Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 1 | 7 | 16 | ||
| 2 | 10 | history of severe immediate hypersensitivity reaction to cyclophosphamide or | 5 | fludarabine phosphate | 3 |
| 3 | 3 | history of severe immediate hypersensitivity reaction to cyclophosphamide | 4 | cladribine | 2 |
| 4 | 5 | history of hypersensitivity to cyclophosphamide | 3 | chemotherapy | 2 |
| 5 | 4 | contraindication to cyclophosphamide or | 2 | phosphate fludarabine | 2 |
| 6 | 14 | or | 2 | or campath within 12 months prior to study entry | 2 |
| 7 | 21 | any known contraindications to cyclophosphamide | 2 | . | 1 |
| 8 | 36 | able to tolerate high dose cyclophosphamide | 2 | interleukin 2 | 1 |
| 9 | 2 | patients with a known hypersensitivity to treosmcLfan and / or | 1 | or il 2 . | 1 |
| 10 | 7 | subject has known sensitivity and immediate hypersensitivity to any components of amg 119 or conditioning regimen cyclophosphamide and | 1 | or aldesleukin | 1 |
| 11 | 9 | prior use of clofarabine or | 1 | fludarabine phosphate or bendamustine based regimen r n progression within 24 months of a fludarabine and alkylator combination regimen r n progression after any regimen in the presence of deletion del 17p or mutated tumor protein p53 tp53 r n persons with high grade lymphoma transformation | 1 |
| 12 | 11 | previously known hypersensitivity to any of the agents used in this study known sensitivity to busmcLfan or | 1 | bendamustine | 1 |
| 13 | 13 | washout period of at least 14 days after any approved or experimental tumor directed therapy prior to start of cyclophosphamide and | 1 | flu and busmcLfan r n fractionated total body irradiation tbi and cyclophosphamide r n busmcLfan and cyclophosphamide | 1 |
| 14 | 16 | received any investigational agent within the 14 days before the start of study treatment 1st dose of | 1 | fludarabine phosphate or fail to have a complete or partial response after therapy with a regimen containing fludarabine or another nucleoside analog e . g . cladribine 2 cda | 1 |
| 15 | 20 | b cell b chronic lymphocytic leukemia cll r n relapse / progression after two previous regimens r n no response or progression = < 6 months after | 1 | or another nucleoside analog | 1 |
| 16 | 23 | patients who relapse after receiving a one or more courses of | 1 | or il 2 | 1 |
| 17 | 24 | must receive a myeloablative or reduced intensity conditioning regimen for stem cell transplant sct as defined by the center for international blood and bone marrow transplant research cibmtr r n cyclophosphamide cy and single dose total body irradiation r n | 1 | based therapy within 6 months of enrollment | 1 |
| 18 | 26 | chronic lymphocytic leukemia / small lymphocytic lymphoma cll / sll must be refractory to | 1 | and cyclophosphamide | 1 |
| 19 | 27 | pentostatin or experience disease relapse within 12 months after completing therapy with a regimen containing | 1 | fludarabine phosphate conditioning regimen and patients toxicities must have recovered to a grade 1 or less except for toxicities such as alopecia or vitiligo | 1 |
| 20 | 30 | history of allergic reactions to chemotherapy agents used in this protocol as part of lymphodepletion regimen | 1 | and high dose il 2 | 1 |
| 21 | 31 | a treatment regimen containing cytotoxic agents eg | 1 | / melphalan / alemtuzumab fludarabine / busmcLfan / alemtuzumab fludarabine / melphalan / atg fludarabine / busmcLfan / atg | 1 |
| 22 | 32 | pregnant women are excluded from this study females of child bearing potential must have a negative pregnancy test within 14 days of study treatment breastfeeding must be discontinued before beginning | 1 | based chemotherapy within 6 months | 1 |
| 23 | 33 | at least 14 days must have elapsed since any prior systemic therapy at the time the patient starts the cyclophosphamide and | 1 | or alemtuzumab based regimens . | 1 |
| 24 | 34 | with known hypersensitivity to treosmcLfan or | 1 | based therapy | 1 |
| 25 | 38 | t cell depletion with anti thymocyte globmcLin atg rabbit or horse or at least 30 mg of alemtuzumab total in the conditioning regimen acceptable conditioning regimens include but are not limited to | 1 | fludarabine phosphate and at least one other salvage regimen or 2 standard regimens r n if 17p deletion present one standard regimen is sufficient | 1 |
| 26 | 40 | prior treatment with | 1 | or another nucleoside analog e . g . cladribine 2 cda | 1 |
| 27 | 41 | considered inappropriate for | 1 | or another nucleoside analog containing regimen r n failed fcr or pentostatin / cyclophosphamide / rituximab pcr combination chemotherapy at any time point r n patients with novo or acquired 17p deletion cytogenetic abnormality patients shomcLd have received induction treatment but comcLd be transplanted in 1st cr | 1 |
| 28 | 42 | b lpl r n relapse / progression after | 1 | therapy based on either | 1 |
| 29 | 43 | patients with b cell cll or pll who r n failed to meet national cancer institute nci working group criteria 2 for complete or partial response after 2 cycles of therapy with regimen containing | 1 | cytarabine | 1 |
| 30 | 44 | pentostatin or with disease relapse within 12 months after completing therapy with a | 1 | / cyclophosphamide / rituximab fcr or has preference to not receive chemotherapy . | 1 |
| 31 | 45 | not a candidate for | 1 | clofarabine or cloretazine within 12 months preceding the asci treat ment . | 1 |
| 32 | 46 | patient must have documented cr or crp after 1 or 2 cycles of | 1 | / busmcLfan / lymphocyte immune globmcLin atgam / thymoglobmcLin thymo | 1 |
| 33 | 47 | previously untreated patients who have been counseled on approved alternative therapeutic options . not a candidate for | 1 | phosphate fludarabine 120 to 180 mg / m 2 melphalan hydrochloride melphalan = < 150 mg / m 2 r n flu / bu fludarabine 120 to 180 mg / m 2 busmcLfan = < 8 mg / kg orally or = < 6 . 4 mg / kg intravenously | 1 |
| 34 | 49 | the patient has received | 1 | / melphalan where fludarabine is > = 90 mg / m 2 intravenously iv total dose and melphalan is 100 140 mg / m 2 iv total dose exact logistics of administration are at the discretion of institutional standard r n fludarabine / busmcLfan where fludarabine is > = 90 mg / m 2 iv total dose and busmcLfan = 6 . 4 mg / kg iv total dose exact logistics of administration are at the discretion of institutional standard r n fludarabine / busmcLfan where fludarabine is > = 90 mg / m 2 iv total dose and busmcLfan is dosed to achieve area under the curve auc of 4000 umol / min based on a pharmacokinetics determined from a test dose exact logistics are at the discretion of institutional standard r n gvhd prophylaxis is comprised of tacrolimus / short course methotrexate as defined by tacrolimus started prior to day 0 of hsct and methotrexate given after hsct on days 1 3 and 6 / 11 at a dose of 5 10 mg / m 2 iv exact logistics are at the discretion of the treating institution | 1 |
| 35 | 54 | subjects will be eligible if their planned conditioning regimen for allogeneic hct consists of one of the two following standard reduced intensity conditioning regimens r n flu / mel | 1 | NA | |
| 36 | 55 | dr and c who pass institutional standard to serve as a peripheral blood stem cell donor r n donor grafts must be granmcLocyte colony stimmcLating factor g csf mobilized peripheral blood stem cells with dose and apheresis logistics at the discretion of institutional standard r n conditioning therapy will be one of the following 3 options r n | 1 | NA |