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Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

Phase 2
18 Years
Open (Enrolling)
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis, Anemia, Aplastic, Hemoglobinuria, Paroxysmal

Thank you

Trial Information

Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

This study is for patients with a blood condition or myelodysplasia (bone marrow disease)
which has either not responded to treatment or is not treatable by conventional/routine
medical treatments. Bone marrow transplantation is a medical treatment that involves giving
high doses of chemotherapy followed by the transplantation of the blood-forming and immune
cells from a relative or from a "matched" unrelated person through the National Marrow Donor
Program, in an attempt to cure disease in the recipient (the person receiving the donated
cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a
relatively new technique in which lower than usual doses of chemotherapy are given before
transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant
patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors
have determined are beneficial for this condition.

This research is being done because the complication of graft-versus-host disease can be bad
for a person and there is no completely safe and effective way to prevent this complication.
We know that cyclosporine helps but would like to know if the addition of basiliximab,
given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host
disease after a transplant known as nonmyeloablative or "mini" transplant.

Inclusion Criteria:

- Acute myelogenous leukemia:

- Second or subsequent remission; patient over 18 yrs of age.

- Relapsed after autologous HC transplant, over 18 years of age.

- First remission, Philadelphia chromosome + over age 18.

- Secondary AML, in first or subsequent remissions.

- Acute lymphocytic leukemia:

- Philadelphia chromosome + over the age of 50, first or subsequent remission.

- Relapse following Autologous HC transplantation, ages over 50.

- Second or subsequent remission over the age of 50

- Chronic myelogenous leukemia:

- First or second chronic phase over the age of 18.

- Accelerated phase over the age of 18.

- Must have failed or been intolerant to a standard tyrosine kinase inhibitor.

- Chronic lymphocytic leukemia:

- Failed nucleoside-based therapy, ages >18.

- Myelodysplasia:

- All-risk categories, age greater than 18.

- Non-Hodgkin's Lymphoma, less than 76 years of age

- Relapsed diffuse aggressive NHL (intermediate and high grade) that fails to
achieve CR or PR to conventional salvage chemotherapy.

- Aggressive NHL includes diffuse large B cell lymphoma, diffuse mixed small and
large cell lymphoma, follicular lymphoma for grade 3 (follicular large cell
lymphoma), T or B cell lymphoblastic lymphoma, diffuse small noncleaved
(Burkett's or Burkett-like ) lymphoma, mantle cell lymphoma, peripheral T cell
lymphoma, anaplastic large cell lymphoma, and other diffuse aggressive lymphomas
that are not otherwise classifiable

- Aggressive NHL that has relapsed following autologous HCT. Patients that
respond to additional treatment for post-transplant relapse are eligible.

- Aggressive NHL that does not achieve CR or PR with primary chemotherapy (i.e.,
primary induction failure).

- Low-grade lymphoma refractory to standard therapy, including the following:

1. small cell lymphocytic lymphoma,

2. follicular lymphoma of grades 1 and 2 (follicular small cleaved and
follicular mixed small and large cell lymphoma)

3. marginal cell lymphoma, splenic lymphoma),

4. lymphoplasmacytic lymphoma and

5. other lymphomas not otherwise classifiable.

- Patients with low-grade lymphoma must have experienced progressive disease after
receiving three or more of the following regimens:

- alkylator-based therapy (cyclophosphamide/ vincristine/ prednisone)
chlorambucil, monoclonal antibody based therapy (e.g., rituximab, Campath-1H,
radiolabelled CD20+ antibodies);

- nucleoside analog-based therapy (e.g., fludarabine, cladribine).)

- Patients with marginal zone lymphoma or gastric MALT type associated with
Helicobacter pylori infection must have progressed after receiving appropriate
antibiotic therapy as well as three or more regimens as described above

- Mantle cell, ages 18-75.

- Hodgkin's Disease, ages 18-75.

- Relapsed or refractory disease after autologous transplant.

- Multiple Myeloma, ages 18-75

- Recurrent disease after two medical therapies

- Relapse following autologous transplant

- Myelofibrosis, age greater than 18 years

- Severe aplastic anemia (refractory to immunosuppressive therapy); age greater than 18

- Patients with aplastic anemia must have marrow cellularity ≤ 10% plus 2 of the

1. Absolute granulocyte count <500/mm3

2. Corrected reticulocyte count <1%

3. Untransfused platelet count <20,000/mm3 on at least 2 occasions

4. Hemoglobin <9 g/dL (adults) or < 8 g/dL (children) on at least 2 occasions

- Paroxysmal nocturnal hemoglobinuria; age greater than 18 years.

- Renal function: creatinine greater than 2.5

- Donor Requirement:

- Must have a fully HLA-matched (10 of 10 Antigen matched) related or unrelated
donor, eighteen years of age or older, who is capable of undergoing GCSF
mobilization and apheresis

Exclusion Criteria:

- Active CNS disease (the presence of leukemic blasts in the CSF)

- Pregnancy or breast-feeding.

- Inability to give informed consent.

- AST, ALT, total bilirubin >3x upper limit of normal.

- Creatinine > 2 or creatinine clearance < 50mL/hr. If patient has a creatinine of > 2
or creatinine clearance < 50mL/hr and it is due to the disease process then the
patient will not be excluded based on this.

- Fractional shortening by echocardiogram not within normal limits per institution or
LVEF of < 40 %.

- Pulmonary function: DLCO not within institutional normal limits or DLCO less than
45% of normal predicted, corrected for anemia

- Prior allogeneic transplant.

Type of Study:


Study Design:

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

Outcome Measure:

Assess the incidence grade 3-4 aGVHD; Compare the incidence of grade 3-4 aGVHD with those of a recently completed clinical trial cohort

Outcome Time Frame:

Pre-Transplant thru 1 year post transplant

Safety Issue:


Principal Investigator

Robert Nelson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine


United States: Institutional Review Board

Study ID:

0908-04; IUCRO-0256



Start Date:

September 2009

Completion Date:

October 2014

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Lymphocytic Leukemia
  • Myelodysplasia
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Multiple Myeloma
  • Myelofibrosis
  • Anemia, Aplastic
  • Hemoglobinuria, Paroxysmal
  • Paroxysmal nocturnal hemoglobinuria
  • severe aplastic anemia
  • Mantle cell
  • Primary Myelofibrosis
  • Anemia
  • Anemia, Aplastic
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265