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Phase 2 Study of Planned Donor Lymphocyte Infusion After Reduced Intensity Allogeneic Stem Cell Transplantation

Phase 2
18 Years
65 Years
Open (Enrolling)
Leukemia, Lymphoma, Myeloma, Myeloproliferative Diseases

Thank you

Trial Information

Phase 2 Study of Planned Donor Lymphocyte Infusion After Reduced Intensity Allogeneic Stem Cell Transplantation

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 study groups involving the dose of T-cells in the donor lymphocyte infusion.

- Group 1 will receive a low dose of donor T-cells.

- Group 2 will receive a higher dose of donor T-cells than Group 1.

Both you and your study doctor will know which group you are in. Both groups will have a
stem cell transplant. The stem cells will be given by vein. The cells will travel to your
bone marrow where they are designed to make healthy, new blood cells after several weeks.

Study Drug Administration:

Patients receive fludarabine, melphalan and alemtuzumab to kill malignant cells and suppress
immunity to prevent rejection of the stem cell transplant. The day you receive the stem
cells is called Day 0. The days before you receive your stem cells are called minus days.
The days after you receive the stem cells are called plus days.

On Day -7, you will be admitted to the hospital and given fluids by vein to hydrate you.

On Days -6 through -3, you will receive fludarabine by vein over 1 hour each day.

On Day -2, you will receive melphalan by vein over 30 minutes.

On Day -1, you will receive alemtuzumab by vein over 2 hours.

On Day 0, you will receive the stem cell transplant as a cell infusion by vein.

After the transplant, you will receive tacrolimus and methotrexate. At first, you will
receive tacrolimus as a continuous (nonstop) infusion until you are able to take it by
mouth. You will then take tacrolimus by mouth 2 times a day for about 5 weeks and then your
doctor will tell you how to taper it off (gradually stop taking it). On Days 1, 3, and 6
after the transplant, you will receive methotrexate by vein over 30 minutes.

You will receive filgrastim as an injection under the skin 1 time a day, starting 1 week
after the transplant, until your blood cell levels return to normal. Filgrastim is designed
to help with the growth of white blood cells.

Between Day +56 and +64, if you are in stable medical condition and have not developed GvHD,
you will receive a donor lymphocyte infusion containing T-cells by vein over 10-30 minutes.
You will receive Benadryl (diphenhydramine) by vein over 15 minutes before the infusion to
lower the risk of an allergic reaction.

Study Visits:

Before the T-cell infusion:

- You will have a physical exam, including measurement of your vital signs (blood
pressure, heart rate, temperature, and breathing rate).

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

- Blood (about 2 teaspoons) will be drawn to see how well the transplant has "taken".

- You will have a bone marrow aspiration and biopsy to check the status of the disease,
if your doctor thinks it is needed. To collect a bone marrow aspiration/biopsy, an
area of the hip or other site is numbed with anesthetic, and a small amount of bone
marrow and bone is withdrawn through a large needle.

After the T-cell infusion, you will have a physical exam every week for at least 6 weeks.

About 3, 6, and 12 months after the transplant:

- You will have a physical exam, including measurement of your vital signs.

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

- Blood (about 4 tablespoons) will be drawn for routine tests and to check the level of
the infused T-cells, for immune function tests, and to check the status of the disease.

- You will have a bone marrow aspiration, blood tests and CT scans as medically necessary
to check the status of the disease, if your doctor thinks it is needed.

During the study, you will have blood draws (about 2 teaspoons) and urine will be collected
for routine tests, to check your blood counts, kidney and liver function, and/or to check
for infections as often as the doctor thinks is needed during this time.

Length of Treatment:

You will be off study after your 12-month follow-up visit. You will be taken off study
early if you have graft failure (the donor cells did not "take") or if the cancer comes back
and needs another treatment.

This is an investigational study. Melphalan, fludarabine, and alemtuzumab are FDA approved
and commercially available for the treatment of blood cancers. Donor T-cell infusions are
commonly used to treat blood cancers that come back after a stem cell transplant. The
investigational part of this study is to find the best dose of T-cells that are given with
the goal of helping to prevent the cancer from coming back.

Up to 56 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Age >/= 18 years and first remission, in first or subsequent relapse, in second or greater remission.
Patients in first remission should have intermediate or high cytogenetic risk factors
or flt3 mutation. Patients with primary induction failure or relapse are eligible if
they have <10% bone marrow blasts, and no circulating blasts. b. Myelodysplastic
syndrome with intermediate or high risk IPSS score, or treatment related MDS. c. CML
resistant to tyrosine kinase inhibitor treatment in a first or subsequent chronic
phase, or in accelerated phase. d. CLL, Lymphoma or Hodgkin's disease which has
failed to achieve remission or recurred following initial chemotherapy. Patients must
have at least a PR to salvage therapy, or low bulk untreated relapse (<2 cm largest
mass). e. Multiple myeloma which has relapsed or progressed and has achieved a
partial response to salvage chemotherapy.

2. Patients must have one of the following donor types identified and willing to donate:
a. Related donor, HLA-matched for HLA-A, -B, C and DR matched or, b. Matched
Unrelated Donor (MUD), HLA-matched for HLA A, B, C and DRB1 using allele level

3. Performance score of at least 80% by Karnofsky or performance score 0 to 2 (ECOG).

4. Estimated creatinine clearance >40 ml/min (based on serum creatinine)

5. Bilirubin <1.5 mg/dl except for Gilbert's disease.

6. ALT < 300 IU/ml d.

7. Left ventricular ejection fraction equal or greater than 40%.

8. Pulmonary function test (PFT) demonstrating a diffusion capacity (corrected for
hemoglobin) of least 50% predicted.

9. Patient or patient's legal representative able to sign informed consent.

Exclusion Criteria:

1. Patients who have had prior autologous transplants or prior allogeneic transplants
are not eligible.

2. Uncontrolled active infection.

3. Positive Beta HCG test in a woman with child bearing potential, defined as not
post-menopausal for 12 months or no previous surgical sterilization.

4. Women of child bearing potential not willing to use an effective contraceptive
measure while on study.

5. Subject has known sensitivity to any of the products that will be administered during
the study.

6. Patients who are HIV seropositive.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Success Rate

Outcome Description:

Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allotx.

Outcome Time Frame:

100 days

Safety Issue:


Principal Investigator

Richard E. Champlin, MD,BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myeloma
  • Myeloproliferative Diseases
  • Blood and Marrow Transplantation
  • Lymphoma
  • Myeloma
  • Myeloproliferative Diseases
  • Leukemia
  • Myelodysplastic syndrome
  • MDS
  • Hodgkin disease
  • Multiple myeloma
  • Fludarabine
  • Fludarabine Phosphate
  • Fludara
  • Melphalan
  • Alkeran
  • Tacrolimus
  • Prograf
  • Methotrexate
  • G-CSF
  • Filgrastim
  • NeupogenTM
  • Donor Lymphocyte Infusion
  • DLI
  • Allogeneic Stem Cell Transplantation
  • Graft-vs-host disease
  • GvHD
  • T-lymphocytes
  • T-cells
  • Alemtuzumab
  • Campath
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myeloproliferative Disorders



UT MD Anderson Cancer Center Houston, Texas  77030