protocol and 8 to 12 hours after stopping intravenous therapy. Oral doses will be administered twice a day. Store tacrolimus capsules and injection at controlled room temperature, 15-30º C (59-86º F). |
|
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| nonmyeloablative allogeneic HSCT | Procedure | As demonstrated by groups in Houston, Jerusalem & Seattle, RICT has been used to treat hematologic & solid malignancies with related & unrelated donors. Although adequate comparisons of RICT versus ablative alloHCT remain to be reported, the studies of RICT so far suggest that TRM is generally less than would be expected for similar patients undergoing ablative alloHCT; incidence of acute & chronic GVHD is similar or less than ablative alloHCT; autologous hematopoietic recovery is more common than seen following ablative alloHCT if graft failure occurs; powerful GVT effects can be seen but are dependent on high levels of donor T-cell chimerism and RICT are less effective than ablative alloHCT in controlling aggressive malignancies |
|
| T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%) | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | 180 days |
| Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease | number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. | Day 100 |
| Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD) | Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. | 2 years |
| Non-relapse Mortality (NRM) at Day 180 Post-transplantation | non-relapse mortality refers to the death of a patient for causes other than relapsed disease. | Day 180 |
| Disease-free Survival (DFS) at 24 Months | Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted. | 24 months |
| Overall Survival (OS) at 24 Months | Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease. | 24 months |
| 9192777 | Background | Giralt S, Estey E, Albitar M, van Besien K, Rondon G, Anderlini P, O'Brien S, Khouri I, Gajewski J, Mehra R, Claxton D, Andersson B, Beran M, Przepiorka D, Koller C, Kornblau S, Korbling M, Keating M, Kantarjian H, Champlin R. Engraftment of allogeneic hematopoietic progenitor cells with purine analog-containing chemotherapy: harnessing graft-versus-leukemia without myeloablative therapy. Blood. 1997 Jun 15;89(12):4531-6. |
| 9446633 | Background | Slavin S, Nagler A, Naparstek E, Kapelushnik Y, Aker M, Cividalli G, Varadi G, Kirschbaum M, Ackerstein A, Samuel S, Amar A, Brautbar C, Ben-Tal O, Eldor A, Or R. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood. 1998 Feb 1;91(3):756-63. |
| 11369628 | Background | McSweeney PA, Niederwieser D, Shizuru JA, Sandmaier BM, Molina AJ, Maloney DG, Chauncey TR, Gooley TA, Hegenbart U, Nash RA, Radich J, Wagner JL, Minor S, Appelbaum FR, Bensinger WI, Bryant E, Flowers ME, Georges GE, Grumet FC, Kiem HP, Torok-Storb B, Yu C, Blume KG, Storb RF. Hematopoietic cell transplantation in older patients with hematologic malignancies: replacing high-dose cytotoxic therapy with graft-versus-tumor effects. Blood. 2001 Jun 1;97(11):3390-400. doi: 10.1182/blood.v97.11.3390. |
| 12599934 | Background | Champlin R, Khouri I, Anderlini P, De Lima M, Hosing C, McMannis J, Molldrem J, Ueno N, Giralt S. Nonmyeloablative preparative regimens for allogeneic hematopoietic transplantation. Biology and current indications. Oncology (Williston Park). 2003 Jan;17(1):94-100; discussion 103-7. |
| 12910373 | Background | Platzbecker U, Ehninger G, Schmitz N, Bornhauser M. Reduced-intensity conditioning followed by allogeneic hematopoietic cell transplantation in myeloid diseases. Ann Hematol. 2003 Aug;82(8):463-468. doi: 10.1007/s00277-003-0680-7. Epub 2003 Jun 21. |
| 15125701 | Background | Storb R. Non-myeloablative allogeneic transplantation -- state-of-the-art. Pediatr Transplant. 2004 Jun;8 Suppl 5:12-8. doi: 10.1111/j.1398-2265.2004.00189.x. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | only 15 of the patients treated on study had Day 30 chimerism results. | Posted | Number | participants | Day 30 |
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| Secondary | T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism) | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | 20 of the patients treated on this study had Day 90 chimerism drawn. | Posted | Number | participants | Day 90 |
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| Secondary | T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%) | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. | 20 of the patients treated on study had chimerism drawn on day 180. | Posted | Number | participants | 180 days |
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| Secondary | Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease | number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. | 23 patients were able to be analyzed for severe gvhd | Posted | Number | participants | Day 100 |
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| Secondary | Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD) | Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. | 23 patients were able to be analyzed for severe gvhd | Posted | Number | participants | 2 years |
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| Secondary | Non-relapse Mortality (NRM) at Day 180 Post-transplantation | non-relapse mortality refers to the death of a patient for causes other than relapsed disease. | 23 patients were able to be analyzed for NRM at 180 days | Posted | Number | participants | Day 180 |
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| Secondary | Disease-free Survival (DFS) at 24 Months | Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted. | 23 patients were able to be analyzed for DFS at 24 months | Posted | Number | participants | 24 months |
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| Secondary | Overall Survival (OS) at 24 Months | Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease. | 23 patients were able to be analyzed for OS at 24 months | Posted | Number | participants | 24 months |
