MDACC Study Summary 2005-0015

Study Summary
No. 2005-0015:.......Blood And Marrow Transplantation......Paolo Anderlini......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2005-0015

Study Title:	Allogeneic stem cell transplantation followed by adoptive immunotherapy for patients with relapsed and refractory Hodgkin's Disease

Physician

New Patient Referral



Name:	Paolo Anderlini	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8750 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Daily to once weekly from hospital discharge to day 100. Once a month until day 180-360, then every 6-12 months thereafter.

Treatment Agents:	Antithymocyte Globulin Fludarabine Gemcitabine Melphalan	Home Care:	Intravenous fluids/electrolytes, growth factors, antibiotics, antifungals, antivirals.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	One 21-28 days hospitalization (uncomplicated course)


Description/ Intervention:	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.

Study Objectives / Outcomes

1. To determine the efficacy of employing reduced-intensity allogeneic stem cell transplantation followed by adoptive immunotherapy in the form of early immunosuppression withdrawal to maximize a graft-vs-Hodgkin effect in patients with relapsed/refractory Hodgkin's disease (HD).

2. To assess the feasibility and efficacy of incorporating a program of scheduled donor leukocyte infusions (DLIs) in patients with recurrent and persistent or progressive disease after transplantation.

To evaluate the feasibility of incorporating gemcitabine, a highly active agent in HD, in the preparative regimen.

Study Status Information



Study Activation / Registration Date:	07/14/2005

IRB Review and Approval Date:	06/15/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 </=2.0 mg/dl (isolated hyperbilirubinemia related to Gilbert's disease allowed), serum transaminase (ALT) equal to or </= 3 times the upper limit of the normal range, serum creatinine <2.0 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 </=2. Left ventricular ejection fraction >/= 40%, FEV1, FVC and 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.

Links

Registration Number: NCT00385788
Study Information on Clinical Trials Registry (clinicaltrials.gov)