Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT)

Summary

The goal of this clinical research study is to learn what dose of a kind of immune cell called T-lymphocytes (T-cells) given as a donor infusion about 8-9 weeks after a stem cell transplant has the best results. The safety of this treatment will also be studied. This will be tested in patients with leukemia, MDS, lymphoma, Hodgkin disease, and multiple myeloma. These results are measured as helping to control the disease without severe graft-versus-host disease (GvHD). GvHD is when transplanted donor tissue attacks the tissues of the recipient's body.

Fludarabine, melphalan, and alemtuzumab are commonly given before stem cell transplants:

* Fludarabine is designed to interfere with the DNA (genetic material) of cancer cells, which may cause the cancer cells to die.
* Melphalan is designed to bind to the DNA of cells, which may cause cancer cells to die.
* Alemtuzumab is designed to weaken the immune system and reduce the risk of rejection of the transplant and graft-vs-host disease (GvHD).

The donor infusion of T-cells is designed to help restore the immune system after the transplant, cause an immune reaction against the cancer, and reduce the risk of the cancer coming back.

Conditions

• Leukemia
• Lymphoma
• Myeloma
• Myeloproliferative Diseases

Interventions

DRUG

Fludarabine

40 mg/m\^2 by vein on Day -6 to -3.

DRUG

Melphalan

140 mg/m\^2 by vein on Day -2.

DRUG

Alemtuzumab

50 mg by vein on Day -1.

PROCEDURE

Stem Cell Infusion

Reduced intensity stem cell transplant on Day 0.

DRUG

Tacrolimus

0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35.

DRUG

Methotrexate

5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is \> 500 \* 10/L for 3 consecutive days.

PROCEDURE

Low Dose Donor T-Cells

Planned Donor Lymphocyte Infusion CD3+ cells: 3 \* 106 CD3+ cells/kg between Day +56 and +64.

PROCEDURE

High Dose Donor T-Cells

Planned Donor Lymphocyte Infusion CD3+ cells: 1 \* 107 CD3+ cells/kg between Day +56 and +64.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Richard E. Champlin, MD,BS · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• United States

Study Locations