{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"22"},{"groupId":"OG004","value":"1"}]}],"title":"Complete Remission"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"0"}]}],"title":"Partial Response"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"28"},{"groupId":"OG003","value":"28"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"description":"Number of participants receiving pentostatin + rituximab and bendamustine + rituximab who achieve a CR +PR measured by the following response criteria. Complete remission is all of the following for at least 4 weeks: absolute neutrophil count ≥ 1500/mm\\^3, platelets ≥ 100,000/mm\\^3, hemoglobin ≥ 11g/dl, spleen non-palpable below the costal margin, or not below costal margin on computed tomography, and circulating hairy cell leukemia (HCL) cells either non-visible on Wright stain or \\< 1% by flow cytometry. Partial response is all of the following for at least 4 weeks: neutrophils ≥ 1,500/µL or 50% improvement over baseline, platelets ≥100,000/µL or 50% improvement over baseline, hemoglobin ≥ 11.0 g/dL or 50% improvement over baseline, ≥ 50% decrease in circulating malignant HCL count from the pretreatment baseline, ≥ 50% reduction in sum of products of perpendicular diameters or decrease to ≤ 2 cm in evaluable (\\> 2cm) lymphadenopathy.","groups":[{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 70 mg/m\\^2 for initial tolerability study (closed) Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles 6 participants to bendamustine 70 mg/m\\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.","id":"OG000","title":"Non-Randomized to 70 mg/m2 Bendamustine-Rituximab"},{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\\^2 for initial tolerability study (closed) Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 6 participants to bendamustine 90 mg/m\\^2/day, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated","id":"OG001","title":"Non-randomized to 90 mg/m^2 Bendamustine-Rituximab"},{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\\^2 Rituximab: 28 participants Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine:28 participants to bendamustine 90 mg/m\\^2/day, days 1 and 2 each cycle, days 1 and 2 each cycle Acetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.","id":"OG002","title":"Randomized to 90 mg/m^2 Bendamustine-Rituximab"},{"description":"Treatment Assignment Code 2 (TAC 2) Rituximab + Pentostatin\n\nPentostatin: 28 participants to pentostatin 4 mg/m\\^2 days 1 and 15 of each cycle.\n\nRituximab: Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles\n\nAcetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated.\n\nIntravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated.","id":"OG003","title":"Randomized to Pentostatin-Rituximab"},{"description":"Treatment Assignment Code 5 (TAC 5) Rituximab + Bendamustine at 90 mg/m\\^2 or Rituxan + Pentostatin After initial tolerability studies are completed. Non-randomize up to 4 total participants to Bendamustine and/or Pentostatin with Rituximab Rituximab 375 mg/m\\^2 on day 1, 15 for 6 x 28-day cycles Bendamustine: 1-4 participants to bendamustine 90 mg/m\\^2/day, days 1 and 2 each cycle Pentostatin 1-4 participants to pentostatin 4 mg/m\\^2 days 1 and 15 of each cycle.\n\nAcetaminophen: Treatment of infusion-related symptoms with acetaminophen is recommended.\n\nDiphenhydramine: Treatment of infusion-related symptoms with diphenhydramine is recommended.\n\nEpinephrine: Epinephrine should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nAntihistamines: Antihistamines should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nCorticosteroids: Corticosteroids should be available for immediate use in the event of a hypersensitivity reaction to Rituximab.\n\nBronchodilators: Additional treatment with bronchodilators may be indicated. Intravenous (IV) Saline: Additional treatment with intravenous (IV) saline may be indicated","id":"OG004","title":"Non-randomized to Bendamustine 90mg/m^2 or Pentostatin 4mg/m^2 With Rituximab"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"At end of treatment, approximately 6 months","title":"Number of Participants Receiving Pentostatin + Rituximab and Bendamustine + Rituximab Who Achieve a Complete Remission (CR) + Partial Response (PR)","type":"PRIMARY","unitOfMeasure":"Participants"}