Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Antineoplastic Agents, Immunological

Immunologic Factors

Total nodal irradiation

Andreas Engert

R.-P. Mueller

This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.

The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

A Phase II Study of Rituximab Plus Low-Dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

University of Cologne

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Mycophenolic Acid

Tacrolimus

Mesna

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Calcineurin Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over approximately 30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants also undergo total nodal irradiation on day -1.

TRANSPLANT: Participants undergo T-Cell Receptor (TCR) alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg participant body weight (BW), patients may receive a second graft on day 1.

GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil orally twice a day (PO BID) on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the participant).

Fludarabine will be administered by IV over approximately 30 minutes for 4 days.

Fludarabine Phosphate

Given IV over 24 hours starting prior to cyclophosphamide

Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant

T Cell-Depleted Hematopoietic Stem Cell Transplantation

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant

Peripheral Blood Stem Cell Transplantation

Mycophenolate Mofetil

Given PO or IV ONLY if graft cell content is over 1 x 10\^5 cells/kg ideal BW of the patient

Given IV ONLY if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient

Vaishalee P Kenkre

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell and CD19 cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for peripheral blood stem cell transplant in relapsed lymphoma.

Assess incidence of acute Graft Versus Host Disease (GVHD), chronic GVHD, graft failure rate, treatment related mortality rate, progression free survival and overall survival of patients.

The stem cell product will be processed using an investigational Miltenyi cell selection device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that are more likely to cause GVHD.

TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma

A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation (HSCT) in Patients With Relapsed Lymphoma

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma.

The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported.

The number of participants with severe chronic GVHD by Day +180 will be reported.

Graft failure - defined as \< 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved.

Treatment-related mortality is defined as death from any cause other than disease progression.

Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow,

University of Wisconsin, Madison

Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years.

PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1.

TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1.

GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).

Peripheral Blood Stem Cell Transplant

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Vaishalee Kenkre

Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days

Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria

Number of Participants With Severe Chronic GVHD

Number of Participants With Graft Failure

Number of Participants With Treatment-related Mortality

Progression-free Survival

Overall Survival (OS)

PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over \~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1.

TRANSPLANT: Participants undergo T-Cell Receptor (TCR) alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10\^6 CD34+ cells/kg participant body weight (BW), Participants may receive a second graft on day 1.

GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil orally twice a day (PO BID) on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10\^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10\^5 cells/kg ideal BW of the patient).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma	NCT00147953	Non-Hodgkin's L...	Rituximab Total nodal irr...	18 Years -	University of Cologne
TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma	NCT02652468	Lymphoma	Fludarabine Pho... Mesna Cyclophosphamid... Total nodal irr... T Cell-Depleted... Allogeneic Hema... Peripheral Bloo... Mycophenolate M... Tacrolimus Rituximab	18 Years - 75 Years	University of Wisconsin, Madison

Spots Global Cancer Trial Database for total nodal irradiation