Clinical trial · Interventional
Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab
Nonmyeloablative BMT With Post-transplant Cyclophosphamide, Rituximab and Optimized Donor Selection for B-cell Lymphomas
NCT00946023CI-TRIAL-00034583terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding was unavailable to complete the study as originally planned.
Summary
Brief summary (as posted)
This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation and rituximab works in treating patients with B-cell lymphoma or chronic lymphocytic leukemia who are undergoing an allogeneic (donor) bone marrow transplant. The type of bone marrow transplant is a less intensive or "mini" transplant using a relative as the bone marrow donor. The donated bone marrow stem cells may replace the patient's immune system cells and help destroy any remaining cancer (graft-versus-tumor effect). Patients undergoing this type of transplant often have more than one relative who could be a donor. The trial is also studying a new way of choosing amongst possible donors which might improve how the rituximab works.
Conditions
Conditions (4)
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 Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Bone Marrow Transplant (BMT) | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Mycophenolate Mofetil | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplant
- description
- Non-myeloablative allogeneic bone marrow transplant (BMT) with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD (graft vs host disease) prophylaxis. Rituximab will be given as post-transplant maintenance.
- interventionNames
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Radiation: Total body irradiation
- Drug: Tacrolimus
- Drug: Mycophenolate Mofetil
- Drug: Rituximab
- Biological: Allogeneic Bone Marrow Transplant (BMT)
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 1 year post-intervention
- description
- Percentage of participants alive and without relapse or disease progression.
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* Poor-risk CD20+, B-cell lymphoma, as follows:
* Low grade B-cell lymphoma that has failed at least two prior therapies (excluding single agent rituximab), or undergone histologic conversion (if histologic conversion, PR or CR is required):
1. Follicular grade 1 or 2 lymphoma
2. Follicular lymphoma not otherwise specified
3. Marginal zone (or MALT) lymphoma
4. Lymphoplasmacytic lymphoma / Waldenstrom's macroglobulinemia
5. Hairy cell leukemia
6. Small lymphocytic lymphoma / chronic lymphocytic leukemia (SLL/CLL)
7. Low grade B-cell lymphoma, unspecified
8. Nodular lymphocyte-predominant Hodgkin lymphoma
* Poor-risk small lymphocytic lymphoma or chronic lymphocytic leukemia, defined by a 17p deletion, 11q deletion, or histologic conversion (if histologic conversion, PR or CR is required)
* Aggressive B-cell non-Hodgkin's lymphoma that has failed at least one prior regimen of multiagent chemotherapy, is in PR (partial remission) or CR (complete remission), and patient is either ineligible for autologous hematopoietic BMT or autologous BMT is not recommended:
1. Follicular grade 3 lymphoma
2. Histoconversion of low-grade B-cell lymphoma (including SLL/CLL) to aggressive B-cell non-Hodgkin's lymphoma
3. Mantle cell lymphoma
4. Diffuse large B-cell lymphoma (excluding primary CNS \[central nervous system\] lymphoma)
5. "Gray zone" or composite lymphomas with combined features of primary mediastinal large B-cell and Hodgkin's lymphoma
6. Burkitt's lymphoma/leukemia
7. Atypical Burkitt's lymphoma/leukemia (high grade B-cell lymphoma, unclassified, including that with features intermediate between Burkitt's and diffuse large B-cell lymphoma)
* Must have a related donor who is at least HLA haploidentical
* Any previous BMT must have occurred at least 3 months prior
* Left ventricular ejection fraction at least 35%
* Bilirubin no more than 3.0 mg/dL (unless due to Gilbert's syndrome), and ALT (alanine aminotransferase) and AST (aspartate aminotransferase) no more than 5 x upper limit of normal
* FEV1 (forced expiratory volume in one second) and FVC (forced vital capacity) at least 40% of predicted
* Absence of uncontrolled infection
Exclusion Criteria:
* More than 20% involvement of bone marrow by chronic lymphocytic leukemia
* Active central nervous system lymphoma
* ECOG (Eastern Cooperative Oncology Group) performance status greater than 1 (2,3, and 4)
* HIV positive
* Pregnant or breastfeedingReferences
Publications (1)
- RESULTKanakry JA, Gocke CD, Bolanos-Meade J, Gladstone DE, Swinnen LJ, Blackford AL, Fuchs EJ, Huff CA, Borrello I, Matsui WH, Brodsky RA, Rosner GL, Shanbhag S, Luznik L, Jones RJ, Ambinder RF, Kasamon YL. Phase II Study of Nonmyeloablative Allogeneic Bone Marrow Transplantation for B Cell Lymphoma with Post-Transplantation Rituximab and Donor Selection Based First on Non-HLA Factors. Biol Blood Marrow Transplant. 2015 Dec;21(12):2115-2122. doi: 10.1016/j.bbmt.2015.07.012. Epub 2015 Jul 14. PMID 26183076