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CompletedNCT00975975Updated Feb 26, 2016Results posted

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

A Phase 2 interventional study of Basiliximab in Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia and Chronic Myelogenous Leukemia, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by Indiana University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.

Read the detailed description

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.

02

Conditions studied

  • 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

Keywords

  • Paroxysmal nocturnal hemoglobinuria
  • severe aplastic anemia
  • Mantle cell
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In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's enrollment of 17 is below the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 years

    • Patients with aplastic anemia must have marrow cellularity ≤ 10% plus 2 of the following:

      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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Basiliximab

    Basiliximab will be given by IV on Day +7 post transplant for recipients of matched unrelated cells. Basiliximab will be given by IV on Day +9 post transplant for recipients of matched related cells.

    Drug: Basiliximab

Interventions

  • DrugBasiliximab

    Basiliximab given 1 time on Day +7 or Day +9.

    Also known as: Simulect

06

What researchers measure

Primary outcomes

  1. Grade 3-4 Acute GVHD Rate

    The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD

    Time frame: Transplant (Day 0) up to 1 year

Secondary outcomes

  1. Time to Neutrophil Engraftment

    Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

    Time frame: Transplant (Day 0) up to 1 year

  2. Time to Platelet Engraftment

    Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

    Time frame: Transplant (Day 0) up to 1 year

07

Results

Posted Feb 26, 2016

Participant flow

This protocol has 17 patients. The study was stopped prior to 20 due to the meeting of a stopping rule of 5 or more deaths within the first 15 patients. An additional patient was enrolled after the stopping rule was met. This patient was followed for safety/AE but is not included in the analysis of the efficacy measures, as recommended by the IRB.

Participant flow — Overall Study
MilestoneOverall
Started17
Completed11
Not completed6
Withdrew: Death6

Outcome measures

PrimaryGrade 3-4 Acute GVHD Rate

The percent of patients where a patient experienced a Grade 3 or 4 acute GVHD

Time frame:
Transplant (Day 0) up to 1 year
Reported as:
Number · percentage of participants
Grade 3-4 Acute GVHD Rate
percentage of participantsOverall
Grade 3-4 Acute GVHD Rate29.4 (10.3 to 56.0)
SecondaryTime to Neutrophil Engraftment

Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

Time frame:
Transplant (Day 0) up to 1 year
Reported as:
Median · days
Time to Neutrophil Engraftment
daysOverall
Time to Neutrophil Engraftment13.5 (10.0 to 14.0)
SecondaryTime to Platelet Engraftment

Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Patients who did not have platelet engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.

Time frame:
Transplant (Day 0) up to 1 year
Reported as:
Median · days
Time to Platelet Engraftment
daysOverall
Time to Platelet Engraftment12.0 (8.0 to 18.0)

Adverse events

Collected over From transplant until the end of the study, for up to 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overall—7/17 (41.2%)17/17 (100%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventOverall
INFECTION - OTHERInfections and infestations4/17
DIARRHEAGastrointestinal disorders2/17
PAIN - ABDOMEN NOSGastrointestinal disorders2/17
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)General disorders2/17
INFECTION WITH UNKNOWN ANC - BLOODInfections and infestations2/17
CREATININEInvestigations2/17
HYPOXIARespiratory, thoracic and mediastinal disorders2/17
CARDIAC ARRHYTHMIA - OTHERCardiac disorders1/17
CONDUCTION ABNORMALITY/ATRIOVENTRICULAR HEART BLOCK - ASYSTOLECardiac disorders1/17
GASTROINTESTINAL - OTHERGastrointestinal disorders1/17
Most frequent other events
Showing 10 of 135
Most frequent other events
EventOverall
DIARRHEAGastrointestinal disorders14/17
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)General disorders14/17
BILIRUBIN (HYPERBILIRUBINEMIA)Hepatobiliary disorders14/17
INFECTION - OTHERInfections and infestations14/17
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)Investigations14/17
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)Investigations14/17
CREATININEInvestigations14/17
EDEMA: LIMBMetabolism and nutrition disorders14/17
ALKALINE PHOSPHATASEInvestigations12/17
DYSPNEA (SHORTNESS OF BREATH)Respiratory, thoracic and mediastinal disorders12/17

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overall
Mean59.1 ± 7.05
Sex: Female, Male
Sex: Female, Male(Participants)Overall
Female8
Male9
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White17
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Indiana University Cancer Center
    Indianapolis, Indiana 46202, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00975975
Lead sponsor
Indiana University School of Medicine
Responsible party
Sponsor
First posted
Sep 14, 2009
Start date
Sep 2009
Primary completion
Oct 2012
Completion
Nov 2013
Results posted
Feb 26, 2016
Last update
Feb 26, 2016

Study contacts

Robert Nelson, MD
principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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