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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.

Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily

Day -1: 200 centigray (cGy) in a single fraction

Total body irradiation

Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)

Mycophenolate Mofetil

Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV

Allogeneic Bone Marrow Transplant (BMT)

Yvette L Kasamon, MD

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.

This phase II for relapsed or refractory B-cell malignancies builds on the platform of nonmyeloablative, related-donor, HLA (human leukocyte antigen)-matched or HLA-haploidentical BMT with post-transplantation high-dose cyclosphosphamide administered for prophylaxis of graft-versus-host disease and graft rejection. Rituximab is added to the transplant regimen with the goal of augmenting anti-tumor activity. In patients with B-cell lymphomas, specific polymorphisms in the immunoglobulin Fc receptor have been associated with greater sensitivity to rituximab or rituximab-based therapies, translating in some series into higher response rates and improved progression-free survival. This raises the possibility of selecting donors who carry this permissive polymorphism. This trial identifies and selects donors who have the favorable polymorphism at FcgammaR3A-158, thereby potentially conferring greater sensitivity to rituximab in the host after BMT.

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

Percentage of participants alive and without relapse or disease progression.

Percentage of participants alive with and without relapse.

Percentage of participants alive with relapse or disease progression.

Percentage of participants who died due to BMT-related reasons.

Percentage of participants who experienced grade II, III, or IV acute GVHD. Acute GVHD is graded using the Przepiorka criteria.

Percentage of participants who experienced chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria.

Percentage of patients who engrafted neutrophils and platelets.

Percentage of participants who failed to engraft.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Adverse events were assessed by the investigator and by labwork at each study visit as per protocol.

Non-myeloablative bone marrow transplant with a fludarabine (Flu), cyclophosphamide (Cy), total body irradiation (TBI) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis. Rituximab will be given as post-transplant maintenance.

Fludarabine: Days -6 through -2: 30 mg/m\^2 IV daily

Cyclophosphamide: Days -6 and -5: 14.5 mg/kg IV daily; Days 3 and 4: 50 mg/kg IV daily

Total body irradiation: Day -1: 200 centigray (cGy) in a single fraction

Tacrolimus: Start on Day 5 through Day 180

Mycophenolate Mofetil: Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)

Rituximab: Day 30 and every week after for 8 total doses: 375 mg/m\^2 IV

Transplant

Age, Continuous

>= 60 years old

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Rich Ambinder, MD

All participants

Haploidentical recipients

VV donor

VF donor

FF donor

Populations were analyzed as follows:

1. All participants
2. Recipients of haploidentical donors (69 participants)
3. Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)

Progression-free Survival

Populations were analyzed as follows:

All participants Recipients of haploidentical donors (69 participants) Recipients of VV, VF, and FF donors (17, 43, and 23 participants, respectively, totaling 83 participants)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab	NCT00946023	Lymphoma B-cell Lymphoma Non Hodgkin Lym... Chronic Lymphoc...	Fludarabine Cyclophosphamid... Total body irra... Tacrolimus Mycophenolate M... Rituximab Allogeneic Bone...	1 Year - 75 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab	NCT00946023	Lymphoma B-cell Lymphoma Non Hodgkin Lym... Chronic Lymphoc...	Fludarabine Cyclophosphamid... Total body irra... Tacrolimus Mycophenolate M... Rituximab Allogeneic Bone...	1 Year - 75 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for allogeneic bone marrow transplant (bmt)