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Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients


Phase 1
6 Months
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma, Myeloproliferative Diseases

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Trial Information

Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients


You have had a UCBT. A small amount of the previously infused cord blood was frozen. This
saved cord blood will be treated at the MD Anderson Stem Cell Laboratory with interleukin-2
(IL-2) and clinical beads to produce and help generate the needed T cells. This will take
about 2 weeks. When the product is ready, you will be given the expanded cord blood T cells
as an infusion through your central venous catheter (CVC).

Cord Blood T Cell Infusion:

You will be assigned to a dose level of cord blood T cells based on when you joined this
study. The first group of participants will receive the lowest dose level. Each new group
will receive a higher dose than the group before it, if no intolerable side effects were
seen. This will continue for up to 3 dose levels, until the highest tolerable dose of cord
blood is found.

You will receive the cord blood T cells through your CVC. You will be given standard drugs
to help decrease the risk of side effects. You may ask the study staff for information about
how the drugs are given and their risks.

Study Tests:

Before the cord blood T cell infusion:

- Your medical history will be recorded, and you will have a physical exam.

- Blood (about 4-6 teaspoons) will be drawn for routine tests, to test for
cytomegalovirus (CMV), and to see how well the transplant has taken.

After the cord blood T cell infusion:

- Your vital signs will be measured (blood pressure, heart rate, temperature, and
breathing rate).

- You will have a pulse oximetry test to check the amount of oxygen in your blood. For
this test a clothespin-shaped clip will be placed on your finger for about 1 minute.

One day after the cord blood T cell infusion:

- You will have a physical exam.

- You will be asked about how you are feeling and about any side effects you may be
having.

- You will be checked for possible reactions to the infusion, including graft versus host
disease (GVHD - a condition in which transplanted tissue attacks the body into which it
is transplanted).

- Blood (about 4-6 teaspoons) will be drawn for routine tests and to test for CMV.

One time a week for the first 3 weeks after the cord blood T cell infusion:

- Your medical history will be recorded, and you will have a physical exam.

- You will be asked about how you are feeling and about any side effects you may be
having.

- You will be checked for possible reactions to the infusion, including GVHD.

- Blood (4-6 teaspoons) will be drawn for routine tests and to test for CMV.

At 1 month after the cord blood T cell infusion:

- Your medical history will be recorded, and you will have a physical exam.

- You will be asked about how you are feeling and about any side effects you may be
having.

- You will be checked for possible reactions to the infusion, including GVHD.

- Blood (about 4-6 teaspoons) will be drawn for routine tests, to test for CMV, and to
learn if and how well the transplant has taken.

- You may have a bone marrow biopsy/aspirate to check the status of the disease. To
collect a bone marrow biopsy/aspirate, an area of the hip is numbed with anesthetic,
and a small amount of bone and bone marrow is withdrawn through a large needle.

- You may have imaging scans to check the status of the disease and/or to check for
possible infections.

End-of-Study Visit:

At about 100 days after the cord blood T cell infusion:

- Your medical history will be recorded, and you will have a physical exam.

- You will be asked about how you are feeling and about any side effects you may be
having.

- You will be checked for possible reactions to the infusion, including GVHD.

- Blood (about 4-6 teaspoons) will be drawn for routine tests, to test for CMV, and to
learn if and how well the transplant has taken.

Length of Study:

You will be on study for about 100 days after the cord blood T cell infusion. You may be
taken off study early if the disease gets worse, if there is not enough cord blood to
infuse, if it cannot be infused due to infection/contamination, if you have any intolerable
side effects, or if you are unable to follow study directions.

You should talk to the study doctor if you want to leave the study early. If you are taken
off study early, you still may need to return for routine post-transplant follow-up visits,
if your transplant doctor decides it is needed.

This is an investigational study. The cord blood T cell expansion procedure is not FDA
approved or commercially available. It is currently being used for research purposes only.

Up to 18 participants will be enrolled in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. UCB recipients with underlying hematological malignancies presenting with post
transplant relapse and have available a 400 microliter aliquots or CB wash from
previous transplant.

2. Patient's Age Criteria: Age greater than 5 months old. Eligibility for pediatric
patients will be determined in conjunction with an MDACC pediatrician.

3. Performance score of at least 80% by Karnofsky or PS < 3 (ECOG) (age >/= 12 years),
or Lansky Play-Performance Scale of at least 60% or greater (age <12 years).

4. Left ventricular ejection function of at least 50%.

5. Pulmonary function test demonstrating a diffusion capacity of at least 50% predicted.
If unable to perform pulmonary function test (most children <6 years of age), pulse
oximetry >/= 92% on room air.

6. Creatinine threshold of < 1.6 mg/dL or creatinine clearance >/= 50 ml/min.

7. Liver Function, ALT/AST to 3.0 x normal.

8. Negative Beta HCG or urine test in females of childbearing potential defined as not
post-menopausal for 12 months or no previous surgical sterilization and willing to
use an effective contraceptive measure while on the study.

9. Patient or patient's legal representative, parent(s) or guardian able to sign
informed consent.

Exclusion Criteria:

1. HIV positive (due to the extreme immunosuppressive nature of allogeneic stem cell
transplant).

2. Patients with active (untreated) CNS disease.

3. Any GVHD.

4. Active invasive infections.

5. Pregnant or breast-feeding.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose (MTD) of ex vivo Expanded Cord Blood T Cells

Outcome Description:

Maximum tolerated dose (MTD) defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30%.

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Simrit Parmar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2011-1178

NCT ID:

NCT01630564

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myeloproliferative Diseases
  • Blood And Marrow Transplantation
  • Leukemia
  • Lymphoma
  • Myeloproliferative Diseases
  • Relapsed hematological malignancies
  • Post-Transplant Relapsed Patients
  • Cord Blood Lymphocyte Infusion
  • Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion
  • Leukemia
  • Lymphoma
  • Myeloproliferative Disorders

Name

Location

UT MD Andreson Cancer CenterHouston, Texas  77030