Clinical trial · Interventional
Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
Addition of Pre- and Post-Transplant Rituximab for Patients Undergoing Non-myeloablative Allogeneic Hematopoietic Cell Transplantation With Relapsed or Refractory CD20+ B-Cell Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (38)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Adult Acute Lymphoblastic Leukemia | Adult B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Childhood Acute Lymphoblastic Leukemia | Childhood B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Childhood Burkitt Lymphoma | Childhood Burkitt Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Childhood Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Childhood Immunoblastic Large Cell Lymphoma | Childhood Immunoblastic Lymphoma | ALIAS | 0.90 |
| Cutaneous B-cell Non-Hodgkin Lymphoma | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (rituximab pre- and post-transplant)
- description
- 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.
- interventionNames
- Biological: rituximab
- Procedure: peripheral blood stem cell transplantation
- Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Disease Relapse Rate
- timeFrame
- At 18 months
- description
- 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.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * With a diagnosis of CD20-expressing B-cell malignancy of any histologic type or grade for whom non-myeloablative allogeneic transplant is considered an appropriate treatment option * Who are enrolled on a non-myeloablative allogeneic HCT protocol employing total-body irradiation (TBI)-based conditioning of =\< 4.5 Gy, with or without fludarabine; this protocol may be used as an adjunct to the allogeneic arm of a tandem autologous/allogeneic transplant protocol, provided the allogeneic conditioning meets the above criteria * Receiving unmodified peripheral blood mononuclear cell graft products * With an appropriate related or unrelated donor; human leukocyte antigen (HLA)-haploidentical donors are excluded * Able to give informed consent (if \>= 18 years of age), or with a legal guardian capable of giving consent (if \< 18 years of age) Exclusion Criteria: * Ineligible for non-myeloablative allogeneic HCT * Receiving an HLA-haploidentical allograft * Who are fertile but unwilling to use contraception during and for at least 12 months after HCT * Females who are pregnant or breast-feeding
References
Publications (1)
- DERIVEDShadman 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. PMID 31481800