Overview

Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease

Status:
Completed

Trial end date:
2016-08-01

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Antilymphocyte Serum
Fludarabine
Fludarabine phosphate
Gemcitabine
Lenograstim
Melphalan
Methotrexate
Tacrolimus
Thymoglobulin
Vidarabine

Criteria

Inclusion Criteria:

1. Patients < 65 years of age with histologically confirmed refractory or relapsed
Hodgkin's disease (including patients who fail or relapse after autologous SCT). This
upper age limit will apply to transplants from both matched related and unrelated
donors.

2. Patients should have any of the following disease status: a. responsive or stable
disease on salvage chemotherapy or radiation therapy. b. untreated, smoldering (i.e.
not rapidly progressive) relapses.

3. Patients must have a serum bilirubin equal to or hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT)
equal to or mg/dl (provided they also have a glomerular filtration rate of at least 55 ml/min), no
symptomatic cardiac or pulmonary disease and a performance status equal to or Left ventricular ejection fraction >/= 40%, forced expiratory volume at one second
(FEV1), forced vital capacity (FVC) and corrected diffusing capacity of lung for
carbon monoxide (DLCO) >/= 50% predicted.

4. Patients must have an HLA-compatible related or unrelated donor (one-antigen
mismatched related donors are acceptable) willing to donate marrow or
rhG-CSF-mobilized peripheral blood stem cells. In the event of transplants from
matched unrelated donors, a high-resolution allele match for HLA-A, -B, -C, -DRB1 ("8
of 8 match") is required.

5. Women of childbearing potential must have a negative serum pregnancy test within two
weeks of study entry and should be advised to avoid becoming pregnant. Men should be
advised to not father a child while on treatment. Both women of childbearing potential
and men must agree to practice effective methods of contraception.

6. Patients must be capable and willing to sign informed consent.

Exclusion Criteria:

1. Patients with documented disease progression on salvage chemotherapy.

2. Nursing or pregnant females. Should a woman become pregnant or suspect she is pregnant
while participating in the study, she should inform her treating physician
immediately.

3. Severe concomitant medical or psychiatric illness.

4. Uncontrolled arrhythmia or symptomatic cardiac or pulmonary disease.

5. Chronic active hepatitis or cirrhosis.

6. Active or uncontrolled infection.

7. Radiation therapy involving chest (axilla excluded), mediastinum, or abdomen (i.e.,
small or large bowel) completed within 10 weeks of transplant admission. Radiation
therapy shortly before the start of the preparative regimen is allowed.

8. Prior or concurrent malignancies (including myelodysplasia) except resected basal cell
carcinoma or treated carcinoma in-situ. Cancer treated with curative intent < 5 years
previously will not be allowed unless approved by the Protocol Chair. Cancer treated
with curative intent > 5 years previously will be allowed.