Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00107 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2226 | |||
| 2226.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P01CA078902 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II trial studies giving rituximab before and after a donor peripheral blood stem cell transplant in patients with B-cell lymphoma that does not respond to treatment (refractory) or has come back after a period of improvement (relapsed). Monoclonal antibodies, such as rituximab, can interfere with the ability of cancer cells to grow and spread. Giving rituximab before and after a donor peripheral blood stem cell transplant may help stop cancer from coming back and may help keep the patient's immune system from rejecting the donor's stem cells.
PRIMARY OBJECTIVES:
I. To determine the effect of addition of peri-transplant rituximab on relapse rate at 18 months after non-myeloablative allogeneic hematopoietic cell transplant (HCT) for cluster of differentiation (CD)20+ B-cell malignancies.
SECONDARY OBJECTIVES:
I. To determine overall and progression-free survival and non-relapse mortality.
II. To determine the incidence and severity of acute and chronic graft-versus-host disease (GVHD).
III. To determine the rate of graft rejection and graft failure.
IV. To determine the time to engraftment.
V. To determine the incidence of serious adverse events with the addition of rituximab.
VI. To evaluate the pharmacokinetics of rituximab in the setting of non-myeloablative allogeneic HCT.
VII. To describe donor and host polymorphisms of the FC gamma receptor IIIa (FCg RIIIA) and CD32 and evaluate their impact on disease response and relapse.
OUTLINE:
Patients receive rituximab intravenously (IV), pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 18 months and then annually for 5 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (rituximab pre- and post-transplant) | Experimental | Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Relapse Rate | Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated. | At 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 | Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD. aGVHD Stages Skin: a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Maloney | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31481800 | Derived | Shadman M, Maloney DG, Storer B, Sandmaier BM, Chauncey TR, Smedegaard Andersen N, Niederwieser D, Shizuru J, Bruno B, Pulsipher MA, Maziarz RT, Agura ED, Hari P, Langston AA, Maris MB, McSweeney PA, Storb R, Sorror ML. Rituximab-based allogeneic transplant for chronic lymphocytic leukemia with comparison to historical experience. Bone Marrow Transplant. 2020 Jan;55(1):172-181. doi: 10.1038/s41409-019-0660-8. Epub 2019 Sep 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Rituximab Pre- and Post-transplant) | Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| peripheral blood stem cell transplantation | Procedure | Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation |
|
|
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation |
|
| pharmacological study | Other | Correlative studies |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Through day +100 after transplant |
| Overall Survival and Progression-free Survival | Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant. | At 6 months and then every year thereafter, up to 18 months |
| Rate of Graft Rejection and Graft Failure | Number of patients experiencing graft rejection and/or graft failure | 18 Months |
| Time to Engraftment | Median time from transplant to engraftment. | 18 Months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Rituximab Pre- and Post-transplant) | Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Disease Relapse Rate | Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated. | Posted | Count of Participants | Participants | At 18 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 | Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD. aGVHD Stages Skin: a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death | Posted | Count of Participants | Participants | Through day +100 after transplant |
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival and Progression-free Survival | Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant. | Posted | Count of Participants | Participants | At 6 months and then every year thereafter, up to 18 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Rate of Graft Rejection and Graft Failure | Number of patients experiencing graft rejection and/or graft failure | Posted | Count of Participants | Participants | 18 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Time to Engraftment | Median time from transplant to engraftment. | Posted | Median | Full Range | Days | 18 Months |
|
|
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Rituximab Pre- and Post-transplant) | Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies | 5 | 63 | 15 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple Pulmonary Emboli | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Suspected Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Death Due to Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis and Tachycardia | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis, Respiratory Failure, Mental Status Change | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARDS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Diffuse Alveolar Hemorrhage | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Elevated Bilirubin | Hepatobiliary disorders | Systematic Assessment |
| ||
| Elevated Creatinine | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David G Maloney, MD PhD | Fred Hutch | dmaloney@fredhutch.org |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D064090 | Intraocular Lymphoma |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D012008 | Recurrence |
| D007943 | Leukemia, Hairy Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D008223 | Lymphoma |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|