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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 | RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan | All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 & -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6 | 13 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Abcess | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Chemotherapy reaction | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Acute Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| GI Bleeding | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| hospitalization for high dose steroid management | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Altered Mental Status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal cramping | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| abdominal distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| agitation | Social circumstances | CTCAE (3.0) | Systematic Assessment |
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| Alk Phos | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| ALT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| altered mental status | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| ANC | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| anorexia/decreased appetite | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| anxiety | Social circumstances | CTCAE (3.0) | Systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| AST | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| BK virus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| blood in stool | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Clostridium difficile | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Chest discomfort | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| chest tightness | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| chest wall pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| chills | General disorders | CTCAE (3.0) | Systematic Assessment |
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| CMV | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| coarse breath sounds | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| creatinine | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Central venous catheter (CVC) discomfort | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
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| CVC erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| diaphoresis | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| diminished breath sounds | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| dizziness | General disorders | CTCAE (3.0) | Systematic Assessment |
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| drowsy | General disorders | CTCAE (3.0) | Systematic Assessment |
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| dry eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| eye irritation | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| eye redness | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| Facial flushing | General disorders | CTCAE (3.0) | Systematic Assessment |
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| fall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| flat affect | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| folliculitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| generalized pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastroesophogeal Reflux disease (GERD) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| headache | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hiccups | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| hip pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hyperbilirubinemia | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| hyperglycemia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypothyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| lethargy | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| lip lesion | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| lower extremity pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| MRSE | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| night sweats | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| nocturia | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| numbness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| oral sensitivity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peeling of skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| petechiae | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| poor appetite | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| post-nasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| prurutis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| restless | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| seasonal allergies | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| sinus congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| skin tenderness | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| swelling (hands and fingers) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| tachycradia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| taste alteration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| throat pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| thrush | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| tremors | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| unsteadiness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary hesitancy | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| urinary urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| WBC (leukocytes) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weight gain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Asad Bashey, MD, PhD, Principal Investigator | Blood and Marrow Transplant Group of Georgia | 404-255-1930 | abashey@bmtga.com |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007680 | Kidney Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D000013 | Congenital Abnormalities |
| D002292 | Carcinoma, Renal Cell |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D055728 | Primary Myelofibrosis |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D006689 | Hodgkin Disease |
| D015473 | Leukemia, Promyelocytic, Acute |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D002051 | Burkitt Lymphoma |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D007119 | Immunoblastic Lymphadenopathy |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D015470 | Leukemia, Myeloid, Acute |
| D016399 | Lymphoma, T-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D015448 | Leukemia, B-Cell |
| D000072281 | Lymphadenopathy |
Not provided
Not provided
| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| D008727 | Methotrexate |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided
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