Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia
• Adult Acute Lymphoblastic Leukemia in Remission
• Adult Acute Myeloid Leukemia in Remission
• Adult Nasal Type Extranodal NK/T-cell Lymphoma
• Blastic Phase Chronic Myelogenous Leukemia
• Contiguous Stage II Adult Burkitt Lymphoma
• Contiguous Stage II Adult Diffuse Large Cell Lymphoma
• Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
• Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
• Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
• Contiguous Stage II Adult Lymphoblastic Lymphoma
• Contiguous Stage II Grade 1 Follicular Lymphoma
• Contiguous Stage II Grade 2 Follicular Lymphoma
• Contiguous Stage II Grade 3 Follicular Lymphoma
• Contiguous Stage II Mantle Cell Lymphoma
• Contiguous Stage II Marginal Zone Lymphoma
• Contiguous Stage II Small Lymphocytic Lymphoma
• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Graft Versus Host Disease
• Nodal Marginal Zone B-cell Lymphoma
• Noncontiguous Stage II Adult Burkitt Lymphoma
• Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
• Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
• Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
• Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
• Noncontiguous Stage II Adult Lymphoblastic Lymphoma
• Noncontiguous Stage II Grade 1 Follicular Lymphoma
• Noncontiguous Stage II Grade 2 Follicular Lymphoma
• Noncontiguous Stage II Grade 3 Follicular Lymphoma
• Noncontiguous Stage II Mantle Cell Lymphoma
• Noncontiguous Stage II Marginal Zone Lymphoma
• Noncontiguous Stage II Small Lymphocytic Lymphoma
• Previously Treated Myelodysplastic Syndromes
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Adult Burkitt Lymphoma
• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Adult Diffuse Mixed Cell Lymphoma
• Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
• Recurrent Adult Grade III Lymphomatoid Granulomatosis
• Recurrent Adult Immunoblastic Large Cell Lymphoma
• Recurrent Adult Lymphoblastic Lymphoma
• Recurrent Adult T-cell Leukemia/Lymphoma
• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Relapsing Chronic Myelogenous Leukemia
• Secondary Myelodysplastic Syndromes
• Splenic Marginal Zone Lymphoma
• Stage I Adult Burkitt Lymphoma
• Stage I Adult Diffuse Large Cell Lymphoma
• Stage I Adult Diffuse Mixed Cell Lymphoma
• Stage I Adult Diffuse Small Cleaved Cell Lymphoma
• Stage I Adult Immunoblastic Large Cell Lymphoma
• Stage I Adult Lymphoblastic Lymphoma
• Stage I Adult T-cell Leukemia/Lymphoma
• Stage I Chronic Lymphocytic Leukemia
• Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage I Grade 1 Follicular Lymphoma
• Stage I Grade 2 Follicular Lymphoma
• Stage I Grade 3 Follicular Lymphoma
• Stage I Mantle Cell Lymphoma
• Stage I Marginal Zone Lymphoma
• Stage I Mycosis Fungoides/Sezary Syndrome
• Stage I Small Lymphocytic Lymphoma
• Stage II Adult T-cell Leukemia/Lymphoma
• Stage II Chronic Lymphocytic Leukemia
• Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage II Mycosis Fungoides/Sezary Syndrome
• Stage III Adult Burkitt Lymphoma
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage III Adult Diffuse Mixed Cell Lymphoma
• Stage III Adult Diffuse Small Cleaved Cell Lymphoma
• Stage III Adult Immunoblastic Large Cell Lymphoma
• Stage III Adult Lymphoblastic Lymphoma
• Stage III Adult T-cell Leukemia/Lymphoma
• Stage III Chronic Lymphocytic Leukemia
• Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage III Grade 1 Follicular Lymphoma
• Stage III Grade 2 Follicular Lymphoma
• Stage III Grade 3 Follicular Lymphoma
• Stage III Mantle Cell Lymphoma
• Stage III Marginal Zone Lymphoma
• Stage III Mycosis Fungoides/Sezary Syndrome
• Stage III Small Lymphocytic Lymphoma
• Stage IV Adult Burkitt Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma
• Stage IV Adult Diffuse Mixed Cell Lymphoma
• Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
• Stage IV Adult Immunoblastic Large Cell Lymphoma
• Stage IV Adult Lymphoblastic Lymphoma
• Stage IV Adult T-cell Leukemia/Lymphoma
• Stage IV Chronic Lymphocytic Leukemia
• Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IV Grade 1 Follicular Lymphoma
• Stage IV Grade 2 Follicular Lymphoma
• Stage IV Grade 3 Follicular Lymphoma
• Stage IV Mantle Cell Lymphoma
• Stage IV Marginal Zone Lymphoma
• Stage IV Mycosis Fungoides/Sezary Syndrome
• Stage IV Small Lymphocytic Lymphoma
• Untreated Adult Acute Lymphoblastic Leukemia
• Untreated Adult Acute Myeloid Leukemia
• Waldenström Macroglobulinemia
• de Novo Myelodysplastic Syndromes

Eligibility Criteria

Sex

ALL

Age

19 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• rituximab — DRUG
  Given IV
• mycophenolate mofetil — DRUG
  Given IV or PO
• tacrolimus — DRUG
  Given IV
• anti-thymocyte globulin — DRUG
  Given IV
• allogeneic hematopoietic stem cell transplantation — PROCEDURE
  Stem cell transplant
• laboratory biomarker analysis — OTHER
  Correlative studies
• graft versus host disease prophylaxis/therapy — BIOLOGICAL
  Undergo graft versus host disease prophylaxis/therapy
• cyclophosphamide — DRUG
  Given PO or IV
• fludarabine phosphate — DRUG
  Given IV
• busulfan — DRUG
  Given IV
• total-body irradiation — RADIATION
  Undergo TBI
• graft-versus-tumor induction therapy — BIOLOGICAL
  Undergo graft-versus-tumor induction therapy
• immunosuppressive therapy — BIOLOGICAL
  Undergo immunosuppressive therapy

Study Details

This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening

Key Dates

Start date

Dec 10, 2009

Status verified

Aug 2023

Primary completion

Dec 19, 2012

Completion

Oct 10, 2017

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (Rituximab and allogeneic HCT transplant)
  CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0.

Primary Outcome Measure

Number of Participants With Grades II-IV Acute GVHD [ Time Frame: At day 100 ]

Locations (1)

Find similar trials in Omaha, NE

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