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Nonmyeloablative BMT With Post-transplant Cyclophosphamide, Rituximab and Optimized Donor Selection for B-cell Lymphomas


Phase 2
1 Year
75 Years
Open (Enrolling)
Both
Lymphoma, B-cell Lymphoma, Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

Nonmyeloablative BMT With Post-transplant Cyclophosphamide, Rituximab and Optimized Donor Selection for B-cell Lymphomas


This phase II for relapsed or refractory B-cell malignancies builds on the platform of
nonmyeloablative, related-donor, HLA-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.


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 or CR, 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 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 and AST
no more than 5 x upper limit of normal

- FEV1 and FVC 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 performance status greater than 1 (2,3, and 4)

- HIV positive

- Pregnant or breastfeeding

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Yvette L Kasamon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

J0941

NCT ID:

NCT00946023

Start Date:

July 2009

Completion Date:

August 2015

Related Keywords:

  • Lymphoma
  • B-Cell Lymphoma
  • Non Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
  • lymphoma
  • non hodgkin lymphoma
  • allogeneic
  • bone marrow transplantation
  • nonmyeloablative
  • cyclophosphamide
  • rituximab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410