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DISEASE & TREATMENT SETTING

Rituxan Hycela: refractory Chronic Lymphocytic Leukemia (first-line) after prior therapy

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

1 INDICATIONS AND USAGE RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with: Follicular Lymphoma (FL) ( 1.1 ) Relapsed or refractory, follicular lymphoma as a single agent Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy Diffuse Large B-cell Lymphoma (DLBCL) ( 1.2 ) Previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens Chronic Lymphocytic Leukemia (CLL) ( 1.3 ) Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC) Limitations of Use: Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose of a rituximab product by intravenous infusion.

Broader topic: Chronic Lymphocytic Leukemia

Source population
Not part of this definition
Disease extent
refractory
Treatment line
first-line
Stage
Not part of this definition
Resectability
Not part of this definition
Biomarkers, prior therapy and derivation
molecular
    prior therapy
    1. class
      after first-line cyclophosphamide
      status
      required
    derivation status
    source-attested
    derivation note
    Scoped from the FDA approved indication for Rituxan Hycela (product label). Only dimensions stated in that wording are part of this definition.
    source wording
    1 INDICATIONS AND USAGE RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with: Follicular Lymphoma (FL) ( 1.1 ) Relapsed or refractory, follicular lymphoma as a single agent Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy Diffuse Large B-cell Lymphoma (DLBCL) ( 1.2 ) Previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens Chronic Lymphocytic Leukemia (CLL) ( 1.3 ) Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC) Limitations of Use: Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose of a rituximab product by intravenous infusion.

    Study evidence for this setting

    59 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

    NCT00040846 · Registry condition search · Scope: unclear

    Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

    5 outcome links · 6 safety-group records · 0 quality-of-life measures

    →

    NCT00049504 · Registry condition search · Scope: unclear

    Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer

    3 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00058240 · Registry condition search · Scope: unclear

    Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma

    3 outcome links · 2 safety-group records · 0 quality-of-life measures

    →

    NCT00075478 · Registry condition search · Scope: unclear

    Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

    6 outcome links · 2 safety-group records · 0 quality-of-life measures

    →

    NCT00089011 · Registry condition search · Scope: unclear

    Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by

    6 outcome links · 2 safety-group records · 0 quality-of-life measures

    →

    NCT00089076 · Registry condition search · Scope: unclear

    MDX-010 in Treating Patients With Recurrent or Refractory Lymphoma

    6 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00105001 · Registry condition search · Scope: unclear

    Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematolog

    5 outcome links · 3 safety-group records · 0 quality-of-life measures

    →

    NCT00118352 · Registry condition search · Scope: unclear

    Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant

    6 outcome links · 3 safety-group records · 0 quality-of-life measures

    →

    NCT00119392 · Registry condition search · Scope: unclear

    Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

    5 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00288067 · Registry condition search · Scope: unclear

    Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma

    2 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00290472 · Registry condition search · Scope: unclear

    CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

    3 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00309842 · Registry condition search · Scope: unclear

    Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

    6 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00387426 · Registry condition search · Scope: unclear

    Sunitinib in Treating Patients With Idiopathic Myelofibrosis

    1 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00408681 · Registry condition search · Scope: unclear

    Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant

    6 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00536601 · Registry condition search · Scope: unclear

    High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

    4 outcome links · 5 safety-group records · 0 quality-of-life measures

    →

    NCT00648739 · Registry condition search · Scope: unclear

    Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM

    6 outcome links · 7 safety-group records · 0 quality-of-life measures

    →

    NCT00711828 · Registry condition search · Scope: unclear

    Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle

    6 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00719888 · Registry condition search · Scope: unclear

    Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

    6 outcome links · 2 safety-group records · 0 quality-of-life measures

    →

    NCT00723099 · Registry condition search · Scope: unclear

    Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

    6 outcome links · 1 safety-group records · 0 quality-of-life measures

    →

    NCT00789776 · Registry condition search · Scope: unclear

    Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolim

    6 outcome links · 2 safety-group records · 1 quality-of-life measures

    →
    Source relationships and population-mapping limitations
    bindings
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice